−Removed: We are a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.
−Removed: We use our proprietary platform to develop product candidates that stimulate powerful, targeted immune responses against pathogens and tumor cells.
−Removed: We design our product candidates to stimulate immune responses that are robust, highly specific, and are differentiated by the magnitude of the T cell populations induced, which exhibit critical functionality and durability.
−Removed: We are focused on applying our platform capabilities and the expertise of our team to address significant unmet medical needs in two settings—the therapeutic setting, for the treatment of chronic infectious diseases and cancer, and the prophylactic setting, for the prevention of infectious diseases, based on our platform’s ability to respond rapidly to epidemic and pandemic threats.
+Added: We are a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases, cancer, and autoimmunity.
+Added: We aim to treat and prevent infectious diseases and cancer by using our proprietary platforms to develop product candidates that stimulate powerful, targeted immune responses against pathogens, infected cells, and tumor cells.
+Added: We design these product candidates to stimulate immune responses that are robust, highly specific, and are differentiated by the magnitude of the T cell populations induced, which exhibit critical functionality and durability.
+Added: In the field of autoimmunity, we use our proprietary platform to develop product candidates that are designed to induce regulatory T cells to suppress specifically pathogenic autoimmune responses and prevent/reverse autoimmunity.
+Added: We are focused on applying our platform capabilities and the expertise of our team to address significant unmet medical needs in two settings—the therapeutic setting, for the treatment of chronic infectious diseases, cancer, and autoimmunity;
+Added: and the prophylactic setting, for the prevention of infectious diseases, based on our platform’s ability to respond rapidly to epidemic and pandemic threats.
We have a broad pipeline of both clinical and preclinical stage therapeutic and prophylactic programs.
−Removed: Our current therapeutic programs include VTP-300 for the treatment of chronic hepatitis B infection, or CHB, VTP-200 for the treatment of human papilloma virus infection, or HPV, VTP-850 for the treatment of prostate cancer and VTP-600 for the treatment of non-small cell lung cancer, or NSCLC.
+Added: Our current therapeutic programs include VTP-300 for the treatment of chronic hepatitis B infection, or CHB, VTP-200 for the treatment of human papilloma virus infection, or HPV, VTP-850 for the treatment of prostate cancer, VTP-600 for the treatment of non-small cell lung cancer, or NSCLC, VTP-1000 for treatment of celiac disease, and VTP-1100 for treatment of HPV-associated cancers.
+Added: The latter two programs are designed to utilize our SNAPvax TM platform.
Our current prophylactic programs include VTP-400 for the prevention of herpes zoster, or shingles, and VTP-500 for the prevention of Middle East respiratory syndrome, or MERS.
−Removed: In addition, we co-invented a COVID-19 vaccine candidate with the University of Oxford, which we assigned to Oxford University Innovation, or OUI, to facilitate the license of those rights by OUI to AstraZeneca UK Limited, or AstraZeneca.
+Added: In addition, we co-invented a COVID-19 vaccine with the University of Oxford, the rights to which we assigned to Oxford University Innovation, or OUI, to facilitate the license of those rights by OUI to AstraZeneca UK Limited, or AstraZeneca.
The vaccine, formerly referred to as AZD1222, is now authorized for use under the marketing name Vaxzevria in a number of countries.
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Scientists have successfully harnessed the immune system to prevent and treat diseases using a wide range of approaches over hundreds of years.
−Removed: In the prophylactic setting, vaccines aim to create lasting protective immunity, while in the therapeutic setting, immunotherapeutics aim to enhance the body’s immune response to pathogens and infected or cancerous cells to enable a cure.
+Added: In the prophylactic setting, vaccines aim to create long-lasting protective immunity, while in the therapeutic setting, immunotherapeutics aim to balance the body’s immune response either by strengthening it to enable clearance of pathogens and infected or cancerous cells, or by dampening it to limit inflammation and tissue damage due to autoimmune hyperactivity.
A key element of the immune system is specialized white blood cells, or lymphocytes.
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B cells are responsible for generating antibodies while T cells assist in the clearance of acute and chronic infections, such as hepatitis B virus and HPV, and are involved in killing cells that become cancerous.
−Removed: Over the past three decades, hundreds of vaccine and immunotherapy trials have examined a wide variety of approaches that induce the production of cytotoxic, or CD8+, T cells against infected and cancerous cells.
−Removed: These trials have demonstrated that different vaccine and immunotherapy approaches induce different breadths and magnitudes of immune response.
+Added: Although designed to be protective, these immune cells can also be hyperactive and, when targeted against self, they are responsible for tissue-specific damage in many autoimmune conditions.
+Added: Over the past three decades, hundreds of trials have examined a wide variety of approaches that induce the production of cytotoxic, or CD8+, T cells against infected and cancerous cells.
+Added: These trials have demonstrated that different approaches induce different breadths and magnitudes of immune response.
While there have been many successes, certain diseases requiring a robust CD8+ T cell response have remained resistant to existing approaches.
Infected or cancerous cells are recognized through specific molecules, or antigens, which induce an immune response in the human body.
−Removed: Our platform is designed to stimulate the production of very high levels of T cells, in addition to antibodies, against such antigens.
−Removed: Our approach for the treatment or prevention of a disease with a known target antigen is to prime the immune system with an initial injection of a proprietary adenovirus vector encoded with the target antigen.
−Removed: In the therapeutic setting, this is typically followed by a boost with a second, different, viral vector encoded with the same antigen.
−Removed: This is known as a heterologous prime-boost approach.
+Added: Our platforms are designed to stimulate the production of very high levels of T cells, in addition to antibodies, against such antigens.
+Added: Our approach for the treatment or prevention of a disease with a known target antigen is to prime the immune system with an initial injection of a proprietary platform encoded with the target antigen.
+Added: In the therapeutic setting, this is typically followed by a boost with a second, different, platform encoded with the same antigen.
+Added: This is known as a heterologous prime-boost, or a mix and match approach.
We employ unique antigen design strategies to optimize immune presentation and maximize the desired type of antibody and/or T cell immunogenicity that we are seeking to induce.
This heterologous prime-boost approach has been shown to provide the highest magnitude and durable immunogenic CD8+ T cell response induced in humans to date.
−Removed: Our platform is further differentiated by its flexibility, applicability across diseases in both the therapeutic and prophylactic setting, favorable tolerability profile and proven rapid production on a large scale.
+Added: Our platforms are further differentiated by their flexibility, applicability across diseases in both the therapeutic and prophylactic setting, favorable tolerability profile and proven rapid production on a large scale.
+Added: Autoimmunity develops when the tolerance checkpoints meant to maintain a state of unresponsiveness of our immune system towards self-antigens are lost.
+Added: It results in abnormal immune reaction against our own tissues, causing tissue damage and disease.
+Added: Although the past two decades have seen incredible progress in the treatment of chronic inflammatory and autoimmune diseases, current therapies still rely heavily on the use of non-specific immunosuppressive agents and supportive therapies.
+Added: These may efficiently dampen inflammation and compensate organ dysfunction to some degree, but they require lifelong treatment and their lack of specificity for the pathogenic mechanism only can lead to several, sometimes life-threatening, side effects.
+Added: A far less aggressive approach is to restore immune tolerance to self-antigens, in an antigen-specific manner, enabling to selectively blunt autoinflammation and control the disease without impairing protective immunity to pathogens and cancer.
+Added: Our SNAPvax tolerizing platform is comprised of several self-antigens involved in the disease associated with a tolerizing immunomodulator.
+Added: It is specifically designed to induce self-antigen-specific regulatory T cells, whose main function is to control immune responses by means of direct cell-cell contact, release of soluble factors, or indirectly via antigen-presenting cells, thereby controlling hyperactive autoreactive pathogenic T cells specifically.
In 2022, we achieved a number of strategic, operational, and financial objectives, which we believe positions us to deliver on our long-term plans:
−Removed: ● In March, we raised $166.5 million of proceeds in a Series B private financing, including $41.2 million from previously issued convertible loan notes that converted into Series B shares.
−Removed: ● In May, we raised gross proceeds of $110.5 million from the initial public offering of our ordinary shares, represented by American Depositary Shares on Nasdaq.
−Removed: ● In July, we signed a clinical trial collaboration with Arbutus Biopharma to evaluate RNAi Therapeutic, AB-729, in combination with our immunotherapeutic, VTP-300, in patients with chronic HBV.
−Removed: ● In September, we signed a lease for 31,000 square feet within the Zeus development at the Harwell Science and Innovation Campus in Oxford, United Kingdom.
−Removed: The site will house the Company’s headquarters, state-of-the-art wet laboratory and offices.
−Removed: We anticipate completing the relocation by mid-2022.
−Removed: ● In October, we presented safety and immunogenicity data from Phase 1 and Phase 1/2a clinical trials at AASLD’s Liver Meeting.
−Removed: ● In November, we announced the publication of results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome, or MERS.
−Removed: The study, conducted by researchers at The King Abdullah International Medical Research Centre and Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.
−Removed: ● In November, we presented safety and immunogenicity data from the lead in portion of our ongoing HPV Phase 1/2a clinical trial at the International Papillomavirus Conference 2021.
−Removed: ● In December, we reported interim efficacy data from a Phase 1b/2a clinical trial in chronic HBV patients demonstrating greater than 1 log reduction in surface antigen at the three month timepoint in one of the cohorts.
−Removed: ● In December, we acquired Avidea Technologies, Inc., or Avidea, which expands our product pipeline, including autoimmune programs, adds scientific expertise, and brings complementary platform technologies to our arsenal.
−Removed: ● In December, the Cancer Research UK and the Ludwig Institute for Cancer Research initiated patient dosing in a Phase 1/2a clinical trial to test the safety and initial efficacy of VTP-600, an immunotherapeutic in development for the treatment of non-small cell lung cancer.
−Removed: The therapeutic candidate employs our viral vector prime-boost platform to deliver two cancer-associated proteins, MAGE-A3 and NY-ESO-1 to tumor cells.
−Removed: Strategic Transactions
−Removed: In December 2021, we acquired Avidea Technologies Inc.
−Removed: to expand both our technology base and product pipeline and to strengthen our scientific leadership in immunotherapies and vaccines.
−Removed: Prior to the acquisition, Avidea was a privately-held biotechnology company with a goal of advancing the next generation of safer and more effective T cell immunotherapies for treating cancer, infections, and autoimmune diseases.
−Removed: Avidea’s precision immunotherapies are enabled by polymer-drug conjugate technologies, which are purpose-built to address the need for improved T cell and antibody-based immunotherapies.
−Removed: Avidea has established current Good Manufacturing Practice, or cGMP, processes for its platforms and also achieved compelling in vivo proof-of-concept data in rigorous preclinical models for a number of product candidates.
−Removed: This has enabled a strong pipeline of immunotherapies, some of which we expect will enter clinical testing in 2022 and 2023.
−Removed: Avidea’s existing product candidates were developed using its SNAPvax platform.
−Removed: As reported in several recent high-profile publications, Nature Biotechnology and Nature Immunology , the SNAPvax platform is designed to use self-assembly to co-deliver multiple antigens and immunomodulators in nanoparticles of precise, programmable size and composition, thereby enabling immunotherapy product candidates with tighter control over immune responses.
−Removed: The SNAPvax platform can be configured either to induce high magnitude cytotoxic T cells for treating cancer and chronic infections or to induce regulatory T cells for treating autoimmunity and allergies.
−Removed: Within oncology, Avidea’s platform will expand our pool of target antigens and can be used to augment our heterologous prime-boost vaccines, which we believe will increase the probability of therapeutic success in this highly competitive area.
−Removed: The ability to induce antigen-specific regulatory CD4+ T cells with SNAPvax has the potential to broaden the range of therapeutic areas that we can pursue to include allergies and autoimmune diseases, each with significant market potential.
−Removed: The chart below provides key information about our programs.
−Removed: Our proprietary platform comprises several components that, when combined, allow us to develop product candidates designed to induce high and durable levels of antigen-specific T cells and B cells to prevent and treat infectious diseases and cancer.
−Removed: The key elements of our platform include our proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and an inability to replicate in humans.
+Added: ● In January, Cancer Research UK, Vaccitech and the Ludwig Institute for Cancer Research (Ludwig), announced the first patient dosed in the MAGE trial, which is testing a novel immunotherapeutic, VTP-600, in patients with the most common type of lung cancer.
+Added: ● In April, we announced the commencement of royalty payments relating to commercial sales of Vaxzevria.
+Added: The Company’s share of milestone and royalty payments received by OUI from AstraZeneca recognized as revenue for the year ended December 31, 2022, amounted to $43.7 million.
+Added: ● In April, the Company launched two programs utilizing our proprietary SNAPvax platform:
+Added: an immunostimulatory one to target HPV-associated cancer utilizing the SNAPvax platform and moved forward with a tolerizing one designed to induce regulatory T cells in patients with celiac disease.
+Added: IND applications are expected to be filed for VTP-1100, in HPV cancer, and VTP-1000, targeting celiac disease during the second half of 2023.
+Added: ● In April, we received scientific advice from the EMA defining a licensure pathway for the candidate MERS vaccine, VTP-500, which helps the Company to both plan and estimate expenses of the development pathway more accurately and completely.
+Added: ● In May, we completed enrollment for a Phase 1b/2a clinical trial, HBV002, to evaluate the safety and immunogenicity of VTP-300, both as monotherapy and in combination with an anti-PD-1 blocking agent, in patients with chronic Hepatitis B whose HBV infection has been suppressed with oral antiviral medication.
+Added: We expect to announce final topline data in the first quarter of 2023.
+Added: ● In June, Arbutus Biopharma Corporation (Arbutus) dosed the first patient in a randomized, multi-center, blinded, Phase 2a clinical trial to evaluate the safety, antiviral activity and immunogenicity of the combination of Arbutus’ RNAi therapeutic candidate, AB-729, with the Company’s T-cell stimulating immunotherapeutic, VTP-300, and standard-of-care nucelos(t)ide reverse transcriptase inhibitor therapy for the treatment of patients with virology-suppressed chronic HBV infection.
+Added: We expect to announce interim efficacy data in the fourth quarter of 2023.
