REGEN-COV R&D Team
Robert Babb, Senior Director, Cell Technologies
Ashok Badithe, Director, Therapeutic Antibodies
Alina Baum, Associate Director, Infectious Disease
Jonathan Cruz, Scientist
Ben Fulton, Scientist
Johanna Hansen, Director, Cell Technologies
Annabel Romero Hernandez, Scientist
(In the photo above: First row: Alina Baum, Annabel Romero Hernandez, and Ashok Badithe. Second row: Ben Fulton, Johanna Hansen, Jonathan Cruz, and Robert Babb.)
A Life-Saving Antibody Cocktail
As COVID-19 continues to consume the globe, scientists work tirelessly to find treatments to slow its spread and save lives. The REGEN-COV R&D Team at Regeneron delivered on that goal. Comprising two antibodies, casirivimab and imdevimab, REGEN-COV is one of a few treatments that’s received emergency use authorization from FDA—making the journey from early-stage research to authorization in just 10 months.
But the journey began not with treating COVID, but Ebola. In December 2019, the team was celebrating groundbreaking trial results that found their then-investigational triple-antibody cocktail gave Ebola patients a safe and efficacious treatment option where none existed. A few weeks later, SARS-CoV-2 started to spread and they asked, “How can we help?”
The scientists tapped Regeneron’s VelociSuite® technologies, including its VelocImmune® mice that are genetically modified to have human immune systems, to isolate potent virus-neutralizing antibodies. In identifying casirivimab and imdevimab, they found two antibodies that bind non-competitively to the critical receptor binding domain of the novel coronavirus’ Spike protein, which aims to diminish the ability of mutant viruses to escape treatment. As this virus continues to mutate and new variants appear, this approach may be critical.
The team moved into human trials after an unprecedented five months. Regeneron had already begun maximizing manufacturing capacity in the hopes the treatment would prove safe and effective. They collaborated with Roche to expand global manufacturing capacity, and established an agreement with the U.S. for potential purchase of over 1.5 million doses.
The cocktail is currently authorized for treatment of high-risk patients with mild-to-moderate COVID-19. In a Phase 3 trial in non-hospitalized patients, the treatment showed a reduction of hospitalization and death by 70%. Furthermore, the latest Phase 3 data evaluated its use in the prevention setting, showing REGEN-COV reduced the risk of symptomatic infection by 81%. This suggests the cocktail is a vital tool to complement widespread vaccination strategies, and Regeneron is currently seeking FDA approval to expand their indication to include COVID prevention.
The team continues trials to find more ways to help ease this pandemic.