Regeneron has identified hundreds of virus-neutralizing antibodies; plans to initiate large-scale manufacturing by mid-April with antibody cocktail therapy
Potential to enter human clinical studies by early summer
This program is in addition to Regeneron’s separate ongoing clinical program evaluating Kevzara® (sarilumab, an IL-6 receptor antibody) in severe COVID-19 patients
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the latest progress in its efforts to discover and develop a novel multi-antibody cocktail that can be administered as prophylaxis before exposure to the SARS-CoV-2 virus or as treatment for those already infected. Regeneron scientists have now isolated hundreds of virus-neutralizing, fully human antibodies from the company’s VelocImmune® mice, which have been genetically-modified to have a human immune system. Regeneron has also isolated antibodies from humans who have recovered from COVID-19, in order to maximize the pool of potentially potent antibodies. From this large pool of candidates, Regeneron will select the top two antibodies for a ‘cocktail’ treatment based on potency and binding ability to the SARS-CoV-2 spike protein, as well as other desirable qualities. Using a multi-antibody approach allows for targeting of different parts of the virus and may help protect against multiple viral variants. Regeneron previously used these technologies to rapidly develop a successful treatment for Ebola virus infection, which is currently under review by the U.S. Food and Drug Administration.[su_spacer size=”10″][su_spacer size=”10″]
In order to meet the pressing public health need, Regeneron is applying its VelociMab® technology to prepare manufacturing-ready cell lines as lead antibodies are selected, so that clinical-scale production can begin immediately. The company is working toward the goal of producing hundreds of thousands of prophylactic doses per month by the end of summer and hopes to have smaller quantities available for initial clinical testing at the beginning of the summer. The company is working with the U.S. Health & Human Services’ Biomedical Advanced Research and Defense Authority (BARDA) to increase capacity even further.
“Our three decades of investment in our VelociSuite antibody technologies, which accelerate and improve the traditional drug discovery process, have hopefully prepared us for this critical time and to meet this important challenge,” said George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer of Regeneron. “Given the tremendous interest and concern around the COVID-19 pandemic, we will be providing regular and transparent updates on our discovery and development programs. I want to recognize our incredible team, which is working around the clock to develop needed solutions to this global health crisis.”
All coronaviruses have a single glycoprotein on the virus surface called the spike protein, which is the protein on the virus cell surface that binds to the host cell and is required for infectivity. Regeneron’s SARS-CoV-2 antibodies will target the spike protein in order to block its interaction with the host cell, and thus neutralize the virus.
“I’m so proud to be part of this cross-company team, which delivered a novel and effective fully human antibody treatment for Ebola in record time and is making every effort to once again rise to this unprecedented challenge,” said Christos Kyratsous, Ph.D., Vice President of Research, Infectious Diseases and Viral Vector Technologies at Regeneron.
Yesterday, Regeneron and its collaborator Sanofi also announced the initiation of a Phase 2/3 clinical trial evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19. Kevzara inhibits interleukin-6 (IL-6), which may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19.