+Added: ● In June, at the 2022 EASL International Liver Congress™, the Company presented HBV002 data showing that VTP-300, both as monotherapy and in combination with a single low dose of Nivolumab (PD1 blocker) at the time of the booster dose, induced sustained reductions of HBV surface antigen (HBsAg) in some patients, and a robust T cell response, of which CD8+ T cells were predominant, against all encoded antigens in patients with chronic HBV infection.
+Added: ● In June, the Company entered into a lease agreement for approximately 19,700 square feet in Germantown, Maryland.
+Added: The site will house the Company’s state-of-the-art wet laboratory and office space in the United States.
+Added: ● In July, the Company enrolled the 60th patient into the Company’s Phase 1b/2 clinical trial of VTP-200, HPV001, to evaluate a potential treatment for persistent high-risk HPV infection.
+Added: ● In July, we completed the relocation of our headquarters to Harwell, Oxfordshire, United Kingdom.
+Added: ● In August, the Company filed a Registration Statement on Form S-3, as amended, or the Shelf, with the Securities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million.
+Added: The Shelf was declared effective on August 17, 2022.
+Added: We also simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of $75.0 million of our ordinary shares represented by ADSs from time to time in “at-the-market” offerings under the Shelf.
+Added: As of December 31, 2022, we sold 307,139 ordinary shares represented by ADSs under the sales agreement, amounting to gross proceeds of $0.7 million.
+Added: ● In October, we announced the publication of research from VTP-1100 in Cell that demonstrated anti-tumor activity achieved with intravenous (IV) administration of a SNAPvax construct in an animal model.
+Added: The study demonstrated that IV administration of SNAPvax targeted and expanded antigen-specific T cells and reversed suppression in the tumor microenvironment, which promotes T cell infiltration and tumor cell killing.
+Added: ● In October, we announced the dosing of the first patient in HBV003, a Phase 2b clinical trial of VTP-300 designed to evaluate different regimens of low dose nivolumab and the impact of additional doses of the MVA boost, with the aim of maximizing a sustained decline in HBsAg.
+Added: ● In November, Dr.
+Added: Young-Suk Lim, Professor of Gastroenterology in the Liver Center at University of Ulsan College of Medicine, presented a poster reporting interim HBV0002 Phase 1b/2a clinical trial data on VTP-300 at AASLD.
+Added: The poster presentation showed VTP-300 immunotherapy, as monotherapy and when combined with low dose nivolumab at the boosting time point, was immunogenic and showed a sustained reduction in HBsAg in well-controlled CHB patients, and was administered with no treatment related SAEs and infrequent transient transaminitis.
+Added: Two of five patients dosed in cohort 3 (ChAdOx1-HBV + MVA-HBV with low dose nivolumab given at the boost) with starting HBsAg levels below 100 achieved non-detectable levels of surface antigen at the data cutoff.
+Added: ● In December, the FDA cleared our IND for VTP-850 to be evaluated in PCA001, a Phase 1/2 open-label clinical trial of in patients with rising PSA after definitive local therapy for prostate cancer.
+Added: We expect to announce the first patient dosed in the second quarter of 2023.
+Added: ● In December, the Company completed enrollment into the Phase 1b/2 clinical trial of VTP-200, HPV001, to evaluate a potential treatment for persistent high-risk HPV infection.
+Added: We expect to announce the full data from this trial in the first quarter of 2024.
+Added: Our Platforms
+Added: Our proprietary platforms comprise several components that either 1) when combined, allow us to develop product candidates designed to induce high and durable levels of antigen-specific T cells and B cells to prevent and treat infectious diseases and cancer, or 2) induce regulatory T cells and/or decrease T cell activation to specifically control autoreactive immune cell hyperactivity.
+Added: The key elements of our first platform include our proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and an inability to replicate in humans.
We believe both ChAdOx1 and MVA have favorable tolerability profiles, based on extensive clinical testing performed by us and others.
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In addition, our understanding and expertise in manufacturing optimization has allowed us to manipulate adenovirus genomes to enable rapid generation of recombinant adenoviral vectors at Good Manufacturing Practice, or GMP, standards at exceptional speed and significant scale.
−Removed: With the acquisition of Avidea, we have added SNAPvax to our proprietary platform.
−Removed: SNAPvax is a modular vaccine platform that is designed to leverage self-assembling nanoparticles to target multiple peptide antigens and immunomodulators to key immune cell populations for promoting T cell immunity.
−Removed: A recent article in Nature Biotechnology described SNAPvax as among the most efficient vaccine platforms for inducing T cell immunity reported to date.
+Added: With the acquisition of Avidea Technologies, Inc.
+Added: or Avidea, in December 2021, we have added SNAPvax to our proprietary platforms.
+Added: SNAPvax is a modular immunotherapy platform that is designed to leverage self-assembling nanoparticles containing multiple targeted peptide antigens and immunomodulators to key immune cell populations for promoting T cell immunity.
+Added: A recent article in Nature Biotechnology described SNAPvax as among the most effective immunotherapy platforms for inducing T cell immunity reported to date.
Another article in Nature Biotechnology reported that SNAPvax enables repeated intravenous, or IV, administration to maximize efficacy.
−Removed: Within oncology, we are advancing assets based on the SNAPvax cancer vaccine candidate, or SNAPvax CV, co-delivering tumor antigens and an immunostimulant (TLR-7/8a) for use in heterologous prime-boost regimens for treating advanced cancers.
−Removed: SNAPvax CV is designed to provide a unique advantage as compared to other cancer vaccine candidates as it can be repeatedly administered by the IV route to engage every stage of the cancer immunity cycle (T cell priming and expansion;
+Added: Within oncology, we are advancing assets based on the SNAPvax cancer immunotherapy platform, or SNAPvax CI, co-delivering tumor antigens and an immunostimulant (TLR7/8a) for use in heterologous prime-boost regimens for treating advanced cancers.
+Added: SNAPvax CI is designed to provide a unique advantage as compared to other cancer immunotherapy candidates as it can be repeatedly administered to engage every stage of the cancer immunity cycle (T cell priming and expansion;
tumor inflammation;
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and T cell licensing) to potentially maximize therapeutic benefit.
−Removed: Outside oncology, we are advancing assets based on the SNAPvax tolerance vaccine candidate, or SNAPvax TV, that targets autoantigens and immunomodulators ( e.g.
−Removed: , mTOR inhibitors) to specific immune cells for inducing regulatory T cells for treating autoimmunity.
−Removed: We have several therapeutic programs in our pipeline focusing on infectious diseases and oncology.
+Added: Outside oncology, we are advancing assets based on the SNAPvax tolerizing immunotherapy platform, or SNAPvax TI, to treat autoimmune diseases with known autoantigens.
+Added: SNAPvax TI contains autoantigens and immunomodulators ( e.g.
+Added: , mTOR inhibitors) to specifically induce regulatory T cells, crucial to maintaining tolerance to self-antigens.
+Added: Its unique design allows for trafficking to lymphoid organs and local tissues, where Treg induction occurs and their activity is required to maximize therapeutic benefit.
+Added: We have several therapeutic programs in our pipeline focusing on infectious diseases, oncology and immune tolerance.
+Added: The chart below provides key information about our programs.
An Immunotherapeutic Targeting Chronic HBV Infection
−Removed: We designed VTP-300 to enable a functional cure for patients with CHB, a life-threatening disease that affects an estimated 257 million people worldwide.
−Removed: VTP-300 is a novel immunotherapy candidate that we intend to administer in combination with a low-dose anti-PD-1 antibody to overcome the immune suppression and T cell exhaustion that results from CHB.
−Removed: We are currently conducting a Phase 1 safety and immunogenicity clinical trial in healthy volunteers and CHB patients.
−Removed: Interim data from two studies, a Phase 1 study investigating ChAdOx1-HBV alone in healthy volunteers and patients and a Phase 1/2a study in patients investigating a heterologous prime-boost regimen using ChAdOx-HBV and MVA-HBV, was announced in the fourth quarter of 2021.
−Removed: These data showed that, in CHB patients, VTP-300 induced robust T cells against targeted hepatitis B viral antigens.
−Removed: We expect to announce additional Phase 1/2a interim efficacy data at the International Liver Congress on June 22 to 26, 2022, followed by Phase 1/2a full efficacy clinical trial data in the second half of this year.
−Removed: In July 2021, we announced that we entered into a clinical trial collaboration agreement with Arbutus Biopharma Corporation, or Arbutus, to evaluate an innovative therapeutic combination for the treatment of patients with CHB infection who are already receiving standard-of-care nucleos(t)ide reverse transcriptase inhibitor, or NrtI, therapy.
−Removed: The multi-center, Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s proprietary GalNAc delivered RNAi therapeutic candidate, AB-729, followed by our proprietary immunotherapeutic candidate, VTP-300, in NrtI-suppressed patients with CHB.
−Removed: The Phase 2a clinical trial is expected to initiate in the first half of this year and will be sponsored by Arbutus, subject to oversight by a joint development committee composed of representatives from Arbutus and Vaccitech.
−Removed: The parties retain full rights to their respective product candidates and will split all costs associated with the clinical trial.
−Removed: Pursuant to the agreement, the parties intend to undertake a larger Phase 2b clinical trial depending on the results of the initial Phase 2a clinical trial.
+Added: In May 2022, we completed the last patient visit in our HBV001 Phase 1 clinical trial in the United Kingdom.
+Added: Two types of participants were enrolled:
+Added: healthy participants and participants with CHB whose infection has been suppressed with oral antiviral therapies.
+Added: The primary objective of the HBV001 trial is to evaluate the safety and tolerability of different doses of a single vaccination of ChAdOx1-HBV.
+Added: In addition, the secondary objectives are to determine the immunogenicity of ChAdOx1-HBV and to determine the effect of ChAdOx1-HBV on the level of HBsAg in the participants with chronic HBV infection.
+Added: All cohorts of healthy volunteers and patients with chronic HBV infection have completed treatment and follow up.
+Added: No serious adverse events have been reported as of the date of this report.
+Added: We have used genotype C HBV antigen sequences in our VTP-300 vectors to target the most prevalent CHB genotype.
+Added: However, we believe VTP-300 may induce cross-reactive T cell responses with other prevalent genotypes.
+Added: Therefore, we also aim to determine if the T cell responses induced by the ChAdOx1-HBV viral vector used in this trial can potentially cross-react with other common HBV genotypes.
+Added: The criteria for CHB patients to be enrolled in this trial were (i) infection that has been suppressed with oral antiviral medication (HBV DNA < 40 copies/mL) and (ii) relatively low levels of cccDNA markers (HBsAg < 10,000 IU/ml).
+Added: As higher levels of CD8+ T cell induction are likely to occur in healthy controls, these samples are utilized to map the responses induced by VTP-300, to assess cross-reactivity with peptides, representing consensus sequences from genotypes B and D, which are more common in both the United States and Europe.
+Added: In addition, we are conducting a Phase 1b/2a clinical trial, HBV002, to evaluate the safety and reactogenicity of VTP-300 with or without a low-dose (0.3 m/kg) anti-PD-1 in CHB patients whose infection has been suppressed with oral antiviral medication.
+Added: HBV002 enrollment was completed in May 2022.
+Added: In the HBV002 trial, we enrolled CHB patients in four treatment groups.
+Added: The primary objective of this trial is to determine the safety and reactogenicity of the following in participants with chronic HBV infection and virally suppressed with oral antiviral medication:
+Added: MVA-HBV (prime-boost);
+Added: ChAdOx1-HBV and MVA-HBV (prime-boost);
+Added: 3 and 4 ChAdOx1-HBV and MVA-HBV and nivolumab (prime-boost + anti-PD-1).
+Added: The secondary objectives are to evaluate immunogenicity, PD-1 blockade timing, and the effect on the levels of hepatitis B markers, including HBsAg, hepatitis B surface antibody seroconversion, hepatitis B DNA, HBeAg, in CHB patients.
+Added: The majority of the patients were recruited in Taiwan and South Korea and these territories were selected due to the high prevalence of HBV genotype C virus in Asia.
+Added: Patients were also enrolled in the United Kingdom.
+Added: Since the participants are already infected with HBV, we thought it was possible that natural priming could eliminate the need for the prime-boost regimen.
+Added: Hence, Group 1 of the HBV002 trial was designed to compare MVA-HBV given twice with the ChAdOx1-HBV plus MVA-HBV heterologous approach used in Group 2.
+Added: We expected that the regimen given to Group 2 would be more immunogenic and planned to further explore this prime/boost regimen in Groups 3 and 4.
+Added: The dosing regimen was ChAdOx1-HBV (day 0) and MVA-HBV and low-dose nivolumab (day 28) for Group 3 and ChAdOx1-HBV and low-dose nivolumab (day 0) and MVA-HBV and low-dose nivolumab (day 28) for Group 4.
+Added: In the cancer field, the use of an anti-PD-1 prior to vaccination has been reported to result in diminished T cell responses as compared to later administration.
+Added: Whether the anti-PD-1 can be given simultaneously with the priming dose, or should follow it, is yet to be determined.
+Added: Thus, in this protocol, we evaluated both regimens.
+Added: Group 3 employed the low dose nivolumab given only at the boost, whereas Group 4 administered the nivolumab at both the prime and the boost dose.
+Added: Nivolumab has been used in earlier immunotherapy trials at 1/10 the licensed dose for oncology indications and has been shown to give full peripheral blood T cell receptor occupancy for up to over one month.
+Added: An interim analysis of HBV002 was conducted in November 2021, after which the protocol was amended to stop enrollment in two cohorts:
+Added: those receiving MVA prime and boost, Group 1, and those receiving VTP-300 with low dose nivolumab administered with both the ChAdOx1 prime and the MVA booster dose, Group 4.
+Added: Enrollment continued in the cohort receiving VTP-300 as a monotherapy and the cohort receiving VTP-300 with a single low dose of nivolumab administered with the MVA booster dose.
+Added: We believe that the interim analysis from the HBV002 Phase 1b/2a suggests that VTP-300 could become part of a regimen that can attain a functional cure.
+Added: In October 2022, we dosed our first patient in HBV003, a Phase 2b clinical trial to explore the optimal regimen.
+Added: Although VTP-300 encodes genotype C antigens, many of these peptides are also expressed by other HBV genotypes.
+Added: Our data indicate that VTP-300 is capable of inducing responses to non-genotype C HBVs, so we will aim to demonstrate activity against non-genotype C infected patients.
