Vaccitech Presents Interim Data from Phase 1b/2 Study of VTP-200 at 35th Annual International Papillomavirus Conference (IPVC) Highlighting Favourable Tolerability and Immunogenicity Profile
pharmafile | April 17, 2023 | News story | Business Services |
OXFORD, United Kingdom, April 17, 2023 (GLOBE NEWSWIRE) – Vaccitech plc (NASDAQ: VACC), 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, will present topline data from the APOLLO clinical trial at the 35th Annual International Papillomavirus Conference (IPVC). The APOLLO trial (also known as HPV001) is a fully enrolled Phase 1b/2 study of VTP-200 in women with low-grade cervical lesions associated with persistent human papillomavirus (HPV) infection. The data will be presented as a poster at IPVC in Washington, D.C. on Thursday, April 20, 2023 at 2 PM EDT, by Dr. Meg Marshall, Chief Medical Officer of Vaccitech.
“The safety and immunogenicity data presented at IPVC shows the potential of VTP-200 in treating persistent high-risk HPV (hrHPV) infections. Currently, women with persistent HPV infections have no treatment options until they develop high grade lesions,” said Meg Marshall, CMO of Vaccitech. “We believe VTP-200 has the potential to address a serious unmet need and look forward to sharing the results of the final analysis, to include data on clearance of infection and cervical lesions, in 2024.”
The poster shows data for 42 women at Day 35, 7 days after the last dose of VTP-200, split by active treatment versus placebo. VTP-200 was generally well-tolerated and was administered with no product-related grade 3 unsolicited adverse events and no product-related SAEs. While the placebo group showed no antigen-specific T cell responses as measured by IFNg ELISpot, 26 of 29 women receiving varying doses of VTP-200 showed a response. The pooled active groups showed meaningful responses, with the average being greater than 1,000 spot-forming units per million peripheral blood mononuclear cells. Responses were strongest to the E1, E2 and E6 antigens. In addition, intracellular cytokine staining data from the active groups showed both CD4 and CD8 responses.
About APOLLO (HPV001)
APOLLO (NCT04607850) is a fully-enrolled, randomized, placebo-controlled Phase 1b/2 multi-center trial evaluating the safety, immunogenicity and efficacy of VTP-200, which utilizes the ChAdOx1-HPV and MVA-HPV combination approach in women with persistent HPV infection and low grade cervical lesions. The primary objective is to evaluate the safety and tolerability of VTP-200. The trial is also designed to determine the effect of VTP-200 on the hrHPV infection and lesion(s), as well as select the appropriate dose for further development. The study consists of an open label, non-randomized, dose escalation lead-in phase of 9 women, followed by a blinded, randomized main phase of approximately 96 women with high-risk HPV.
About VTP-200
VTP-200 is an investigational immunotherapeutic combination regimen consisting of an initial dose using the ChAdOx vector and a second dose using MVA, both encoding the same HPV antigens (i.e.: E1, E2, E4, E5, E6, E7), designed to elicit an antigen-specific T cell immune response to HPV. VTP-200 is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated pre-cancerous lesions.
About HPV
It is estimated that approximately 291 million women worldwide are carriers of human papillomavirus DNA.1 Persistent genital HPV infection is responsible for almost all cases of cervical pre-cancerous lesions, which can lead to cervical carcinoma.2 Over 95% of cervical cancers are caused by HPV infection.2 Cervical cancer was the fourth most common cancer in women in 2020, with approximately 604,000 cases and 342,000 deaths from the disease worldwide.2 The American Cancer Society predicts that in 2023, approximately 13,960 new cases of invasive cervical cancer will be diagnosed in the US with over 4,310 women dying from the disease.3
About Vaccitech
Vaccitech is a clinical-stage biopharmaceutical company focused on the development of novel T cell immunotherapeutics designed to utilize 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 life-threatening diseases that pose significant public health risk and have limited treatment options. The company’s lead product candidates include VTP-300, an immunotherapy 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); VTP-850, a novel T cell investigational therapy for prostate cancer; and VTP-1000, a preclinical T cell therapeutic candidate for 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.
