ChAdOx1 MVA 5T4 vaccine (Vaccitech)

OXFORD, United Kingdom, June 12, 2023 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC) (the Company, we or us), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics for the treatment of autoimmunity, chronic infectious diseases and cancer, today announced the dosing of the first patient in the PCA001 clinical trial (NCT05617040). PCA001 is a multi-centre, Phase 1/2 clinical trial designed to determine the recommended Phase 2 regimen and evaluate the safety, efficacy, as measured by prostate-specific antigen (PSA) response, and T cell response of VTP-850 monotherapy in men with rising PSA after definitive local therapy for their disease (i.e., biochemical recurrence). VTP-850 is a next-generation prostate cancer immunotherapeutic candidate which utilizes Vaccitech’s sequential dosing approach of two proprietary nonreplicating viral vectors, ChAdOx and MVA. PCA001 builds on the previous promising data from the University of Oxford VANCE01 (NCT02390063) and ADVANCE (NCT03815942) trials, Phase 1 and Phase 1/2 clinical trials respectively, of VTP-800, the first-generation product candidate which encoded 5T4, an antigen expressed by most prostate cancers.1,2 VTP-850 is a multi-antigen immunotherapeutic candidate containing four prostate-associated antigens: PSA, PAP, STEAP1 and 5T4. The first phase of the trial is enrolling participants in the US, with plans to open further sites in Italy and Spain. “20-40% of patients will unfortunately experience biochemical recurrence following initial local therapy for prostate cancer with the potential to experience metastases.3 VTP-850 is our next-generation, multi-antigen product candidate designed to induce a targeted polyclonal T cell response to kill remaining tumor cells and prevent advancement to metastatic disease,” said Bill Enright, Chief Executive Officer of Vaccitech. “We saw very encouraging data from the VANCE01 and ADVANCE trials, and we are excited to begin PCA001 where VTP-850 will be evaluated as a monotherapy in a patient population with important unmet medical needs.” “VTP-850 encodes four prostate cancer antigens and is designed to induce a broader T cell response to tumor cells,” said Dr. Meg Marshall, Chief Medical Officer of Vaccitech. “When the immune system targets multiple molecules on tumor cells, it is generally harder for tumor cells to escape destruction by the immune system.” About Prostate Cancer In 2020, prostate cancer was the fourth most common cancer worldwide, with 1.4 million new cases diagnosed.4 In the US, out of every 100 American men, about 13 will get prostate cancer during their lifetime.5 In the UK, prostate cancer is the most common cancer in men, with more than 52,000 people diagnosed with the disease on average each year.6 20-30% of patients experience rising levels of PSA after local therapy (e.g. prostatectomy), indicating that disease was not cured by local therapy.7 Of men who do experience biochemical recurrence, there is a 1 in 9 chance of developing metastases.8 About Vaccitech Vaccitech is a clinical-stage biopharmaceutical company focused on the development of novel T cell immunotherapeutics designed to harness the power of the immune system to treat and cure chronic infectious diseases, autoimmune diseases, and cancer. The Company stands apart through a proprietary, multi-platform approach that has shown the ability to induce higher magnitudes of T cells compared with other technologies. Vaccitech is uniquely positioned to address the needs of large, underserved patient populations through a diverse clinical-stage pipeline of investigational therapies targeting diseases that pose significant public health risk and have limited treatment options. The Company’s lead product candidates include VTP-300, an immunotherapy product candidate designed as a component of a potential functional cure for chronic hepatitis B viral (HBV) infection; VTP-200, a non-invasive, early-stage investigational treatment for persistent, high-risk human papillomavirus (HPV) infection; VTP-850, a novel T cell investigational therapy for prostate cancer; and VTP-1000, a preclinical T cell therapeutic candidate designed to restore immune tolerance in celiac disease. Vaccitech has proven drug development and scientific expertise in the field of immunization, co-inventing a COVID-19 vaccine with the University of Oxford, which is now approved and exclusively licensed worldwide to AstraZeneca. For more information, visit www.vaccitech.co.uk. Forward Looking Statements This press release contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “intend,” “promising,” “believe,” “potential,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding: the Company’s plans and strategy with respect to VTP-850 and the PCA001 clinical trial, including plans for patient enrollment in Italy and Spain, the potential benefits of VTP-850 for the treatment of prostate cancer and expected patient population of VTP-850. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of the Company’s product development activities and planned and ongoing clinical trials, the Company’s ability to execute on its strategy, regulatory developments, the Company’s ability to fund its operations, global economic uncertainty, including disruptions in the banking industry, the impact that the COVID-19 pandemic may have on the Company’s clinical trials and preclinical studies, and access to capital and other risks identified in the company’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2022, its Quarterly Reports on Form 10-Q and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. References Cappuccini. F, et al, J Immunother Cancer, 2020. DOI: 10.1136/jitc-2020-000928Tuthill, M, et al, Ann. Oncol. 