+Added: We will also plan to evaluate additional combination regimens, such as next-generation modalities including RNA interference molecules, and may evaluate further potential collaboration partnerships.
+Added: We may also evaluate VTP-300 in a trial in mainland China.
+Added: EASL and AASLD Poster Update to Interim Analysis of Safety and Efficacy Data from HBV002 Study
+Added: On June 22, 2022, we announced an update to the interim analysis of safety and efficacy data from the HBV002 study (NCT04778904), which was presented as a poster at the 2022 EASL International Liver Congress TM.
+Added: The updated analysis, which included 39 patients with three-months of follow up, showed that VTP-300 as a monotherapy or in combination with low-dose nivolumab was administered with no treatment-related serious adverse events and that two patients experienced mild, rapidly resolving transaminitis.
+Added: Meaningful and durable reductions of HBsAg were seen in some patients who received VTP-300 as either a monotherapy or in combination with a single low dose of nivolumab at the time of booster dose.
+Added: Declines were most prominent in patients with lower baseline HBsAg at the time of enrollment.
+Added: In all patients who had a HBsAg decline greater than 0.5 log10, the reductions of HBsAg were durable until the last measurement (up to eight months after the last dose).
+Added: A robust T cell response against all encoded antigens, measured by overnight stimulation, was observed following VTP-300 administration, notable for marked CD8+ T cell predominance.
+Added: Enrollment in the HBV002 study is complete with 55 patients enrolled.
+Added: On November 7, 2022, we announced an update to the interim analysis of safety and efficacy data from the HBV002 study (NCT04778904), which was presented as a poster at the 2022 American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® by Dr.
+Added: Young-Suk Lim, Professor of the Department of Gastroenterology and the Liver Center, Asian Medical Center, University of Ulsan College of Medicine, Korea.
+Added: The updated analysis, which included 55 patients with three months of follow up, showed that VTP-300 induced meaningful, sustained reductions of HBV surface antigen (HBsAg) in people with chronic HBV.
+Added: Declines were most prominent in patients with lower baseline HBsAg.
+Added: HBsAg is a hallmark of chronic HBV infection.
+Added: Fewer than 10% of patients on current standard-of-care HBV therapies achieve sustained HBsAg decrease or loss, a state associated with functional cure of the disease.
+Added: Group 3 (N=18) patients received VTP-300 in combination with a single low dose of nivolumab at the time of the booster dose, and the mean log10 reduction in HBsAg was 0.8 (n=18) at 3 months, 0.9 (n=10) at 6 months, and 1.3 (n=7) at 9 months, with more prominent declines observed in patients with baseline HBsAg lower than 1,000 IU/mL.
+Added: Five patients in this group had baseline HBsAg lower than 100 IU/mL, of which four had declines over 0.6 log10.
+Added: Moreover, two of those patients developed non-detectable HBsAg at 3 months, and one of the patients, who has been evaluated at 6 and 9 months, continued to maintain non-detectable HBsAg.
+Added: Future Development
+Added: In October 2022, the Company dosed the first patient in HBV003, a Phase 2b clinical trial of VTP-300 (NCT05343481) to explore the impact of different regimens of low dose Nivolumab and additional doses of the MVA boost component of VTP-300.
+Added: In addition, a trial that uses a lead-in of the Arbutus siRNA AB-729, followed by a blinded randomization to either placebo or VTP-300, is now underway under Arbutus sponsorship with a planned enrollment of 20 patients per arm (placebo vs VTP-300 after the 6 month siRNA lead-in).
+Added: The trial also plans a prospective, well-defined, nucleotide discontinuation protocol for those patients who reach substantial reduction in the level of hepatitis B surface antigen.
+Added: We expect to announce interim efficacy data from both the HBV003 study and the combination study with siRNA from Arbutus in the fourth quarter of 2023.
Developing a Potential Non-Invasive Treatment for Persistent High-Risk HPV
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An estimated 291 million women worldwide are carriers of HPV DNA, which can progress to pre-cancerous cervical lesions if untreated.
−Removed: We are currently enrolling patients in a Phase 1/2a clinical trial of VTP-200 in Europe and the UK with last patient, first visit anticipated in the second quarter of 2022, and a planned interim analysis is expected to be available in the fourth quarter of 2022.
+Added: Enrollment in our Phase 1b/2 clinical trial of VTP-200, HPV001 (NCT04607850), was completed in December 2022.
+Added: Preclinical Studies
+Added: Extensive preclinical studies were conducted using VTP-200, with resulting data showing that:
+Added: VTP-200 was well tolerated in preclinical toxicology studies;
+Added: VTP-200 was highly immunogenic in inbred and outbred mice.
+Added: Toxicology Studies
+Added: In a GLP-compliant toxicology study, outbred mice were dosed with ChAdOx1-HPV and MVA-HPV at dose levels approximating the maximum anticipated clinical dose.
+Added: Dosing resulted in an immune response, but with no significant toxicology findings.
+Added: Immunogenicity Studies
+Added: In preclinical immunogenicity studies, the HPV antigen was delivered by plasmid DNA, ChAdOx1 and MVA vectors in prime-boost regimens to inbred and outbred mice.
+Added: ChAdOx1-HPV prime followed by MVA-HPV boost was shown to induce higher magnitude and more durable HPV-specific T cell responses than other regimens, as shown in the figure below.
+Added: VTP-200-induced T cells were polyfunctional and persisted at high frequencies for at least six weeks.
+Added: In the preclinical immunogenicity studies, HPV-specific effector CD8+ T cells were detected in the cervix following systemic administration of ChAdOx1-HPV prime and followed by MVA-HPV boost.
+Added: Finally, T cells specific for the HPV-encoded antigens were detected in women with current or past hrHPV infections, confirming the presence of immunogens relevant to natural immune control.
+Added: The MVA vector assessed in initial studies contains the HPV antigen at the thymidine kinase locus under the control of the p7.5 promoter.
+Added: However, a more immunogenic MVA vector, which contains the HPV antigen under the control of the endogenous F11 promoter, was constructed.
+Added: We determined that the T cell immunogenicity of the more immunogenic MVA promoter was superior to the MVA vector assessed in the initial preclinical studies and decided to use the next-generation vector in our clinical trials.
+Added: Clinical Development
+Added: Our HPV001 Phase 1b/2 clinical trial of VTP-200 was designed to assess the safety and efficacy of VTP-200 and determine the optimal immunotherapeutic dose regimen.
+Added: We enrolled a total of 108 healthy women with low grade lesions who had persistent high-risk HPV, or hrHPV, for at least six months.
+Added: Patients with high-grade squamous intraepithelial lesions, or HSIL, or early cancer were excluded.
+Added: The trial was run in the United Kingdom and the European Union.
+Added: We recently announced the topline initial interim immunogenicity and safety data of 58 patients in the main phase of the trial that reached their six-month evaluation timepoint.
+Added: We expect to announce full data from this trial in the first quarter of 2024.
+Added: The diagram below provides an overview of the Phase 1b/2 clinical trial design.
+Added: The HPV001 Phase 1b/2 clinical trial was designed to identify an efficacious dose based on a joint response index of CD8+ T cell magnitude, CD4+T cell magnitude and CD4+ T cell avidity.
+Added: The primary objective of the trial was to evaluate the safety and tolerability of ChAdOx1-HPV plus MVA-HPV when administered in a prime-boost regimen.
+Added: The secondary objectives of the trial were to determine the optimal dose and to evaluate the efficacy of HPV001 on the clearance of hrHPV infection and on the cervical intraepithelial neoplasia, or CIN.
+Added: Future Development
+Added: Following the HPV001 Phase 1b/2 clinical trial, if successful, we intend to initiate further clinical trials of VTP-200.
+Added: Our next trials would potentially be a Phase 2/3 trial in healthy women with early grade CIN (squamous intraepithelial lesions, or LSIL) and additional trials in patients with more advanced CIN, vulval intraepithelial neoplasia, or VIN, and anal intraepithelial neoplasia, or AIN.
+Added: We are also in the early stages of collaborating on an NIH-funded trial that would be conducted by the University of California San Francisco in more advanced CIN and AIN in human immunodeficiency virus, or HIV, positive patients, to be recruited in Mexico and Puerto Rico.
Our Next-Generation Immunotherapeutic Candidate for Prostate Cancer
−Removed: We are developing our next-generation immunotherapy candidate, VTP-850, as a treatment for castration sensitive nonmetastatic prostate cancer.
−Removed: Prostate cancer is the fifth leading cause of cancer-related death in men worldwide.
−Removed: VTP-850 builds on the positive data from a Phase 1/2a clinical trial of VTP-800, our first generation product candidate which encodes 5T4, an antigen expressed by most prostate cancers.
−Removed: VTP-800 has been administered to patients with prostate cancer in two clinical trials sponsored by the University of Oxford.
−Removed: We are developing VTP-850 with the goal of inducing a broader immune response by targeting 5T4 plus additional important antigens expressed by prostate cancer cells.
−Removed: We plan to start a Phase 1/2 clinical trial of VTP-850 in the third quarter of 2022.
+Added: We are developing VTP-850, our next-generation prostate cancer product candidate, to improve upon VTP-800.
+Added: Both VTP-800 and VTP-850 are composed of a heterologous prime-boost regimen with ChAdOx1 prime and MVA boost;
+Added: however, VTP-800 encodes only one antigen, 5T4, while VTP-850 encodes four antigens, PSA, PAP, STEAP1 and 5T4.
+Added: We designed VTP-850 to induce a broader immune response by encoding multiple antigens to reduce the ability of cancer cells to evade the immune response by mutating or losing expression of any one antigen.
+Added: The antigens we encode in VTP-850 are expressed in most prostate cancers but have little or no expression on healthy tissues other than prostate.
+Added: Clinical Development
+Added: Phase 1 and Phase 2 clinical trials of VTP-800 were sponsored and conducted by the University of Oxford in the United Kingdom.
+Added: VANCE was a first-in-human, open-label, randomized, Phase 1 clinical trial designed to evaluate the safety and immunogenicity of heterologous prime-boost ChAdOx1-MVA administration as compared with homologous prime-boost with MVA alone, with and without low dose cyclophosphamide in localized prostate cancer.
+Added: Thirty-nine patients with early stage localized, castration-sensitive prostate cancer were treated.
+Added: Thirty-three patients received heterologous prime-boost with ChAdOx1-5T4 and MVA-5T4, while six patients received homologous prime-boost with MVA-5T4 alone.
+Added: Patients received both regimens alone or with cyclophosphamide preconditioning.
+Added: VTP-800 was generally well tolerated, with side effects of local injection site pain, fatigue, feverishness, and myalgia, which are consistent with those observed for these vectors in other clinical trials.
+Added: There were no reported treatment-related serious adverse events.
+Added: It was also observed that 59% of participants had no detectable T cell response at baseline and developed a new 5T4-specific T cell response, as measured by an ex vivo gamma interferon ELISpot.
+Added: Two patients had a baseline response, and the frequency of 5T4-specific T cells was increased following administration.
+Added: The mean peak response of the 5T4-specific T cells in the responders was 198 cells per one million PBMCs, which is notable given that the 5T4 is a self-antigen.
+Added: T cell infiltration into the resected prostate was also observed.
+Added: The figure below shows the 5T4-specific T cell responses to VTP-800 in the responding patients.
+Added: The peak response, expressed as the number of 5T4-specific T cells secreting IFN-γ per one million PBMCs, in each patient who mounted a 5T4-specific T cell response following administration was compared to the 5T4 response detected prior to the first dose.
+Added: The bars represent medians.
+Added: T Cell Response in Patients
+Added: ADVANCE was an open-label, non-randomized Phase 2 clinical trial of VTP-800 in combination with anti-PD-1 checkpoint inhibitor, nivolumab, in 23 patients with metastatic prostate cancer.
+Added: The primary objectives of the ADVANCE trial were to assess the safety and response rate of VTP-800 when administered in combination with nivolumab.
+Added: The secondary objectives were to assess the immune responses in peripheral blood and to evaluate radiographic progression-free survival and overall survival.
+Added: Patients received ChAdOx1-5T4 prime and MVA-5T4 boost one month later.
+Added: Nivolumab was administered at months one, two and three.
+Added: In most patients, VTP-800 was also given at months three and four.
+Added: All patients received 2.5 x 10˄10 vp of ChAdOx1-5T4, 2.0 x 10˄10 pfu of MVA-5T4 and 480mg of nivolumab.
+Added: VTP-800 was generally well tolerated.
+Added: The most common treatment emergent adverse events were bone pain, injection site pain, muscle pain, stomatitis, and constipation, and most were mild and grade 1 or 2.
+Added: The only grade 3 adverse event was a chest infection, which was not related to study drug.
+Added: There were no grade 4 or 5 treatment-related adverse events.
+Added: Three of eight patients with measurable disease had partial tumor responses.
+Added: Five of 23, or 22%, of patients had greater than 50% reduction of prostate specific antigen, or PSA, at any timepoint, as shown in the figure below.
+Added: PSA Reduction in Patients
+Added: Future Development
+Added: The FDA accepted our IND for VTP-850 to be evaluated in PCA001, a Phase 1/2 open-label clinical trial in patients with rising PSA after definitive local therapy for prostate cancer, commencing in the first quarter of 2023.
+Added: We plan to conduct the trial in several countries, including the United States.
+Added: The trial will involve a Phase 1 dose finding stage with boost dose administered either intramuscularly or intravenously to determine the Phase 2 recommended dose and route of administration, followed by a two-stage expansion phase to evaluate immunogenicity and anti-tumor activity of VTP-850.
+Added: Our first product utilizing SNAPvax CI platform for HPV16+ cancers
+Added: VTP-1100 is our first product candidate leveraging the SNAPvax platform technology – brought into Vaccitech following the acquisition of Avidea in December 2021 – that will enter clinical testing.
+Added: VTP-1100 differs from VTP-200 in composition and patient population targeted:
+Added: VTP-1100 will use a configuration of SNAPvax that is designed to elicit antigen-specific CD8+ T cells against HPV16+ cancers, either when administered alone or when used in a potent heterologous prime-boost regimen with the established ChAdOx1 platform.
