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Visterra Wins Up-to-$204.5M BARDA Contract; Reports Positive Phase IIa Results
Visterra said today it has won a five-year, up-to-$204.5 million contract from the Biomedical Advanced Research and Development Authority (BARDA) toward the development of the company’s Phase IIa lead product candidate VIS410 for seasonal and potential pandemi
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Visterra said today it has won a five-year, up-to-$204.5 million contract from the Biomedical Advanced Research and Development Authority (BARDA) toward the development of the company’s Phase IIa lead product candidate VIS410 for seasonal and potential pandemic influenza A.
The BARDA contract includes funding for performing preclinical toxicology studies, conducting clinical trials, manufacturing of materials for clinical trials and continued optimization of manufacturing processes, and associated regulatory activities intended to advance VIS410, Visterra said.
Separately, Visterra also said today that it intends to advance VIS410 into further clinical trials in patients with influenza A, after the compound showed a statistically significant viral response over placebo in a Phase IIa influenza viral challenge study, and achieved its primary endpoint of reduction in viral shedding.
Subjects treated with VIS410 experienced a 92% reduction in viral shedding and resolved upper respiratory symptoms two days earlier than subjects in the placebo group. The primary endpoint was achieved after a pre-specified interim analysis, and as a result, Visterra said, it has stopped the comparative portion of the study.
VIS140 is a broad spectrum human monoclonal antibody designed and engineered to neutralize all strains of influenza A, including mutated strains and strains that have recently emerged. VIS410 is a direct acting anti-viral that inhibits hemagglutinin-mediated cell membrane fusion, thereby preventing viral replication.
Through its Hierotope Platform to identify novel targets and engineer drugs against these targets, Visterra has identified a conformational epitope on the stem region of the influenza hemagglutinin protein. According to the company, this epitope, or hierotope, is not only conserved across all influenza subtypes, but is also resistant to virus mutation.
Visterra said it is developing VIS410 as a single administration treatment for hospitalized patients with influenza A infection, including seasonal and potential pandemic strains.
The BARDA contract includes a 40-month base period with committed funding of $29.1 million, as well as option periods that, if exercised in full by BARDA, would extend the contract to a total of five years and increase the total funding up to $204.5 million. The full funding would support Visterra’s plans to submit a Biologics License Application for VIS410 to the FDA.
“Visterra is proud to play an important role in addressing the significant public health concern of seasonal influenza A and the growing threat of emerging strains of influenza A,” Brian J.G. Pereira, M.D., the company’s president and CEO, said in a statement.
Based in Cambridge, MA, Visterra was founded based on scientific work developed in the laboratory of Ram Sasisekharan, Ph.D., and licensed from MIT.
The BARDA contract comes a year to the month that Visterra won $30 million in Series B financing to advance the development of VIS410 and a second product candidate, VIS513, a human monoclonal antibody for dengue that has been shown to broadly neutralize all four dengue virus serotypes.
The financing was co-led by new investors Merck Research Labs Venture Fund, Vertex Venture Holdings Ltd., and Temasek, with participation by another new investor, Cycad Group, and previous investors Polaris Partners, Flagship Ventures, Omega Funds and Alexandria Venture Investments. The previous investors joined The Bill & Melinda Gates Foundation in a $26 million series A financing in 2012.