2020. DOI: https://doi.org/10.1016/j.annonc.2020.08.2076Artibani, W, et al, Urol Int, 2017. DOI: https://doi.org/10.1159/000481438WHO, Cancer, 2022.CDC, Prostate Cancer, 2022.Prostate Cancer UK, About Prostate Cancer, 2022.Johns Hopkins Medicine, Prostate Cancer Prognosis, 2023.Stensland. KD, et al, J Clin Onc, 2022. DOI: 10.1200/JCO.2022.40.16_suppl.5090 IR contacts: Christopher M. Calabrese  Managing Director  LifeSci Advisors 917-680-5608 ccalabrese@lifesciadvisors.com  Kevin Gardner Managing Director LifeSci Advisors 617-283-2856 kgardner@lifesciadvisors.com     Media contact: Mike Beyer SAM BROWN, INC 312-961-2502 mikebeyer@sambrown.com       Company contact: Jonothan Blackbourn IR & PR Manager Vaccitech IR@vaccitech.co.uk

China’s JW Therapeutics, which was co-founded by Juno Therapeutics and Wuxi AppTec, forged a partnership with Thermo Fisher Scientific to ensure non-exclusive commercial access to Thermo Fisher’s Gibco CTS Dynabeads CD3/CD28. The exclusive agreement will be used to support JW’s clinical development programs for CAR-T (Chimeric Antigen Receptor T-Cells) therapies in China. The deal includes JW Therapeutics’ lead product relmacabtagene autoleucel (relma-cel), which is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory B-cell lymphoma. The therapy’s new drug application has been accepted by China's National Medical Products Administration. Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China. The CTS Dynabeads platform is part of Thermo Fisher’s proven Cell Therapy Systems (CTS) product portfolio designed to ease the transition from clinical development to commercial manufacturing of T-cell therapies. Thermo Fisher’s Gibco CTS Dynabeads provide a scalable platform to streamline therapy development and production while ensuring highly reproducible results. “This partnership is a natural extension of an already strong collaboration,” Harry Lam, chief technology officer at JW Therapeutics said in a statement. “As we approach critical milestones in our commercialization strategy, this partnership will ensure we have the supply to scale up and meet the unmet medical needs of Chinese patients.” Elsewhere around the globe: Indegene – India-based Indegene announced the Carlyle Group and Brighton Park Capital have acquired a minority stake in the company with a $200 million investment. The transaction consists of a secondary sale from existing shareholders of Indegene and a primary investment into the company. Indegene plans to use the primary investment from Carlyle and Brighton Park to accelerate its M&A and global expansion plans. Over the last decade, Indegene has made significant organic and inorganic investments in building a technology portfolio that caters exclusively to healthcare. This growth rate is accelerating with strong industry tailwinds driving a rapid shift towards digital-first operations, the company said. Vaccitech – Based in Oxford, Vaccitech announced the dosing of the first patient in HBV002, a Phase Ib/IIa clinical trial designed to evaluate the safety and preliminary efficacy of VTP-300 both with and without a low-dose anti-PD-1 antibody in patients with chronic hepatitis B (CHB) infection. The study plans to enroll 64 patients in South Korea, Taiwan and the U.K. VTP-300 will utilize Vaccitech’s ChAdOx1-MVA prime-boost combination to elicit an immune response against HBV. The platform has demonstrated robust activation of cytotoxic CD8+ T cells (immune cells associated with clearance of HBV infected cells), which are believed to have the potential to lead to a functional cure in combination with current anti-viral therapy and a low-dose checkpoint inhibitor. Cytiva – U.K.-based Cytiva has acquired Canada’s Vanrx Pharmasystems, the first such deal struck by the company. The Vanrx portfolio complements Cytiva's manufacturing capacity solutions. Vanrx makes robotic aseptic filling machines to fill vials, syringes, and cartridges with reduced risk and increased speed to patients. Vanrx's flagship products are the SA25 Aseptic Filling Workcell and Microcell Vial Filler, which automate aseptic filling using robotics within closed, gloveless isolators. These standardized, flexible systems provide a fast and certain path to filling capacity as the final step in manufacturing clinical and commercial biopharmaceuticals. Adagene – China’s Adagene and Exelixis, Inc. announced a collaboration and license agreement that will allow Exelixis to use Adagene’s SAFEbody technology platform to generate masked versions of monoclonal antibodies from Exelixis’ growing preclinical pipeline for the development of ADCs or other innovative biologics against Exelixis-nominated targets. Under the terms of the agreement, Exelixis will make an upfront payment of $11 million to Adagene and will have the ability to nominate two targets during the collaboration term. Adagene will be eligible for development and commercialization milestones, as well as royalties on net sales of products developed around each of these targets. Follicum AB – Sweden-based Follicum announced the conclusion of dosing in its Phase IIa study assessing FOL-005 for the treatment of hair loss associated with alopecia. Top line results are expected to be presented during spring 2021. The ongoing double-blind and placebo-controlled Phase IIa study examines the safety and efficacy of FOL-005 in