CAMBRIDGE, Mass.--(BUSINESS WIRE)--Visterra, Inc., a clinical-stage biotechnology company that uses its proprietary technology platform to identify unique disease targets and design novel therapeutics for infectious diseases, today announced that the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) has awarded Visterra a five-year contract valued at up to $204.5 million for the development of VIS410, Visterra’s novel monoclonal antibody in development for the treatment of seasonal and potential pandemic influenza A.
“We are pleased that BARDA has awarded this contract covering the development of VIS410,” said Brian Pereira, MD, President and Chief Executive Officer of Visterra. “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. This award from BARDA will support the continued development of VIS410, our lead product candidate, which was designed and engineered using our proprietary technology platform.”
The BARDA contract includes funding for performing pre-clinical 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.
The contract includes a 40-month base period with committed funding of $29.1 million and option periods that, if exercised in full by BARDA, would extend the contract to a total of 5 years and increase the total funding up to $204.5 million. The full funding, if received, will support Visterra’s plans to submit a Biologics License Application (BLA) for VIS410 to the U.S. Food & Drug Administration (FDA).
This project has been funded in whole or 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. HHSO100201500018C.
VIS410 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. Visterra is developing VIS410 as a single administration treatment for hospitalized patients with influenza A infection, including seasonal and potential pandemic strains.
Influenza virus infection is one of the most common infectious diseases and can lead to severe illness and death. Influenza epidemics occur seasonally in most countries, resulting in about three to five million cases of severe illness and about 250,000 to 500,000 deaths worldwide. Although the usual strains of influenza that circulate annually are of a significant public health concern, far more lethal influenza strains have emerged periodically, leading in some cases to pandemics. Recently, both H5N1 and H7N9 isolates have emerged in humans, causing severe disease with high mortality, although to this point only limited human-to-human transmission has been observed. Nonetheless, predicted mutations in both H5 and H7 strains have the potential to enhance human-to-human transmission and create pandemic potential. In addition, data that H7N9 strains are more readily transmitted from poultry to humans compared to other avian influenza viruses, and documentation of resistance of H7N9 to existing anti-viral drugs, have fueled increased concern.
Visterra is a biotechnology company that uses its proprietary Hierotope™ Platform to identify unique disease targets and design and engineer effective therapeutics. The company’s technology is powered by computational tools and techniques, the core of which is Atomic Interaction Network (AIN) analysis, which identifies a specific area, or epitope, on the target site that is fundamental to its structure and function. This ideal epitope, or hierotope, becomes the target against which the company designs a novel therapeutic with the potential to effectively and durably combat the disease. The company is currently focused on therapeutics for infectious diseases, and its lead product candidate, VIS410, is a broad spectrum human monoclonal antibody for the treatment of both seasonal and pandemic influenza. The company’s second product candidate, VIS513, is a human monoclonal antibody for the treatment of dengue that has been shown to broadly neutralize all four dengue virus serotypes. Visterra was founded based on scientific work developed in the laboratory of Dr. Ram Sasisekharan and licensed from MIT. For more information, please visit www.visterrainc.com.