+Added: Preclinical studies in mice have shown that the SNAPvax-ChAdOx prime-boost induced superior T cell responses as compared with single or dual agent therapies (see figure below).
+Added: Status and Future Development
+Added: VTP-1100 is currently in the preclinical stage with GMP manufacturing and pivotal IND-enabling studies underway.
+Added: We received pre-IND feedback from the FDA in July 2022, and based on the agency’s feedback expect to file an IND in the second half of 2023.
+Added: Antigen-specific tolerizing immunotherapy candidate for celiac disease
+Added: Patients with celiac disease have an unwanted immune response against gluten proteins and can become severely ill following exposure to gluten found in various cereal grains, especially wheat.
+Added: VTP-1000 is a tolerizing immunotherapy that is designed to induce antigen-specific regulatory T cells (Tregs) that promote tolerance and suppress the unwanted immune response to gluten.
+Added: VTP-1000 is the second product candidate based on the SNAPvax platform, designed to leverage its plug-and-play modularity to induce an entirely different type of T cell compared to the configuration utilized in VTP-1100.
+Added: VTP-1000 comprises multiple gluten antigens (representing the key epitopes linked to celiac disease) and an immunomodulator co-delivered in nanoparticles of precise size and composition that are optimized to target immune cells that prime and expand Tregs.
+Added: While the SNAPvax tolerizing immunotherapy is based on the same platform technology as the SNAPvax cancer immunotherapy enabling VTP-1100, an important distinction is that the tolerance immunotherapy includes an immunosuppressive immunomodulator that drives Treg expansion and prevents proinflammatory responses.
+Added: Status and Future Development
+Added: VTP-1000 is currently in preclinical development.
+Added: Preclinical lead optimization studies were recently completed and the product is entering engineering manufacturing, which we expect will enable us to enter first-in-human testing in a dose-escalation and challenge study by the end of 2023, pending submission and FDA clearance of an IND.
+Added: Vaccitech plans to include pharmacodynamic analysis as part of the Phase 1 study to provide an indication that the immunotherapy is inducing Tregs.
+Added: Importantly, Vaccitech also intends to include a controlled gluten challenge in the Phase 1 study (for example, see Goel G, et al.
+Added: Science Advances (2019) Cytokine release and gastrointestinal symptoms after gluten challenge in celiac disease).
+Added: This controlled gluten challenge is intended to provide an early biologic signal that VTP-1000 suppresses pathological response to gluten ingestion.
+Added: As VTP-1000 is our first product candidate directed towards the treatment of an inflammatory disease, we believe demonstration of Treg induction and/or suppression of unwanted immune responses to gluten would pave the way for other therapies based on the SNAPvax tolerizing immunotherapy platform, including those for allergies and other autoimmune indications.
Our Immunotherapeutic Candidate Targeting MAGE-A3 and NY-ESO1 Antigens
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There are an estimated 140 million cases globally of shingles each year, which can result in significant post-infection pain, known as post-herpetic neuralgia, or even death.
−Removed: Our regional partner in China and Southeast Asia, CanSino, plans to initiate a Phase 1 clinical trial of VTP-400 for shingles prevention in China.
−Removed: A Vaccine Candidate to Prevent MERS
+Added: Our regional partner in China and Southeast Asia, CanSino, plans to initiate a Phase 1 clinical trial of VTP-400 for shingles prevention.
+Added: A Prophylactic Vaccine Candidate to Prevent MERS
We are developing VTP-500 as a vaccine product candidate to prevent infection and subsequent disease caused by the MERS coronavirus.
Although human-to-human transmission appears to be rare, MERS coronavirus has the potential to cause epidemics, infecting hundreds of thousands of people and causing significant morbidity and mortality in 34% of infected individuals.
−Removed: Clinical efficacy trials to prevent MERS are challenging to execute due to the sporadic nature of infection, however studies have demonstrated positive Phase 1 safety and immunogenicity data.
+Added: Clinical efficacy trials to prevent MERS are challenging to execute due to the sporadic nature of infection, however studies have demonstrated positive Phase 1 safety and immunogenicity infections data.
In November 2021, VTP-500 results from the Saudi Arabia Phase 1 study were published in The Lancet Microbe .
−Removed: The Phase 1 data showed that VTP-500 was generally well tolerated in patients, and we plan to continue further development of the product candidate.
−Removed: Vaxzevria (formerly AZD1222):
−Removed: Prophylactic Vaccine for the Prevention of COVID-19 Infection
+Added: The Phase 1 data showed that VTP-500 was generally well tolerated in patients, and further development of the product candidate is planned by our non-exclusive licensee, the University of Oxford.
+Added: A Prophylactic Vaccine for the Prevention of COVID-19 Infection
We believe our platform also positions us to develop vaccines rapidly to address epidemic and pandemic threats, as demonstrated by the speed of the initiation of clinical trials of Vaxzevria (formerly VTP-900 and AZD1222) for the prevention of COVID-19, which entered the clinic within three months from initial antigen design.
We co-invented our first-generation COVID-19 vaccine candidate VTP-900, now Vaxzevria, in partnership with the University of Oxford’s Jenner Institute, which we assigned to OUI to facilitate the licensing of those rights by OUI to AstraZeneca.
−Removed: Vaxzevria, which is currently in Phase 3 clinical trials, uses our first-generation vector, ChAdOx1, and encodes the SARS-CoV-2 spike protein.
+Added: Vaxzevria, uses the ChAdOx1 vector, and encodes the SARS-CoV2 spike protein.
On June 28, 2021, a sub-analysis from the Oxford-led COV001 and COV002 trials showed that Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose.
8 unchanged sentences
It also has Emergency Use Listing from the World Health Organization, which accelerates the pathway to access in up to 144 countries through the COVAX Facility.
−Removed: As of February 10, 2022, more than 2.5 billion doses of Vaxzevria have been supplied across more than 170 countries globally.
+Added: As of November 1, 2022, more than 3 billion doses of Vaxzevria have been supplied across 180 countries globally.
+Added: It has been estimated that over 6 million lives have been saved worldwide, and between 37.7 and 122.4 million hospitalizations were prevented.
We are eligible to receive a share of royalties and other revenue received by OUI pursuant to its agreement with AstraZeneca for Vaxzevria.
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Our platform uses technologies that were developed at the Jenner Institute over 15 years and through clinical trials involving thousands of participants.
−Removed: Our scientific founders, Professor Adrian Hill and Professor Sarah Gilbert, are leaders in the fields of infectious diseases, immunology, vaccine development and viral vectors.
+Added: Our scientific founders, Professor Adrian Hill KBE, FRCP, FRS and Professor Dame Sarah Gilbert DBE, are leaders in the fields of infectious diseases, immunology, vaccine development and viral vectors.
Professor Hill is the founding Director of the Jenner Institute at the University of Oxford and is also the Lakshmi Mittal and Family Professor of Vaccinology at the University of Oxford.
Professor Gilbert is Professor of Vaccinology at the University of Oxford and leads programs on the development of vaccines against multiple emerging viral pathogens as well as research into vaccine manufacturing.
−Removed: She is the Oxford Project Lead for the Oxford/AstraZeneca COVID-19 vaccine project.
+Added: She was the Oxford Project Lead for the Oxford/AstraZeneca COVID-19 vaccine project.
We have assembled a management team with extensive expertise in building and operating biopharmaceutical organizations that have discovered, developed and delivered innovative medicines to patients.
Our management team has broad experience and successful track records in biopharmaceutical research, clinical development, regulatory affairs, manufacturing and commercialization, as well as in business, operations, and finance.
−Removed: Our management team’s experience was gained at leading institutions that include Aeras,
−Removed: Agalimmune, Altimmune, Aptiv Solutions, Exscientia, GenVec, Goldman Sachs, Kite Pharma, Pfizer, Novartis, PsiOxus, UBS and Vical.
+Added: Our management team’s experience was gained at leading institutions that include Agalimmune, Akamis Bio, Altimmune, Aptiv Solutions, Ernst & Young, GenVec, IAVI, Kite Pharma, Pfizer, Merck-Serono, Novartis and Roche.
Our board of directors has extensive expertise in the fields of science, business and finance.
Our scientific advisory board, or SAB, works with our management team in the planning and development of scientific, clinical, and research and development initiatives and strategies.
−Removed: The SAB is composed of scientific and clinical thought leaders in the fields of vaccine development, immunology, infectious diseases and oncology.
+Added: The SAB is composed of scientific and clinical thought leaders in the fields of immunotherapy, vaccine development, immunology, infectious diseases, immunotolerance and oncology.
The Key Elements of Our Platform
−Removed: Our proprietary platform comprises several components that, when combined, allow us to develop product candidates designed to induce high and durable levels of antigen-specific T cells and B cells to prevent and treat infectious diseases and cancer while maintaining the desired tolerability profile.
−Removed: Our platform generates excellent immunogenicity in terms of B cell and T cell responses and is differentiated by its ability to induce very high numbers of functional and durable CD8+ T cells.
−Removed: The key elements of our platform are:
+Added: Our proprietary platforms comprise several components that either 1) when combined, allow us to develop product candidates designed to induce high and durable levels of antigen-specific T cells and B cells to prevent and treat infectious diseases and, cancer or 2) in the case of SNAPvax, induce regulatory T cells and/or decrease T cell activation to specifically control autoreactive immune cell hyperactivity, while maintaining the desired tolerability profile.
+Added: Our immunostimulatory platforms generate excellent immunogenicity in terms of B cell and T cell responses and are differentiated by their ability to induce very high numbers of functional and durable CD8+ T cells.
+Added: Our tolerizing platform is designed to restore immune tolerance by a mechanism of action, which includes the induction of regulatory T cells.
+Added: The key elements of our platforms are:
● Proprietary Simian Vectors:
15 unchanged sentences
● Antigen Selection and Design:
−Removed: We select full-length and subunit antigenic sequences from target pathogens, autoimmune targets or cancers.
+Added: We select full-length and subunit antigenic sequences from targeted pathogens, autoimmune targets or cancer targets.
We employ unique antigen design strategies to optimize in vivo immune presentation and maximize the desired type of immunogenicity while maintaining the desired tolerability profile.
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We believe our sequencing techniques have the potential to result in safer, more stable, product candidates.
−Removed: Our adenovirus product candidates can be manufactured at exceptional speed and to significant scale, as it has been demonstrated with the COVID-19 vaccine candidate AZD1222.
−Removed: AZD1222, which is based on the ChAdOx1 vector, was designed, constructed and manufactured for human use within three months.
+Added: Our adenovirus product candidates can be manufactured at exceptional speed and to significant scale, as it has been demonstrated with the COVID-19 vaccine Vaxzevria.
+Added: Vaxzevria, which is based on the ChAdOx1 vector, was designed, constructed and manufactured for human use within three months.
Normal GMP production processes typically take six to ten months each for adenovirus and for MVA.
1 unchanged sentence
This platform allows for small molecules, such as Toll-like receptor agonists or inducers of T regulatory cells, to be co-delivered to the target cells.
−Removed: The platform has induced high magnitude, functional CD8+ T cells, especially when given as part of a prime-boost combination with ChAdOx1 in preclinical studies in mice and non-human primates.
+Added: The immunostimulatory SNAPvax platform has induced high magnitude, functional CD8+ T cells, especially when given as part of a prime-boost combination with ChAdOx1 in preclinical studies in mice and non-human primates.
+Added: The tolerizing SNAPvax platform has shown promising data on protection from disease in a mouse model of autoimmunity.
The products can be delivered by either the intramuscular or intravenous route, can modify innate immune function, and can be given repeatedly.
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If we sublicense the Licensed Technology, we will be required to pay OUI a mid-single-digit royalty on any royalties paid to us by the sublicensee and a high single-digit royalty on non-royalty sublicensing income (excluding milestone payment income overlapping with milestone payments paid to OUI and income used to fund research and development).
−Removed: As of December 31, 2021, we had paid OUI £18,750 in royalties under the 2016 OUI License Agreement.
In the event that the royalties (excluding the royalty on sublicensing income) owed to OUI do not amount to a specified minimum ranging from the mid five figures to low six figures based on the license year in each year following March 2020, we must also pay OUI the difference between the royalty paid and the applicable minimum sum payable.
6 unchanged sentences
OUI may terminate the agreement upon us filing for bankruptcy or in the event of liquidation or receivership proceedings, or upon 30 days’ prior written notice upon the occurrence of certain other events.
−Removed: Upon termination of the 2016 OUI License Agreement, we are
−Removed: required to, among other things, grant to OUI an irrevocable, transferable, non-exclusive license to develop, make and use any improvements to the Licensed Technology which we made prior to the second anniversary of the date of the agreement.
+Added: Upon termination of the 2016 OUI License Agreement, we are required to, among other things, grant to OUI an irrevocable, transferable, non-exclusive license to develop, make and use any improvements to the Licensed Technology which we made prior to the second anniversary of the date of the agreement.
2017 License Agreement with OUI
−Removed: In September 2017, we entered into a further license agreement with OUI, or the 2017 OUI License Agreement, for the development and commercialization of vaccines for HBV and HPV.
−Removed: Pursuant to the 2017 OUI License Agreement, we acquired a worldwide license under certain additional patent rights of OUI, including rights related to the use of HBV vaccine product candidates, HPV vaccine product candidates and shark invariant chain polypeptides, among other rights, or the 2017 Licensed Technology, to develop, manufacture, use and commercialize licensed products.
+Added: In September 2017, we entered into a further license agreement with OUI, or the 2017 OUI License Agreement, for the development and commercialization of immunotherapies for HBV and HPV.
+Added: Pursuant to the 2017 OUI License Agreement, we acquired a worldwide license under certain additional patent rights of OUI, including rights related to the use of HBV immunotherapy product candidates, HPV immunotherapy product candidates and shark invariant chain polypeptides, among other rights, or the 2017 Licensed Technology, to develop, manufacture, use and commercialize licensed products.
The rights are exclusive in some fields and non-exclusive in others.
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Upon termination of the 2017 OUI License Agreement, we are required to, among other things, grant to OUI an irrevocable, transferable, non-exclusive license to develop, make and use any improvements to the Licensed Technology which we made prior to the second anniversary of the date of the agreement.
+Added: 2017 License Agreement with OUI (Vaccitech North America, Inc.)
