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www.fdanews.com/articles/200283-regeneron-and-upenn-forge-gene-therapy-pact-for-covid-19-antibody-cocktail

Regeneron and UPenn Forge Gene Therapy Pact for COVID-19 Antibody Cocktail

December 3, 2020

Regeneron has partnered with the University of Pennsylvania (UPenn) to develop a gene therapy nasal delivery system for its COVID-19 antibody cocktail, casirivimab and imdevimab, which received an Emergency Use Authorization from the FDA last month for mild-to-moderately ill coronavirus patients at high risk.

The collaboration aims to use adeno-associated virus (AAV) vectors to deliver the gene therapy.  Regeneron’s antibody therapy, REGN-COV2, is currently delivered via intravenous infusion, but the New York-based drugmaker is exploring alternative delivery methods.

“The advantage of AAV in this application is that it can achieve sustained expression of the antibodies in the nasal mucosa, which is the site of infection, following a single administration,” said UPenn’s lead researcher James Wilson.

“In contrast to traditional vaccines, AAV delivery of antibodies provides a rapid onset of response and no reliance on the need for the recipient to mount an immune system response over time,” Wilson said, adding that this may be especially useful for individuals with weakened immunity or frontline healthcare professionals who need rapid protection.

HHS began shipping the antibody cocktail across the U.S. last week and it hopes to distribute enough to treat approximately 300,000 patients by the end of January 2021 (DID, Nov. 24). ― Jason Scott