a new, cream-like formulation. The patients themselves have applied one of three different strengths of FOL-005 or placebo to the scalp once a day and have undergone follow-up at regular visits to the study clinics during the four months of the study. Two previous clinical studies with FOL-005 have shown that treatment with intradermal injections of the drug candidate is effective and safe for stimulation of hair growth. Elypta – Also based in Sweden, Elypta received a patent from the United States Patent and Trademark Office for its novel liquid biopsy method for cancer diagnostics. The patent concerns a method for screening for renal cell carcinoma, the most common form of kidney cancer, by measuring specific metabolites – glycosaminoglycans (GAGs) – non-invasively, through for example blood or urine samples. In addition to its patent, Elypta launched the first standardized testing service based on a RUO liquid biopsy for full spectrum glycosaminoglycan quantification for researchers. Elypta is also launching a sponsorship program to support more academic research in the field, prioritizing fundamental, pre-clinical, and clinical questions about how glycosaminoglycans relate to cancer. Using Elypta’s service, researchers will now be able to send serum, plasma, urine, cell cultures, and other tissue specimens to Elypta laboratories and receive a standardized quantification of the full GAG profile. Avacta Group – U.K.-based Avacta Group plc announced its subsidiary, AffyXell Therapeutics, which is a joint venture with Korea-based Daewoong Pharmaceutical, closed a Series A financing round with $7.3 million to further develop its pipeline of next generation cell and gene therapies. AffyXell was established in January 2020 by Avacta and Daewoong as a Joint Venture to develop novel mesenchymal stem cell (MSC) therapies. AffyXell is combining Avacta’s Affimer platform with Daewoong’s MSC platform such that the stem cells are genetically modified to produce and secrete therapeutic Affimer proteins in situ in the patient. The Affimer proteins are designed to enhance the therapeutic effects of the MSC creating a novel, next generation cell therapy platform. The capital raised will be used by AffyXell to further the development of MSCs engineered to produce Affimer molecules generated by Avacta that suppress immune response and restore immune balance. While initially focusing on inflammatory and autoimmune diseases and prevention of organ transplant rejection, longer term goals could also include applications in regenerative medicine, infectious diseases and oncology. Ilya Pharma – Based in Sweden, Ilya Pharma announced it received a patent from the European Patent Office. The patent, titled “Methods for Wound Healing,” covers the use of the lactic acid bacteria Lactobacillus reuteri, which have been transformed with a plasmid capable of expressing a wound healing protein selected from CXCL12, CXCL17 and Ym1 to heal cutaneous wounds in humans and animals. Recipharm AB – Netherlands-based Recipharm and Medspray BV have completed the establishment of Resyca BV, which will develop and exploit the softmist spray nozzle technology for pharmaceutical applications. This has the potential to eliminate the need for propellants by delivering therapies deep into the lungs more effectively with lower doses as less ends up in the mouth and throat. Recipharm will receive an exclusive license to offer its customers the development and manufacturing of syringe-based devices using the softmist nozzle technology. ProBioGen AG – Germany’s ProBioGen and China’s Harbour BioMed partnered on a cell line development project and application of the ADCC-enhancement technology GlymaxX. The GlymaxX technology enables flexible and reversible adjustment of the antibody fucosylation level – from afucosylated to fully fucosylated. Gedea Biotech – Based in Sweden, Gedea Biotech has enrolled the first patient in the NEFERTITI clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). The randomized double-blind placebo-controlled study is designed to confirm safety and efficacy of pHyph and is coordinated by Nottingham University NHS Hospitals Trust in the U.K. BD – BD (Becton, Dickinson and Company) announced the CE mark of BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with expanded clinical application to help clinicians identify COVID-19 patients at increased relative risk of intubation with mechanical ventilation (IMV) and mortality at hospital admission, in conjunction with clinical findings and the results of other laboratory testing. Mutabilis– France-based Mutabilis received $6.4 million in funding from CARB-X to develop a new class of antibacterials to treat infections caused by Carbapenem-resistant Enterobacterales (CRE) bacteria. CRE has been dubbed the “nightmare bacteria” by health officials because they cause deadly infections – often in healthcare settings - that cannot be effectively treated with existing antibiotics. Under the award agreement, Mutabilis will be eligible for an additional $5.8 million in further funding if certain project milestones are met, subject to available funds. Mutabilis’ new intravenous drug, EBL-1463, is a novel class of non-beta-lactam inhibitor of penicillin binding proteins (PBPs) called dabocins. It kills bacteria in the same efficient way as beta-lactams – by interfering with the cell wall synthesis of the bacteria. Contrary to beta-lactams, however, EBL-1463 shows unmatched stability to class A, B, C and D beta-lactamases. The project is in the preclinical phase.