+Added: In March 2017, Avidea Technologies Corporation (“Avidea”) entered into a license agreement with OUI for the development and commercialization of products comprising thermo-responsive adjuvant scaffolds for use in all indications.
+Added: All of Avidea’s rights, duties and obligations under the 2017 OUI License Agreement were assumed by Vaccitech North America, Inc.
+Added: (“Vaccitech NA”) following the acquisition of Avidea by Vaccitech plc.
+Added: on December 10, 2021.
+Added: Pursuant to the 2017 OUI License Agreement, OUI granted us a worldwide license under certain patent rights of OUI related to the use of thermo-responsive adjuvant scaffolds, among other rights, or the Licensed Technology, to develop, manufacture, use and commercialize licensed products.
+Added: The license to patent rights are exclusive in all fields, and the license to know how is non-exclusive.
+Added: The Licensed Technology is sublicensable subject to obtaining OUI’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed) and inclusion in any sublicense agreement of restrictions on further sub-licensing, among other terms and conditions.
+Added: Pursuant to the 2017 OUI License Agreement, all intellectual property rights resulting from improvements made by us belong to us.
+Added: OUI retains the right for the University of Oxford, the U.S.
+Added: National Institutes of Allergy and Infectious Diseases (“NIAID”), the Instutite of Macromolecular Chemistry of the Czech Republic (“IMC”) and any person who works or has worked on the Licensed Technology to use the Licensed Technology and any licensee improvements for non-commercial use.
+Added: Furthermore, the University of Oxford, NIAID or IMC may publish the Licensed Technology and those improvements without our consent provided that they have first given us advance notice and delayed the publication if necessary for us to obtain patent protection.
+Added: In addition, OUI retains the right to grant academic and research licenses to any third parties under the Licensed Technology to encourage basic research for education and limited clinical patient care but may not grant licenses for commercialization of the Licensed Technology that is exclusively licensed to us, nor for development or marketing or products or services that are produced or supplied using the Licensed Technology.
+Added: Upon execution of the 2017 OUI License Agreement, we paid OUI a one-time upfront fee of £3,000.
+Added: We are obligated to pay OUI a low single-digit royalty on net sales of any product or process produced by or using the Licensed Technology.
+Added: If we sublicense the
+Added: Licensed Technology, we will be required to pay OUI a mid-single-digit royalty on any non-royalty sublicensing income.
+Added: As of March 23, 2023, OUI has not been paid any royalties under the 2017 OUI License Agreement.
+Added: In the event that the royalties (excluding the royalty on sublicensing income) owed to OUI do not amount to a specified minimum ranging from the low to mid five figures based on the license year in each year following March 2020, the licensee must also pay OUI the difference between the royalty paid and the applicable minimum sum payable.
+Added: In March 2021 £10,000 was paid to OUI, being the difference between royalties paid and the minimum sum payable.
+Added: In March 2023 £40,000 was paid to OUI, being the difference between royalties paid and the minimum sum payable.
+Added: In addition, we are required to pay OUI milestone payments of up to an aggregate of £2.43 million upon the achievement of specified development, regulatory and commercial milestones.
+Added: Unless earlier terminated, the 2017 OUI License Agreement will continue for as long as anything within the definition of the licensed patent remains in effect or 20 years from the date of the agreement.
+Added: The patent licensed under the 2017 OUI License Agreement, if granted, is expected to expire in October 2035, without giving effect to any potential patent term extensions or patent term adjustments.
+Added: Either party may terminate for the uncured breach of the other party.
+Added: We may terminate the agreement at any time upon six months’ prior written notice.
+Added: OUI may terminate the agreement upon us filing for bankruptcy or in the event of liquidation or receivership proceedings, or upon 30 days’ prior written notice upon the occurrence of certain other events.
+Added: Upon termination of the 2017 OUI License Agreement, we are required to, among other things, grant to OUI an irrevocable, transferable, non-exclusive license to develop, make and use any improvements to the Licensed Technology which we made prior to the second anniversary of the date of the agreement.
+Added: 2017 Cooperative Research and Development Agreement with NIH (Vaccitech North America, Inc.)
+Added: In February 2017, Avidea entered into a Cooperative Research and Development Agreement (“CRADA”) with the U.S.
+Added: National Institutes of Health (“NIH”) to carry out collaborative research for the evaluation of Avidea’s synthetic, polymer-based vaccine technology, “Immunotherapeutic Nanoscaffolds” (IMNs) for infectious disease prevention and cancer treatment in animal models.
+Added: Under this CRADA Avidea committed to providing scientific staff together with materials for use in experiments to evaluate their performance in various animal models of infectious disease and cancer.
+Added: Under this CRADA NIH committed to evaluating Avidea materials in animal models and to perform comprehensive immune analysis.
+Added: No funding was exchanged under this CRADA.
+Added: In October 2019, the CRADA was amended (“1st CRADA Amendment”) to expand the scope of the collaborative research to evaluate the therapeutic potential of Avidea’s polymer-based vaccine technology, “Immunotherapeutic Nanoscaffolds” (IMNs), including Star polymers and self-assembling nanoparticles based on amphiphilic polymers (SNAP), in preclinical animal models for cancer, infectious and inflammatory diseases.
+Added: Under this 1st CRADA Amendment Avidea committed to increase its scientific staffing contribution and to provide funding of $22,500 by October 15, 2019 and a further $62,500 by October 15, 2020.
+Added: In October 2020, the CRADA was further amended (“2nd CRADA Amendment”) to defer payment of Avidea’s October 2020 funding contribution of the 1st CRADA Amendment to April 15, 2021.
+Added: In May 2021, the CRADA was further amended (“3rd CRADA Amendment”) to extend the term of the CRADA by 2 additional years and to defer payment of Avidea’s April 2021 funding contribution of the 2nd CRADA Amendment to October 31, 2021.
+Added: In November 2021, the CRADA was further amended (“4th CRADA Amendment”) to expand the scope of the collaborative research to evaluate the therapeutic potential of Avidea’s polymer-based vaccine technology, “Immunotherapeutic Nanoscaffolds” (IMNs), including Star polymers and self-assembling nanoparticles based on amphiphilic polymers (SNAP), in preclinical animal models for cancer, infectious and inflammatory diseases (e.g., induction of suppression and/or tolerance for treating or preventing allergies, autoimmunity, and transplant rejection).
+Added: In October 2022, the CRADA was further amended (“5th CRADA Amendment”) to acknowledge that all of Avidea’s rights, duties and obligations under the CRADA were assumed by Vaccitech North America, Inc.
+Added: (“Vaccitech NA”) following the acquisition of Avidea by Vaccitech plc.
+Added: on December 10, 2021.
+Added: Under the CRADA as amended we own inventions made solely by our staff, and we have an option to enter an exclusive or nonexclusive license to any inventions made solely by NIH staff or made jointly by our staff and NIH under the CRADA.
+Added: NIH retains rights on behalf of the U.S.
+Added: Government in the Licensed Technology as required by statute and NIH policy.
+Added: We have an option to exclusively license any further inventions made under the CRADA.
+Added: Unless earlier terminated, the CRADA will expire on February 23, 2024.
+Added: The parties may terminate the CRADA by mutual consent, or either party may unilaterally terminate the CRADA at any time upon 60 days’ prior written notice.
+Added: 2019 License Agreement with NIH (Vaccitech North America, Inc.)
+Added: In September 2019, Avidea entered into a license agreement with the U.S.
+Added: National Institutes of Health (“NIH”) for the commercial development of products and processes for the prevention and/or treatment of cancer and infectious diseases within the scope of Licensed Patent rights that had been developed under a Cooperative Research and Development Agreement (“CRADA”) entered into by NIH and Avidea in February 2017 and amended in March 2019, December 2020, May 2021, November 2021 and October 2022.
+Added: We are co-owners of all the Licensed Patents under this agreement, and we have an option to exclusively license NIH rights in all inventions made under this CRADA.
+Added: All of Avidea’s rights, duties and obligations under the 2019 License Agreement with NIH were assumed by Vaccitech North America, Inc.
+Added: (“Vaccitech NA”) following the acquisition of Avidea by Vaccitech plc.
+Added: on December 10, 2021.
+Added: The 2019 License Agreement with NIH was amended in September 2022 to note Vaccitech NA’s rights, duties and obligations and also to include newly filed patents developed under the 2017 CRADA as amended.
+Added: Pursuant to the 2019 License Agreement with NIH, NIH granted us a worldwide exclusive license under certain patent rights co-owned by us and NIH related to the use of the SNAPvax and syntholytic technology platforms, among other rights, or the Licensed Technology, to develop, manufacture, use and commercialize licensed products.
+Added: The license to patent rights are exclusive in all fields.
+Added: The Licensed Technology is sublicensable subject to obtaining NIH’s prior written consent (such consent not to be unreasonably withheld) and inclusion of other customary provisions.
+Added: NIH retains rights on behalf of the U.S.
+Added: Government in the Licensed Technology as required by statute and NIH policy.
+Added: Upon execution of the 2019 License Agreement with NIH, we paid NIH a one-time upfront fee of $20,000.
+Added: We are obligated to pay NIH a low single-digit royalty on net sales of any product or process produced by or using the Licensed Technology.
+Added: If we sublicense the Licensed Technology, we will be required to pay NIH a low-single-digit royalty on any non-royalty sublicensing income.
+Added: As of March 23, 2023, NIH has not been paid any royalties under the 2019 License Agreement with NIH.
+Added: In the event that the royalties (excluding the royalty on sublicensing income) owed to NIH do not amount to a specified minimum ranging from the low to mid five figures based on the license year in each year following September 2019, the licensee must also pay NIH the difference between the royalty paid and the applicable minimum royalty payment.
+Added: Within 60 days of execution of the 2019 License Agreement with NIH we paid $5,000 to NIH.
+Added: Within 60 days of January 1, 2020 $5,000 was paid to NIH, being the difference between royalties paid and the minimum sum payable.
+Added: Within 60 days of January 1, 2021 $5,000 was paid to NIH, being the difference between royalties paid and the minimum sum payable.
+Added: Within 60 days of January 1, 2022 $10,000 was paid to NIH, being the difference between royalties paid and the minimum sum payable.
+Added: Within 60 days of January 1, 2023 $10,000 was paid to NIH, being the difference between royalties paid and the minimum sum payable.
+Added: In addition, we are required to pay NIH milestone payments of up to an aggregate of $3.24 million upon the achievement of specified development, regulatory and commercial milestones for each Licensed Product.
+Added: Unless earlier terminated, the 2019 License Agreement with NIH will continue until expiry of the last to expire Licensed Patent.
+Added: 5 patent families licensed under the 2019 License Agreement with NIH that cover the SNAPvax platform, if granted, are expected to expire in April 2038, in May 2039, in October 2039, in February 2042 and in June 2042, without giving effect to any potential patent term extensions or patent term adjustments.
+Added: Two patent families licensed under the 2019 License Agreement with NIH that cover the syntholytic platform, if granted, are expected to expire in April 2040 and in October 2041, without giving effect to any potential patent term extensions or patent term adjustments.
+Added: Either party may terminate for the uncured breach of the other party.
+Added: We may terminate the agreement at any time upon 60 days’ prior written notice.
+Added: NIH may terminate the agreement upon the occurrence of certain events.
+Added: 2017 Research Collaboration Agreement (“RCA”) with Institute of Macromolecular Chemistry, Prague (Vaccitech North America, Inc.)
+Added: In September 2017, Avidea entered into a Research Collaboration Agreement (“RCA”) with the Czech Institute of Macromolecular Chemistry, (“IMC”) to carry out collaborative research for the development of polymer-based immunotherapies for cancer treatment, HIV prevention and recombinant protein delivery.
+Added: Under this RCA Avidea committed to providing bioactive moecules and to developing and deploying animal models for evaluating immunotherapies.
+Added: Under this RCA IMC committed to synthesizing various polymers and bioactive molecules and to linking such polymers and bioactive molecules for use in experiments to characterize their physicochemical properties.
+Added: No funding was exchanged under this RCA.
+Added: All of Avidea’s rights, duties and obligations under the 2017 RCA with IMC were assumed by Vaccitech North America, Inc.
+Added: (“Vaccitech NA”) following the acquisition of Avidea by Vaccitech plc.
+Added: on December 10, 2021.
+Added: Under the RCA we own inventions made solely by our staff, and we have an exclusive option to enter an exclusive or nonexclusive license to any inventions made solely by IMC staff or made jointly by our staff and IMC under the RCA.
+Added: We have secured exclusive
+Added: rights in two patent families that we co-own with IMC under the 2022 License Agreement with IMC as described below.
+Added: We have an exclusive option to exclusively license any further inventions made under the RCA.
+Added: The RCA expired on September 18, 2022.
+Added: Our rights in inventions made under the RCA survive expiry of the RCA.
+Added: 2022 License Agreement with IMC (Vaccitech North America, Inc.)
+Added: In April 2022, we entered into an exclusive license agreement with the Czech Institute of Macromolecular Chemistry, (“IMC”) for the exploitation, development and commercialization of technologies and products within the scope of Licensed Patent rights that had been developed under a Research Collaboration Agreement (“RCA”) entered into by IMC and Avidea in September 2017.
+Added: We are co-owners of all the Licensed Patents under this agreement, and we have an option to exclusively license IMC rights in all inventions made under this RCA.
+Added: Pursuant to the 2022 License Agreement with IMC, IMC granted us a worldwide, exclusive license under certain patent rights co-owned by us and IMC related to the use of polymer-based immunotherapies, among other rights, or the Licensed Technology, to develop, manufacture, use and commercialize licensed products.
+Added: The license to patent rights is exclusive in all fields.
+Added: The Licensed Technology is sublicensable.
+Added: We are obligated to pay IMC a low single-digit royalty on net sales of any product or process produced by or using the Licensed Technology.
+Added: If we sublicense the Licensed Technology, we will be required to pay IMC a low-single-digit royalty on any non-royalty sublicensing income.
+Added: As of March 23, 2023, IMC has not been paid any royalties under the 2022 License Agreement with IMC.
+Added: In addition, we are required to pay IMC milestone payments of up to an aggregate of $820,000 upon the achievement of specified development, regulatory and commercial milestones for each Licensed Product.
+Added: Unless earlier terminated, the 2022 License Agreement with IMC will continue until expiry of the last valid claim of the Licensed Patents.
