TARRYTOWN, N.Y., June 11, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Science has accepted for publication two papers describing the creation of its novel two-antibody cocktail, REGN-COV2, and its potential to diminish risk of viral escape by effectively binding to the virus's critical spike protein in two separate, non-overlapping locations. The publications will be available online on Monday. Regeneron also announced today that REGN-COV2 has entered human clinical trials.

"Our work inventing novel antibodies has shown that individual antibodies, no matter how good, are likely not enough against the devastating virus that causes COVID-19 and the ways it seeks to 'escape' being neutralized," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer at Regeneron. "The concept that drug cocktails can prevent viral escape has previously been demonstrated for traditional antiviral drugs used to treat HIV and other viruses. We now report the fundamental realization that this can also be true for antibody-based therapies, supporting our hope that our REGN-COV2 cocktail can be a potent weapon against COVID-19 while preventing the emergence of viral drug-resistance." 

The first paper entitled "High-Throughput Effort Using Both Humanized Mice and Convalescent Humans Yields SARS-CoV-2 Antibody Cocktail" describes Regeneron's parallel efforts using both humanized VelocImmune® mice and blood samples from recovered COVID-19 patients to generate a large and diverse collection of antibodies targeting multiple different regions of the critical receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. The spike protein on the virus cell surface binds to the host cell and is required for infectivity. By blocking its interaction with the host cell, antibodies are able to neutralize the virus and block infection. Regeneron scientists selected pairs of highly potent individual antibodies that simultaneously and non-competitively bind to the RBD. Regeneron pursues a multi-antibody cocktail approach for infectious diseases in order to decrease the potential for the virus to escape.

Viral escape is when, under pressure from an anti-viral therapeutic, spontaneously arising mutant forms of the virus are able to 'escape' or evade the therapeutic's blocking action. These mutants are then 'selected' (i.e., are able to survive and proliferate despite the single therapeutic treatment) and may ultimately become the dominant strain of the virus.

The concept that drug cocktails can prevent viral escape has previously been demonstrated for traditional antiviral drugs used to treat HIV and other viruses. Regeneron now reports the fundamental realization that this can also be true for antibody-based therapies as reported in the second paper, entitled "Antibody Cocktail to SARS-Cov-2 Spike Protein Prevents Rapid Mutational Escape Seen with Individual Antibodies," which further defines the protective value of the multiple-antibody approach against SARS-CoV-2 specifically. This research for the first time demonstrates that, under pressure from individual antibodies, mutant viruses were rapidly selected that evaded the blocking function of all individual antibodies tested, including antibodies that potently bind to highly-conserved regions on the spike protein. However, escape mutants could not be efficiently generated following exposure to the REGN-COV2 cocktail since it utilizes two antibodies that can simultaneously bind to distinct regions of the RBD.

"Our manuscripts describe the results of a cross-functional, comprehensive study, aiming to generate, isolate, select and functionally characterize human antibodies against SARS-CoV-2. We previously used the same technologies and cocktail approach to develop REGN-EB3, a novel triple antibody treatment for Ebola that demonstrated safety and efficacy versus the standard of care in a clinical trial in the Democratic Republic of Congo," said Christos Kyratsous, Ph.D., Vice President of Research, Infectious Diseases and Viral Vector Technologies at Regeneron. "We hope to see similar success with this program and help improve outcomes against this terrible disease."

REGN-COV2's preclinical development and preclinical/clinical manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, under OT number: HHSO100201700020C.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses a unique genetically-humanized mouse to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

SOURCE Regeneron Pharmaceuticals, Inc.

Posted: June 2020