Regeneron Pharmaceuticals have announced that the Biomedical Advanced Research and Development Authority (BARDA) has entered into an agreement with Regeneron to support clinical development, clinical manufacturing and the regulatory licensure process of a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection. The agreement is part of ‘Project NextGen,’ an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19.
BARDA, part of the Administration for Strategic Preparedness and Response at HHS, and Regeneron have previously worked together to deliver novel medicines for Ebola and COVID-19 at unprecedented speed and under urgent circumstances. The new program announced today falls under Regeneron and BARDA’s ongoing Other Transactions Agreement initiated in 2017 to develop a portfolio of antibodies targeting up to 10 pathogens that pose significant risk to public health. For the new COVID-19 program, HHS will fund up to 70 percent of Regeneron’s costs for certain clinical development activities for a next-generation monoclonal antibody therapy with broad neutralising activity against SARS-CoV-2, the virus that causes COVID-19. The new contract has an estimated value of up to approximately $326 million of government funding.
“We’re pleased to expand our longstanding BARDA relationship, which is predicated on Regeneron’s decades of investment in deep scientific research and enabling technologies,” said Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron. “Although COVID-19 has moved to an endemic stage, many people – including those with immunocompromising conditions – continue to face exposure that impacts their everyday life and could cause serious health consequences. We believe Regeneron can once again apply our drug discovery and development expertise to help prevent disease in vulnerable populations. American biopharmaceutical companies developed remarkable COVID-19 therapeutics and vaccines in record time, successfully changing the course of the pandemic, and we’re gratified that the U.S. Government continues to support early research from this uniquely innovative industry.”
Under the project structure, Regeneron independently invents and proposes an antibody candidate, which BARDA and Regeneron will then evaluate and agree upon for further development, manufacturing and regulatory activities. Regeneron’s most advanced next-generation antibody candidate under this agreement is expected to enter clinical trials later this year.