+Added: One patent family licensed under the 2022 License Agreement with IMC that covers the SNAPvax platform, if granted, is expected to expire in September 2041, without giving effect to any potential patent term extensions or patent term adjustments.
+Added: One patent family licensed under the 2022 License Agreement with IMC that covers the syntholytic platform, if granted, is expected to expire in April 2040, without giving effect to any potential patent term extensions or patent term adjustments.
+Added: Either party may terminate for the uncured breach or insolvency of the other party.
+Added: We may terminate the agreement at any time upon 3 months’ prior written notice.
2019 License Agreement with OUI
In January 2019, we entered into an additional license agreement with OUI, or the 2019 OUI License Agreement.
−Removed: Pursuant to the 2019 OUI License Agreement, OUI granted us a worldwide, license under an additional patent application of OUI related to the rapid
−Removed: production of recombinant adenovirus constructs, to be used as personalized cancer vaccines or emerging pathogen vaccines, and related confidential know-how, or the 2019 Licensed Technology, to develop, manufacture, use and commercialize licensed products.
+Added: Pursuant to the 2019 OUI License Agreement, OUI granted us a worldwide, license under an additional patent application of OUI related to the rapid production of recombinant adenovirus constructs, to be used as personalized cancer vaccines or emerging pathogen vaccines, and related confidential know-how, or the 2019 Licensed Technology, to develop, manufacture, use and commercialize licensed products.
The license is exclusive in the field of personalized cancer vaccines for therapeutic use in humans, non- exclusive in in all other fields and excludes veterinary applications (apart from MERS) and certain other specified indications.
22 unchanged sentences
This license includes the right to generate investigational stockpiles, but excludes any commercial use or sale of Licensed Products and is sublicensable by Oxford solely to its collaborators under the framework agreement entered into on or about the same date as the 2018 License Agreement between Oxford, CEPI and Janssen Vaccines & Prevention B.V.
−Removed: Furthermore, we agreed that the rights retained by
−Removed: OUI under the 2016 OUI License Agreement include the right to allow Oxford to use the MERS Technology to carry out research activities (including in collaboration with other parties) up to and including the performance of Phase 1/2 clinical trials and related activities, and the generation of Licensed Product for research use (but excluding any commercial use or sale of such Licensed Product).
+Added: Furthermore, we agreed that the rights retained by OUI under the 2016 OUI License Agreement include the right to allow Oxford to use the MERS Technology to carry out research activities (including in collaboration with other parties) up to and including the performance of Phase 1/2 clinical trials and related activities, and the generation of Licensed Product for research use (but excluding any commercial use or sale of such Licensed Product).
+Added: We have been informed by Oxford that Janssen Vaccines & Prevention B.V.
+Added: is no longer a party to that framework agreement.
In addition, we agreed to grant to Oxford a fully-paid-up, worldwide, non-exclusive license under the MERS Technology in the Field solely for the purpose of enabling Oxford to grant a sublicense to CEPI in order to address (i) circumstances in which CEPI determines there to be a heightened need for the Licensed Product and that steps should be taken to prepare for such need;
19 unchanged sentences
We are not a party to the AstraZeneca License Agreement and do not have access to a copy of that agreement to verify the accuracy of such extract.
−Removed: In addition, no party to the AstraZeneca License Agreement has confirmed that there are no material terms in that agreement that are not included in the description below that could adversely impact the economic
−Removed: and other terms of the AstraZeneca License Agreement described below.
+Added: In addition, no party to the AstraZeneca License Agreement has confirmed that there are no material terms in that agreement that are not included in the description below that could adversely impact the economic and other terms of the AstraZeneca License Agreement described below.
Moreover, there can be no assurance that the AstraZeneca License Agreement is an enforceable agreement, that the parties thereto will comply with their obligations under that agreement (including any obligations of AstraZeneca to make milestone or royalty payments to OUI), or that the terms of that agreement (including royalty rates and other economic terms) will not be modified by the parties in the future.
1 unchanged sentence
The AstraZeneca License Agreement allows AstraZeneca to pursue, among other things, the commercialization of a vaccine product candidate for the prevention of COVID-19 containing one or more of the ChAdOx1 or ChAdOx2 vectors or their derivatives.
−Removed: AstraZeneca has announced that as of January 13, 2022, the vaccine has been granted a conditional marketing authorisation or emergency use in more than 90 countries.
+Added: AstraZeneca announced that as of January 13, 2022, the vaccine had been granted a conditional marketing authorization or emergency use in more than 90 countries.
It also has Emergency Use Listing from the World Health Organization, which accelerates the pathway to access in up to 144 countries through the COVAX Facility.
Pursuant to the OUI License Agreement Amendment, we received $2.4 million in July 2020 as our share of the upfront fee paid by AstraZeneca.
−Removed: We are also entitled to receive a share of certain regulatory and sales milestones and royalties on net sales of AZD1222, as well as a portion of any sublicensing income payable by AstraZeneca.
−Removed: Our share of the royalties on net sales of AZD1222 is approximately 1.4%.
−Removed: Our understanding is that we will not be entitled to receive any royalties or payments from sub-licensees from the commercialization of AZD1222 until after the pandemic period, which was defined as a period that would end on July 1, 2021 (or such later date when AstraZeneca, in good faith, determines that the COVID-19 pandemic is over).
−Removed: However, our understanding is that we will be entitled to receive our share of any regulatory milestone payments during the pandemic period.
−Removed: The royalty term for net sales of AZD1222 shall commence once the pandemic period has ended and continue, on a country-by-country basis, until the later of (i) the date upon which the vaccine is no longer subject to patent protection in such country, (ii) expiration of regulatory exclusivity for the vaccine in such country or (iii) ten years from the first commercial sale of the vaccine in such country.
+Added: We are also entitled to receive a share of certain regulatory and sales milestones and royalties on net sales of Vaxzevria, as well as a portion of any sublicensing income payable by AstraZeneca.
+Added: Our share of the royalties on net sales of Vaxzevria is approximately 1.4%.
+Added: Our understanding is that we were not entitled to receive any royalties or payments from sub-licensees from the commercialization of Vaxzevria until after the pandemic period, which was defined as a period that would end on July 1, 2021 (or such later date when AstraZeneca, in good faith, determines that the COVID-19 pandemic is over).
+Added: However, our understanding is that we would be entitled to receive our share of any regulatory milestone payments during the pandemic period.
+Added: The royalty term for net sales of Vaxzevria commenced in 2022 and will continue, on a country-by-country basis, until the later of (i) the date upon which the vaccine is no longer subject to patent protection in such country, (ii) expiration of regulatory exclusivity for the vaccine in such country or (iii) ten years from the first commercial sale of the vaccine in such country.
Master Collaboration Agreement with CanSino Biologics Inc.
10 unchanged sentences
Furthermore, unless agreed otherwise in a project agreement, for any product which we collaboratively develop, CanSino has the exclusive and sub-licensable right to manufacture and supply all master virus seed and clinical adenoviral material necessary for the development and sale of any products by either party in their respective territories.
−Removed: CanSino will supply any
−Removed: such material to be used by us for the manufacture of products to be sold by us (or our sub-licensees) at the price of 15% to 30% over cost of goods sold, or COGS.
+Added: CanSino will supply any such material to be used by us for the manufacture of products to be sold by us (or our sub-licensees) at the price of 15% to 30% over cost of goods sold, or COGS.
COGS is equal to the reasonable COGS for equivalent material manufactured by CanSino or its subcontractors for sale by CanSino or its sub-licensees.
29 unchanged sentences
Upon the expiration of the term, we agreed to grant CanSino a royalty-free, perpetual, sub-licensable, non-exclusive license to use our Background IPR and our New IPR used to develop, incorporated in, or referenced in any products that are the subject of the project agreement to the extent necessary for CanSino to undertake research, develop, manufacture and commercialize such products in the CanSino Territory.
−Removed: Pursuant to the CanSino Agreement, upon the expiration or earlier termination of the project agreement, except for termination by CanSino for our breach, CanSino agreed to grant us a royalty-free, perpetual, sub-licensable, non-exclusive license to use their Background IPR and New IPR used to develop, incorporated
−Removed: in, or referenced in any products that are the subject of the project agreement to the extent necessary for us to undertake research, develop, manufacture and commercialize such products in the Vaccitech Territory.
+Added: Pursuant to the CanSino Agreement, upon the expiration or earlier termination of the project agreement, except for termination by CanSino for our breach, CanSino agreed to grant us a royalty-free, perpetual, sub-licensable, non-exclusive license to use their Background IPR and New IPR used to develop, incorporated in, or referenced in any products that are the subject of the project agreement to the extent necessary for us to undertake research, develop, manufacture and commercialize such products in the Vaccitech Territory.
Unless we terminate the project agreement early for CanSino’s breach, upon early termination after completion of a Phase 1 trial, we will continue to pay CanSino a low single-digit royalty on net sales of the product by us or our sub-licensees in the Vaccitech Territory, for the remainder of the Term.
41 unchanged sentences
In the event of termination of the 2016 OUI License Agreement, we may terminate the VOLT License Agreement in respect of any of the VOLT Licensed Technology that is licensed to us by OUI, and VOLT and OUI shall enter into a direct license containing the same obligations and liabilities as set forth in the VOLT License Agreement.
−Removed: The VOLT License Agreement was subsequently amended in July 2019 by two separate agreements for the research, development, and commercialization of cancer vaccines targeting MAGE-A3 and NY-ESO-1 for the treatment of various forms of cancer under the VOLT Licensed Technology.
+Added: The VOLT License Agreement was subsequently amended in July 2019 by two separate agreements for the research, development, and commercialization of cancer immunotherapy targeting MAGE-A3 and NY-ESO-1 for the treatment of various forms of cancer under the VOLT Licensed Technology.
Such amendments further elaborated on the parties’ respective rights and obligations, including with respect to VOLT’s payment obligations to us.
5 unchanged sentences
We, or our collaborators and licensors, file patent applications directed to our key product candidates in an effort to establish intellectual property positions to protect our product candidates as well as uses of our product candidates for the prevention and/or treatment of diseases.
−Removed: As of March 25, 2022, we own a pending patent application filed in the United Kingdom relating to our novel regimens.
−Removed: In addition, we have in-licensed certain patent families relating to our key technology platforms and product candidates, including seven issued U.S.
−Removed: patents, seven pending U.S.
−Removed: patent applications, ten issued foreign patents and 77 pending foreign patent applications.
−Removed: Following the acquisition of Avidea in December 2021 we control a further patent portfolio comprising in-licensed and co-owned patent families,
−Removed: including five pending U.S.
−Removed: patent applications, four issued foreign patents, 27 pending foreign patent applications and three pending Patent Cooperation Treaty, or PCT, patent applications.
+Added: As of March 23, 2023, we own a patent family relating to our novel regimens that includes two pending U.S.
+Added: patent applications, two pending foreign patent applications and one pending Patent Cooperation Treaty, or PCT, patent application.
+Added: In addition, we have in-licensed certain patent families relating to our key technology platforms and product candidates, including eight issued U.S.
+Added: patents, eight pending U.S.
+Added: patent applications, 16 issued foreign patents and 80 pending foreign patent applications.
+Added: Following the acquisition of Avidea in December 2021 we control a further patent portfolio comprising in-licensed and co-owned patent families, including eight pending U.S.
+Added: patent applications, (including two pending U.S.
+Added: provisional patent applications), four issued foreign patents, 30 pending foreign patent applications and four pending PCT patent applications.
Universal Vector Technology Platforms
1 unchanged sentence
As of March 23, 2023, with regard to our ChAdOx1 expression vector, we in-license from OUI a patent family that includes two issued U.S.
−Removed: patents with claims directed to the composition of matter of the ChAdOx-1 adenovirus vector and methods of using such a vector, and 6 foreign patents granted in such jurisdictions as Australia, China, Europe (validated in 12 countries including Denmark, France, Germany, Italy, Spain, and Great Britain), India and Japan.
+Added: patents with claims directed to the composition of matter of the ChAdOx1 adenovirus vector and methods of using such a vector, and 9 issued foreign patents granted in such jurisdictions as Australia, Canada, China, Europe (validated in 12 countries including Denmark, France, Germany, Italy, Spain, and Great Britain), India, Japan, Singapore and South Africa.
+Added: A second granted European patent with further claims directed to the composition of matter of ChAdOx adenovirus vector is validated in France, Germany and Great Britain.
This patent family also includes a pending U.S.
−Removed: patent application and 4 pending foreign patent applications.
+Added: patent application.
The granted patents and pending applications, if issued, are expected to expire in 2032, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
−Removed: Novel Simian Expression Vector
−Removed: As of March 25, 2022, with regard to our novel simian expression vector technology, we own a pending patent application filed in the United Kingdom with claims directed to our novel simian expression vector.
−Removed: If a patent were to issue from a patent application claiming the benefit of this United Kingdom patent application, such a patent would be expected to expire in 2041 without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: Patent term extension applications are pending in Japan and 11 European Patent Convention countries including the United Kingdom, France, Germany, Italy and Spain, based on marketing authorisations received by AstraZeneca for Vaxzevria, and patent term extension has been granted in Australia.
Adenoviral Promoter
7 unchanged sentences
patents and one granted European patent (validated in 9 countries including Denmark, France, Germany, Italy, Spain, and Great Britain) that are expected to expire in 2031, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: Our proprietary SNAPvax technology is covered by a patent portfolio that includes one patent family we own, 6 patent families that we co-own and one patent family that we in-license from OUI.
+Added: As of March 23, 2023, we in-license a patent family from OUI that includes one pending U.S.
+Added: patent application and one pending European patent application that are expected to expire in 2035, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: As of March 23, 2023, we own a patent family that includes four issued foreign patents that are expected to expire in 2030, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: As of March 23, 2023, we co-own a patent family that includes one pending U.S.
+Added: patent application, one pending European patent application and a further 10 pending foreign patent applications that are expected to expire in 2038, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: We have exclusively licensed rights in this patent family, which resulted from work carried out under a Collaborative research and Development Agreement, or CRADA, between Avidea and the U.S.
+Added: National Institutes of Health (“NIH”).
+Added: As of March 23, 2023, we co-own a patent family that includes one pending U.S.
