Contract includes funding to conduct one of the largest influenza A challenge studies
Vaccitech announced today that it has been awarded a contract valued at $8.5 million from the Biomedical Advanced Research and Development Authority (BARDA), a component of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, for the advanced clinical development of its recombinant Modified Vaccinia Ankara (MVA) vaccine candidate for prevention of seasonal and pandemic influenza A. Under the agreement, BARDA will co-fund Vaccitech’s Phase II clinical trial designed to test the efficacy of its novel influenza A vaccine candidate, in line with BARDA’s mission to establish long-term strategies for the control and prevention of pandemic influenza. If the clinical trial is successful, the contract could be extended so that BARDA can continue to work with Vaccitech in further developing the vaccine candidate.
“Influenza A is a perennial economic and global health burden. If our vaccine proves to control all subtypes of that virus, people the world over will benefit from the results. With BARDA backing our vaccine technology, we have the resources required to bring scientific validation to an urgently needed disease prevention approach,” said Tom Evans, Chief Executive Officer, Vaccitech.
The clinical trial will test the ability of the experimental vaccine to protect healthy adult study participants from a challenge with the A/Belgium/4217/2015 (H3N2) influenza virus strain and will commence in Q1 2019 at the SGS Life Science Services clinical site in Antwerp, Belgium. The clinical trial will include 134 study participants, 80 of which will be immunized with the candidate vaccine and then challenged with the H3N2 influenza virus, making it one of the largest influenza human challenge studies ever conducted. Analysis of the clinical and virologic data for influenza protection is expected to be completed by Q1 2020.
“Saving lives, whether during an influenza pandemic or from seasonal influenza, requires stronger and broader vaccine protection, more flexibility, and faster development than now available,” said Rick Bright, PhD, BARDA Director. “BARDA will leverage its extensive experience in successful public partnerships to advance this vaccine candidate, which could increase the breadth and duration of protection against seasonal and pandemic influenza.”
About Vaccitech’s Platform and Influenza Programme
Vaccitech’s MVA-M1+NP vaccine candidate aims to prevent pandemic and seasonal influenza by eliciting broader and more durable immune protection against all “A strains” of the virus, which cannot be achieved by traditional vaccination. The vaccine consists of MVA, a replication deficient pox viral vector that has been safely tested in thousands of patients, to generate a strong immune reaction against Matrix 1 (M1) and Nucleoprotein (NP) influenza antigens. The antigens are highly conserved between influenza A viral subtypes and their intramuscular delivery in Vaccitech’s MVA vector construct induces a
potent cell-mediated immune response intended to reduce the likelihood of developing clinical illness from influenza. The trial is the latest in a series of studies Vaccitech has conducted to advance the medical product.
Vaccitech is a spin-out company of the University of Oxford that develops vaccines to target the biggest health risks to humanity. The company holds the rights to proprietary technology refined through over twenty years of research performed at the University’s Jenner Institute, among the world’s most prestigious vaccine research centre. Vaccitech is developing a vaccine platform that can elicit an unprecedented CD8+ T cell response against clinically relevant antigenic targets. The platform is applied in numerous infectious diseases and oncology programs, and funded by partners that include Google Ventures and Sequoia China.
About HHS, ASPR, and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.