OXFORD, UK I June 12, 2023 I 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
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:
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.”
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
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
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.