+Added: patent application, one pending European patent application and a further 5 pending foreign patent applications that are expected to expire in 2039, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: We have exclusively licensed rights in this patent family, which resulted from work carried out under a CRADA between Avidea and the NIH.
+Added: As of March 23, 2023, we co-own a patent family that includes one pending U.S.
+Added: patent application, one pending European patent application and a further 2 pending foreign patent applications that are expected to expire in 2039, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: We have exclusive rights in this patent family, which resulted from work carried out under a CRADA between Avidea and the NIH.
+Added: As of March 23, 2023, we co-own a patent family that includes one pending international PCT patent application that is expected to expire in 2042, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: We have exclusive rights in this patent family, which resulted from work
+Added: carried out under a CRADA between Avidea and the NIH.
+Added: As of March 23, 2023, we co-own a patent family that includes one pending international PCT patent application and one further pending foreign patent applications that are expected to expire in 2042, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: We have exclusive rights in this patent family, which resulted from work carried out under a CRADA between Avidea and the NIH.
+Added: As of March 23, 2023, we co-own a patent family that includes one pending U.S.
+Added: patent application, one pending foreign patent application and one pending international PCT patent application that are expected to expire in 2041, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: We have licensed exclusive rights in this patent family, which resulted from work carried out under a Research Collaboration Agreement, or RCA, between Avidea and the Institute of Macromolecular Chemistry, Prague (“IMC”).
+Added: Our proprietary Syntholytic technology is covered by a patent portfolio that includes one patent family we own, 2 patent families that we co-own and one patent family that we in-license from OUI.
+Added: As of March 23, 2023, we in-license a patent family from OUI that includes one pending U.S.
+Added: patent application and one pending European patent application that are expected to expire in 2035, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: As of March 23, 2023, we own a patent family that includes four issued foreign patents that are expected to expire in 2030, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: As of March 23, 2023, we co-own a patent family that includes one pending U.S.
+Added: patent application, one pending European patent application and a further 6 pending foreign patent applications that are expected to expire in 2040, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: We have exclusively rights in this patent family, which resulted from work carried out under a CRADA between Avidea and the NIH, and we have licensed exclusive rights in this patent family, which resulted from work carried out under a RCA between Avidea and the IMC.
+Added: As of March 23, 2023, we co-own a patent family that includes one pending international PCT patent application that is expected to expire in 2041, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: We have exclusively rights in this patent family, which resulted from work carried out under a CRADA between Avidea and the NIH.
Product Candidates
2 unchanged sentences
As of March 23, 2023, the patent family includes one issued U.S.
−Removed: patent and nine foreign patent applications pending in jurisdictions including Europe, Australia, Canada, China, and Japan.
+Added: patent, one pending U.S.
+Added: patent application and ten foreign patent applications pending in jurisdictions including Europe, Australia, Canada, China, and Japan.
If patents were to issue from such patent applications, they would be expected to expire in 2038, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
1 unchanged sentence
Our VTP-300 product candidate comprises a ChAdOx1HBV vector and a MVA-HBV vector, where each vector incorporates an engineered HBV antigen.
−Removed: As of March 25, 2022, we in-license from OUI a patent family with claims directed to a multi-HBV immunogen viral vector vaccine that includes a pending U.S.
+Added: As of March 23, 2023, we in-license from OUI a patent family with claims directed to a multi-HBV immunogen viral vector vaccine that includes one pending U.S.
patent application and 17 foreign patent applications pending in jurisdictions including Europe, Australia, Canada, China, and Japan.
−Removed: If patents were to issue from such patent applications, they would be expected to expire in 2038, without giving effect to any potential patent term extensions or patent term adjustments and assuming
−Removed: payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: If patents were to issue from such patent applications, they would be expected to expire in 2038, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
In addition, we also rely on patent protection afforded by the patent family directed to the ChAdOx1 expression vector, which is expected to expire in 2032, and the patent family directed to our MVA-poxvirus promoter, which is expected to expire in 2031, as discussed above.
Our VTP-600 product candidate comprises a ChAdOx1MAGE-NYESO vector, a MVA-MAGE vector, and a MVA-NYESO vector.
−Removed: We in-license from Ludwig Institute a patent family with claims directed to a chimpanzee adenovirus vector encapsidating a nucleic acid molecule encoding a MAGE antigen, a NY- ESO-1 antigen or both a MAGE antigen and a NY-ESO-1 antigen.
+Added: We in-license from Ludwig Institute a patent family with claims directed to a chimpanzee adenovirus vector encapsulating a nucleic acid molecule encoding a MAGE antigen, a NY- ESO1 antigen or both a MAGE antigen and a NY-ESO1 antigen.
As of March 23, 2023, the patent family includes one pending U.S.
patent application and 8 foreign patent applications pending in jurisdictions including Europe, Australia, Canada, China, and Japan.
−Removed: If a patent were to issue from a patent application claiming the benefit of this PCT application, such a patent would be expected to expire in 2039, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: If a patent were to issue from a patent application claiming the benefit of this PCT
+Added: application, such a patent would be expected to expire in 2039, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
In addition, we also rely on patent protection afforded by the patent family directed to the ChAdOx1 expression vector, which is expected to expire in 2032, the patent family directed to our adenoviral promotor, which is expected to expire in 2028, and the patent family directed to our MVA-poxvirus promoter, which is expected to expire in 2031, as discussed above.
−Removed: Our VTP-800 product candidate comprises a ChAdOx1-5T4 vector and a MVA-5T4 vector, where each vector incorporates an engineered 5T4 antigen.
+Added: Our VTP-800 and VTP-850 product candidate comprises a ChAdOx15T4 vector and a MVA5T4 vector, where each vector incorporates an engineered 5T4 antigen in combination with additional antigens.
We in-license from OUI a patent family with claims directed to a composition for inducing a T Cell response comprising a MVA vector expressing the 5T4 antigen polypeptide.
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As of March 23, 2023, the patent family includes one pending U.S.
−Removed: patent application and nine foreign patent applications pending in jurisdictions including Europe, Australia, Canada, China, and Japan.
+Added: patent application and 13 foreign patent applications pending in jurisdictions including Europe, Australia, Canada, China, and Japan.
If a patent were to issue from a patent application claiming the benefit of this PCT application, such a patent would be expected to expire in 2039, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
We also rely on patent protection afforded by the patent family directed to the ChAdOx1 expression vector, which is expected to expire in 2032 and the patent family directed to our adenoviral promotor, which is expected to expire in 2028, as discussed above.
+Added: Our VTP-1100 product candidate includes SNAPvax technology to target HPV16+ cancers.
+Added: We co-own a patent family with claims directed to methods of treating cancers using SNAPvax compositions.
+Added: As of March 23, 2023, the patent family includes one pending U.S.
+Added: provisional patent application.
+Added: If a patent were to issue from a patent application claiming the benefit of this U.S.
+Added: provisional application, such a patent would be expected to expire in 2043, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: We have exclusive rights in this patent family, which resulted from work carried out under a CRADA between Vaccitech and the NIH.
+Added: In addition, we rely on patent protection afforded by the patent families directed to the SNAPvax platform technology, which are expected to expire between 2030 and 2042, as discussed above.
+Added: Our VTP-1000 product candidate includes SNAPvax technology to provide tolerizing immunotherapy for celiac disease.
+Added: We co-own a patent family with claims directed to compositions and methods for treating celiac disease.
+Added: As of March 23, 2023, the patent family includes one pending U.S.
+Added: provisional patent application.
+Added: If a patent were to issue from a patent application claiming the benefit of this U.S.
+Added: provisional application, such a patent would be expected to expire in 2043, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
+Added: In addition, we rely on patent protection afforded by the patent families directed to the SNAPvax platform technology, which are expected to expire between 2030 and 2042, as discussed above.
Individual patents have terms for varying periods depending on the date of filing of the patent application or the date of patent issuance and the legal term of patents in the countries in which they are obtained.
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We may be unable to obtain, maintain and protect the intellectual property rights necessary to conduct our business, and we may be subject to claims that we infringe or otherwise violate the intellectual property rights of others, which could materially harm our business.
−Removed: For more information about the risks associated with our efforts to obtain adequate intellectual property protection for our product candidates, and the enforcement of such intellectual property rights, as well as the risks associated with third party intellectual property rights, see the section titled “Risk Factors — Risks Related to Our Intellectual Property.” With regard to our VTP-300 product candidate, we are aware of third- party patents in the United States with claims which may be relevant
−Removed: to this product candidate.
+Added: For more information about the risks associated with our efforts to obtain adequate intellectual property protection for our product candidates, and the enforcement of such intellectual property rights, as well as the risks associated with third party intellectual property rights, see the section titled “Risk Factors — Risks Related to Our Intellectual Property.” With regard to our VTP-300 product candidate, we are aware of third- party patents in the United States with claims which may be relevant to this product candidate.
See “Risk Factors — Risks Related to Intellectual Property — The intellectual property landscape around immunotherapeutics and viral-vector based vaccines is crowded and dynamic, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights and such claims may be costly and time-consuming and may prevent or delay our product discovery and development efforts.”
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As a condition of approval, the FDA generally requires that a sponsor of a drug or biological product receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials to verify the clinical benefit in relationship to the surrogate endpoint or ultimate outcome in relationship to the clinical benefit.
+Added: Under the Food and Drug Omnibus Reform Act of 2022, or FDORA, the FDA is now permitted to require, as appropriate, that such trials be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval.
+Added: Sponsors are also required to send updates to the FDA every 180 days on the status of such studies, including progress toward enrollment targets, and the FDA must promptly post this information publicly.
+Added: Under FDORA, the FDA has increased authority for expedited procedures to withdraw approval of a drug or indication approved under accelerated approval if, for example, the sponsor fails to conduct such studies in a timely manner and send the necessary updates to the FDA, or if a confirmatory trial fails to verify the predicted clinical benefit of the product.
In addition, the FDA currently requires, unless otherwise informed by the agency, pre-approval of promotional materials for products receiving accelerated approval, which could adversely impact the timing of the commercial launch of the product.
3 unchanged sentences
We currently rely, and may continue to rely, on third parties for the production of clinical and commercial quantities of any products that we may commercialize.
−Removed: Manufacturers of our products are required to comply
−Removed: with applicable requirements in the cGMP regulations, including quality control and quality assurance and maintenance of records and documentation.
+Added: Manufacturers of our products are required to comply with applicable requirements in the cGMP regulations, including quality control and quality assurance and maintenance of records and documentation.
Other post-approval requirements applicable to biological products include reporting of cGMP deviations that may affect the identity, potency, purity and overall safety of a distributed product, record-keeping requirements, reporting of adverse effects, reporting updated safety and efficacy information, and complying with electronic record and signature requirements.
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Biological product manufacturers and other entities involved in the manufacture and distribution of approved biological products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws, including applicable tracking and tracing requirements.
−Removed: Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance.
+Added: Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain
+Added: cGMP compliance.
Discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including withdrawal of the product from the market.
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Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical trial or trials.
−Removed: Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product and, for
−Removed: products administered multiple times, the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
+Added: Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
FDA will not accept an application for a biosimilar or interchangeable product based on the reference biological product until four years after the date of first licensure of the reference product, and FDA will not approve an application for a biosimilar or interchangeable product based on the reference biological product until twelve years after the date of first licensure of the reference product.
12 unchanged sentences
If our operations result in contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and governmental fines.
−Removed: We believe that we are in material compliance with applicable environmental laws and that continued compliance therewith will not have a material adverse effect on our business.
+Added: We believe that we are in material compliance with
+Added: applicable environmental laws and that continued compliance therewith will not have a material adverse effect on our business.
We cannot predict, however, how changes in these laws may affect our future operations.
11 unchanged sentences
a streamlined application procedure via a single-entry point through the Clinical Trials Information System, or CTIS;
−Removed: a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical
−Removed: trial sponsors;
+Added: a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors;
and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts (Part I contains scientific and medicinal product documentation and Part II contains the national and patient-level documentation).
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If the product has not received a national marketing authorization in any Member State at the time of application, it can be approved simultaneously in various European Union Member States through the decentralized procedure.
−Removed: As with the centralized procedure, the competent authorities of the European Union
−Removed: Member States assess the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy before granting the marketing authorization.
+Added: As with the centralized procedure, the competent authorities of the European Union Member States assess the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy before granting the marketing authorization.
The application used to submit the BLA in the United States is similar to that required in the European Union, with certain exceptions.
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Sales of any product, if approved, depend, in part, on the extent to which such product will be covered by third-party payors, such as federal, state, and foreign government healthcare programs, commercial insurers, and managed healthcare organizations.
−Removed: Decisions regarding whether to cover any of our product candidates, if approved, the extent of coverage, and amount of
−Removed: reimbursement to be provided are made on a plan-by-plan basis.
+Added: Decisions regarding whether to cover any of our product candidates, if approved, the extent of coverage, and amount of reimbursement to be provided are made on a plan-by-plan basis.
Further, no uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor to payor.
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HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing civil actions.
−Removed: federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to annually report to the Centers for Medicare and Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians (currently defined to include doctors of medicine or osteopathy, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
−Removed: Effective January 1, 2022, these reporting obligations extend to include transfers of value made to certain non-physician practitioners, such as physician assistants and nurse practitioners.
+Added: federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to annually report to the Centers for Medicare and Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians (currently defined to include doctors of medicine or osteopathy, dentists, optometrists, podiatrists, and chiropractors), other licensed non-physician health care practitioners, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
Additionally, we may be subject to federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs and federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.
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and state and foreign laws governing the privacy and security of health information which, in some cases, differ from each other in significant ways, and may not have the same effect, thus complicating compliance efforts.
−Removed: If our operations are found to
−Removed: be in violation of any of such laws or any other governmental regulations that apply, we or our officers, directors, employees, contractors, or agents may be subject to penalties, including, without limitation, significant civil, criminal, and administrative penalties;
+Added: If our operations are found to be in violation of any of such laws or any other governmental regulations that apply, we or our officers, directors, employees, contractors, or agents may be subject to penalties, including, without limitation, significant civil, criminal, and administrative penalties;
exclusion from government-funded healthcare programs, such as Medicare and Medicaid or similar programs in other countries or jurisdictions;
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Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation as well as reputational harm.
