Oxford, UK – Vaccitech Ltd, a clinical-stage T cell immunotherapy company developing products to treat cancer and chronic infectious diseases, announces top line Phase 2 data and plans for its recombinant Modified Vaccinia Ankara (MVA) Universal Influenza A prophylactic vaccine, VTP-100, clinically developed to address both pandemic and seasonal influenza.
A Data Monitoring Committee (DMC) performed an unblinded analysis of interim results from FLU009, a single-blind, randomised, placebo-controlled field Phase 2b trial for seasonal influenza with 2,149 participants, sponsored in Australia by Vaccitech’s wholly-owned subsidiary, Vaccitech Australia Pty Limited. The DMC recommendation is that the trial should not be continued for a second season. The committee’s analysis indicates that while the vaccine was safe and well tolerated, the trial is unlikely to meet the primary endpoint and achieve the required level of reduction in the incidence of laboratory-confirmed influenza in participants receiving VTP-100 as an add-on to a licenced seasonal Quadrivalent Influenza Vaccine (QIV), relative to participants receiving QIV alone.
In addition, data from FLU010, a randomised, double-blind, placebo-controlled, influenza challenge Phase 2 trial for pandemic influenza in 118 healthy adults did not reach its primary endpoint of a thirty percent reduction in overall viral shedding. Vaccitech will continue its obligations under the contract with BARDA to analyse potential immunological correlates associated with protection or risk from disease. The trial was conducted under review by both the FDA and the Belgian Regulatory Authority, FAMHP.
Bill Enright, CEO of Vaccitech, commented on the results, “While we are disappointed that our MVA-based VTP-100 prophylactic vaccine did not reach its Phase 2 clinical objectives, we remain excited at the prospect of advancing our therapeutic programs in infectious disease and oncology. This year we anticipate Phase 2a results from our Prostate Cancer therapeutic and will initiate Phase 1/2 trials to assess immunotherapeutic products developed from our heterologous, prime-boost ChAdOx and MVA platform designed to induce T cells targeting HPV, HBV and Non-Small Cell Lung Cancer (NSCLC).”
The FLU010 clinical study has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201900013C.