On Apr. 16, 2020, Regeneron announced the U.S. Food and Drug Administration (FDA) had accepted for Priority Review a new Biologics License Application for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection. The target action date for the FDA decision was October 25, 2020.

The REGN-EB3 BLA is supported by data from the randomized, controlled PALM clinical trial conducted in the Democratic Republic of Congo. In August 2019, the trial was stopped early when preliminary results showed that REGN-EB3 crossed the pre-specified superiority threshold for preventing death compared to the control arm, ZMapp. REGN-EB3 demonstrated superior efficacy compared to ZMapp across multiple measures, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream.

Regeneron’s VelociSuite technologies enable the efficient creation and selection of potent fully-human antibodies against a specific biological target, which is particularly critical for addressing new and/or quickly-spreading pathogens that cause diseases such as Ebola and COVID-19. These technologies facilitate the rapid cloning and generation of optimized fully-human antibodies from both VelocImmune^® mice (which are genetically-engineered to have genetically-humanized immune systems) and convalescing human volunteers, and allow for the rapid escalation of fully-human antibodies into manufacturing-quality cell line production and large-scale bioreactor manufacturing. Once strong therapeutic antibody candidates are identified, the company’s in-house preclinical, clinical and commercial-scale manufacturing capabilities allow for fast scale-up and flexibility to adapt to current need.

REGN-EB3 had received Orphan Drug and Breakthrough Therapy designation from the FDA. It is being developed under an ongoing collaboration and with funding provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, their 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. Their medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.