- Pharmaceutical company Regeneron was granted $326 million to work with BARDA to develop and manufacture a monoclonal antibody for people who can’t take or don’t respond to current vaccines.
- Clinical trials are expected to begin this fall.
- Regeneron developed the monoclonal antibody therapy known as REGEN-COV (casirivimab and imdevimab) during the early parts of the COVID-19 pandemic, at one point being the only treatment available for the virus.
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.
As part of Project NextGen, HHS has awarded more than $1.4 billion in grants to support the development of the next generation of COVID-19 vaccines and technologies.
“As the virus continues to evolve, we need new tools that keep pace with those changes,” Dawn O’Connell, the U.S. Department of Health and Human Services Assistant Secretary for Preparedness and Response, said in a statement Tuesday.
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. 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 neutralizing 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. 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.Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron.
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.
Starting in early 2020, Regeneron scientists rapidly responded to the COVID-19 pandemic by discovering and manufacturing a highly potent, anti-spike antibody cocktail that successfully neutralized many SARS-CoV-2 variants, including Delta. Developed at record speed and first granted Emergency Use Authorization in November 2020, the antibody cocktail was used as a COVID-19 treatment and preventative for millions of people around the globe, with nearly 3 million doses delivered to the U.S. Government between 2020 and 2022.
The next-generation antibody project is being funded in part with federal funds from BARDA under OT number: HHSO100201700020C.