−Removed: For example, California recently enacted the California Consumer Privacy Act, or the CCPA, and the California Privacy Rights Act, or the CPRA.
−Removed: Also, on March 2, 2021, Virginia enacted the Consumer Data Protection Act, or the CDPA, and, on July 8, 2021, Colorado’s governor signed the Colorado Privacy Act, the CPA, into law.
−Removed: The CDPA and the CPA will both become effective January 1, 2023.
+Added: For example, the California Consumer Privacy Act, or the CCPA, as amended by the California Privacy Rights Act, or the CPRA, went into effect on January 1, 2023.
+Added: Also, on January 1, 2023, the Virginia Consumer Data Protection Act, or the CDPA, became effective.
+Added: Further, many additional United States state privacy laws will go into effect throughout 2023:
+Added: the Colorado Privacy Act, or the CPA (July 1, 2023);
+Added: the Connecticut Data Privacy Act, or the CTDPA (July 1, 2023);
+Added: and the Utah Consumer Privacy Act, or the UCPA (December 31, 2023).
+Added: The CDPA, CPA, CTDPA, and UCPA are substantially similar in scope and contain many of the same requirements and exceptions as the CCPA, including a general exemption for clinical trial data and information governed by HIPAA.
+Added: Any of these laws may broaden their scope in the future, and similar laws have been proposed on both a federal level and in more than half of the states in the United States.
In addition, a number of other states have proposed new privacy laws, some of which are similar to the above discussed recently passed laws.
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While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA such as removing penalties, which started on January 1, 2019, for not complying with the ACA’s individual mandate to carry health insurance, delaying the implementation of certain ACA-mandated fees, and increasing the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D.
−Removed: Since its enactment, there have been judicial, Congressional and executive challenges to certain aspects of the ACA.
On June 17, 2021, the U.S.
Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.
−Removed: Prior to the Supreme Court’s decision, President Biden issued an executive order to initiate a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace.
−Removed: The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.
+Added: Prior to the Supreme Court’s decision, President Biden issued an executive order that, in part, instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.
It is unclear how other healthcare reform measures of the Biden administration or other efforts, if any, to challenge, repeal or replace the ACA will impact our business.
In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted.
−Removed: ● On August 2, 2011, the U.S.
Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year.
−Removed: These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022 due to the ongoing COVID-19 pandemic.
−Removed: Following the temporary suspension, a 1% payment reduction will occur beginning April 1, 2022 through June 30, 2022, and the 2% payment reduction will resume on July 1, 2022.
−Removed: ● On January 2, 2013, the U.S.
−Removed: American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers.
−Removed: ● On April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces.
−Removed: ● On May 30, 2018, the Right to Try Act, was signed into law.
−Removed: The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval.
+Added: These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2031, absent further legislative action.
+Added: American Taxpayer Relief Act of 2012 further reduced Medicare payments to several types of providers.
+Added: ● The Right to Try Act (2018), among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval.
Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program.
There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.
−Removed: ● On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020.
−Removed: ● On December 20, 2019, former President Trump signed into law the Further Consolidated Appropriations Act (H.R.
−Removed: 1865), which repealed the Cadillac tax, the health insurance provider tax, and the medical device excise tax.
−Removed: It is impossible to determine whether similar taxes could be instated in the future.
−Removed: Prior to the Biden administration, on October 13, 2017, former President Trump signed an Executive Order terminating the cost-sharing subsidies that reimburse insurers under the ACA.
−Removed: The former Trump administration concluded that cost-sharing reduction, or CSR, payments to insurance companies required under the ACA have not received necessary appropriations from Congress and announced that it will discontinue these payments immediately until those appropriations are made.
−Removed: Several state Attorneys General filed suit to stop the administration from terminating the subsidies, but their request for a restraining order was denied by a federal judge in California on October 25, 2017.
−Removed: On August 14, 2020, the U.S.
−Removed: Court of Appeals for the Federal Circuit ruled in two separate cases that the federal government is liable for the full amount of unpaid CSRs for the years preceding and including 2017.
−Removed: For CSR claims made by health insurance companies for years 2018 and later, further litigation will be required to determine the amounts due, if any.
−Removed: Further, on June 14, 2018, the U.S.
−Removed: Court of Appeals for the Federal Circuit ruled that the federal government was not required to pay more than $12 billion in ACA risk corridor payments to third-party payors who argued the payments were owed to them.
−Removed: On April 27, 2020, the United States Supreme Court reversed the U.S.
−Removed: Court of Appeals for the Federal Circuit’s decision and remanded the case to the U.S.
−Removed: Court of Federal Claims, concluding the government has an obligation to pay these risk corridor payments under the relevant formula.
−Removed: It is unclear what impact these rulings will have on our business.
−Removed: In addition, there have been several changes to the 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for medications sold to certain health care facilities.
−Removed: On December 27, 2018, the District Court for the District of Columbia invalidated a reimbursement formula change under the 340B drug pricing program, and CMS subsequently altered the FYs 2019 and 2018 reimbursement formula on specified covered outpatient drugs, or SCODs.
−Removed: The court ruled this change was not an “adjustment” which was within the Secretary’s discretion to make but was instead a fundamental change in the reimbursement calculation.
−Removed: However, most recently, on July 31, 2020, the U.S.
−Removed: Court of Appeals for the District of Columbia Circuit overturned the district court’s decision and found that the changes were within the Secretary’s authority.
−Removed: On September 14, 2020, the plaintiffs-appellees filed a Petition for Rehearing En Banc ( i.e.
−Removed: , before the full court), but was denied on October 16, 2020.
−Removed: Plaintiffs-appellees filed a petition for a writ of certiorari at the Supreme Court on February 10, 2021.
−Removed: On Friday July 2, 2021, the Supreme Court granted the petition.
−Removed: It is unclear how these developments could affect covered hospitals who might purchase our future products and affect the rates we may charge such facilities for our approved products in the future, if any.
+Added: ● The Inflation Reduction Act of 2022, or IRA, includes several provisions that will impact our business to varying degrees, including provisions that reduce the out-of-pocket cap for Medicare Part D beneficiaries to $2,000 starting in 2025;
+Added: impose new manufacturer financial liability on certain drugs in Medicare Part D, allow the U.S.
+Added: government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition, require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation, and delay the rebate rule that would limit the fees that pharmacy benefit managers can charge.
+Added: Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one rare disease designation and for which the only approved indication is for that disease or condition.
+Added: If a product receives multiple rare disease designations or has multiple approved indications, it will not qualify for the orphan drug exemption.
+Added: The effects of the IRA on our business and the healthcare industry in general are not yet known.
+Added: In addition, there have been several judicial challenges to the 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for medications sold to certain health care facilities.
+Added: These include challenges to the government’s reimbursement formula on specified covered outpatient drugs and disputes over potential product diversion through the use of “contract pharmacies,” among other issues.
+Added: It is unclear how these challenges could affect covered hospitals who might purchase our future products and affect the rates we may charge such facilities for our approved products in the future, if any.
Additionally, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices.
11 unchanged sentences
However, on December 29, 2021 CMS rescinded the Most Favored Nations rule.
−Removed: Additionally, on November 30, 2020, HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under
−Removed: Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.
+Added: On November 30, 2020, HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.
The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers.
−Removed: Pursuant to court order, the removal and addition of the aforementioned safe harbors were delayed and recent legislation imposed a moratorium on implementation of the rule until January 1, 2026.
+Added: Pursuant to court order, the removal and addition of the aforementioned safe harbors were delayed, and the IRA extended the moratorium on implementation until January 1, 2032.
Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, both the Biden administration and Congress have indicated that they will continue to seek new legislative measures to control drug costs.
−Removed: Although a number of these and other proposed measures may require additional authorization to become effective, Congress and President Joseph Biden have each indicated that they will continue to seek new legislative and/or administrative measures to control drug costs.
+Added: Although a number of these and other proposed measures may require additional authorization to become effective, Congress and President Biden have each indicated that they will continue to seek new legislative and/or administrative measures to control drug costs.
Additional state and federal healthcare reform measures may be adopted in the future.
−Removed: Further, it is possible that additional governmental action is taken in response to the COVID-19 pandemic.
+Added: Further, it is possible that additional governmental action is taken in response to COVID-19.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Employees and Human Capital Resources
−Removed: As of December 31, 2021, we had 72 full-time and part-time employees, including 14 from the acquisition of Avidea in December 2021.
+Added: As of December 31, 2022, we had 107 full-time and part-time employees, of which 74 were located in the United Kingdom, and 33 located in the United States.
As of December 31, 2022, 57% of our workforce and 61% of our leadership (at Director level and above) were female.
1 unchanged sentence
Of our full and part-time employees, 37 have Ph.D.
−Removed: degrees and are engaged in research and development activities.
+Added: degrees, and 75 are engaged in research and clinical development activities.
+Added: A breakdown of the employment statistics as of December 31, 2022 is as follows:
+Added: Director/Vice President
+Added: Scientists & Support Functions
+Added: Black, Caribbean, or African
+Added: Mixed, other or multiple ethnic groups
+Added: Not disclosed
Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
2 unchanged sentences
The principal purposes of our equity incentive plans are to attract, retain and reward personnel through the grant of equity-based compensation awards.
−Removed: We believe that attracting and retaining talent increases shareholder value and the furthers the success of our company by motivating our employees to perform to the best of their abilities and achieve our objectives.
+Added: We believe that attracting and retaining talent increases shareholder value and furthers the success of our company by motivating our employees to perform to the best of their abilities and achieve our objectives.
We employ individuals based on their experience and ability, and we are committed to promoting diversity and inclusion in our work environment.
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During the COVID-19 pandemic, our continuing focus on safe working practices enabled us to preserve business continuity without sacrificing our commitment to keeping our colleagues and workplace visitors safe.
−Removed: As we continue to grow, we also intend to improve our overall environmental, social, and governance, or ESG, efforts.
−Removed: In 2022, we plan to perform an assessment of our ESG impacts and initiatives.
−Removed: Following this assessment, we intend to create specific goals and objectives to ensure we are addressing any deficiencies or gaps identified in the assessment.
+Added: As we continue to grow, we also intend to expand our overall environmental, social, and governance, or ESG, efforts.
+Added: In 2022, we assigned oversight for ESG to the Nominating and Governance Committee who were tasked with performing an assessment of our ESG impacts and establishing initiatives.
+Added: Following this assessment, we have created specific goals and objectives to monitor and improve specific metrics.
+Added: These include:
+Added: Environmental – the impact Vaccitech has on the environment, including its assessment of carbon footprint and the reporting thereof for new facilities.
+Added: Social – the impact Vaccitech has on society, including the impact on external groups through the development of life-saving products, the impact in low- and middle-income countries and clinical trial diversity.
+Added: For internal groups the focus is on employees and how Vaccitech monitors and maintains gender pay parity, expands employee diversity, enhances engagement and morale, and minimizes staff turnover.
+Added: Corporate Governance – how is the company run, to include diversity and inclusion within the company and the board of directors, board independence and the ratio of executive compensation to employee compensation.
+Added: Carbon emissions
+Added: The group has calculated the emissions for the year ended December 31, 2022 and 2021 in tons of carbon dioxide equivalent (“tCO2e”).
+Added: The carbon footprint for the group for the years ended December 31, 2022 and 2021 are as follows:
+Added: December 31, 2022
+Added: December 31, 2021
+Added: % Total emissions
+Added: % Total emissions
+Added: For clarity, scope 1 emissions are direct emissions produced from activities owned or controlled by the Company.
+Added: Scope 2 emissions are indirect emissions related to the generation of the electricity consumed and purchased by Vaccitech.
+Added: We have used the most recent evidence or estimates provided by our energy supply partners to generate our disclosure of emissions for the period.
+Added: Standard emissions factors from the “UK Government GHG Conversion Factors for Company Reporting (2022)” guidance were applied to estimate emissions.
+Added: Electricity usage at our leased facilities in the United Kingdom and United States are responsible for the majority of our greenhouse gas emissions, with the remainder due to operations conducted within our laboratory.
+Added: The increase in emissions is attributable to incurring 12 months of emissions from the acquisition of Avidea in December 2021, which reported negligible emissions in 2021, and the overlap of leased facilities in the U.K.
+Added: in 2022, notably the fitout and relocation of our corporate headquarters in July 2022, incurring 7 months of emissions across 2 sites in the U.K.
+Added: Our corporate headquarters moved from a 5,059 square foot facility on the Oxford Science Park to an approximate 31,000 square foot facility on the Harwell Science and Innovation Campus.
+Added: Electricity, heating and cooling usage are the majority of our greenhouse gas emissions in these locations.
+Added: The group has elected not to include the voluntary disclosure for Scope 3 emissions.
+Added: For the year ended December 31, 2022, the split of emissions by geography is as follows:
+Added: % Total emissions
+Added: The group considers that the intensity ratio of tons of carbon dioxide per full-time employee, as a suitable metric for its operations for the years ended December 31, 2022, and 2021 are as follows:
+Added: December 31, 2022
+Added: December 31, 2021
+Added: tCO2e /employee
+Added: Average employees
+Added: tCO2e /employee
+Added: Average employees
+Added: Intensity ratio
+Added: The tons of carbon dioxide per employee has increased year on year, primarily as a result of an increase in the size of our leased facilities in both the UK and the US, and an increase in our average headcount of 70%.
+Added: Additionally, as we have expanded our facilities, more employees have been able to work from the office and therefore consumed more greenhouse gas emissions than in 2021, when many non-laboratory based employees were still working from home due to space limitations at the prior facilities and the COVID-19 pandemic.
+Added: The directors have established that the Nominations and Corporate Governance Committee are to have oversight of the assessment and strategy on how to reduce our energy consumption and thereby reducing our carbon footprint.
Available Information
We maintain an internet website at https://www.vaccitech.co.uk/ and make available free of charge through our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, including exhibits and amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act of 1934, or the Exchange Act.
−Removed: We make these reports available through our website as soon as reasonably practicable after we electronically file such reports with, or furnish such reports to,
+Added: We make these reports available through our website as soon as reasonably practicable after we electronically file such reports with, or furnish such reports to, the SEC.
You can review our electronically filed reports and other information that we file with the SEC on the SEC’s web site at http://www.sec.gov.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.