Regeneron Sarilumab Antibodies

Antibody

Research Institution

Regeneron

Description

Based on recent clinical data from studies in China with another IL-6 inhibitor, we believe there is a potential role for Kevzara® (sarilumab) in the treatment of severe and critical hospitalized patients with COVID-19. Together with our collaborators at Sanofi, we are conducting controlled clinical studies to evaluate Kevzara in this setting.

We are using our end-to-end antibody technologies to discover and develop brand new therapeutic antibodies for this disease. Our new COVID-19 drug candidate will be studied for its potential both to prevent infection and to treat people already infected with the virus.

We have produced hundreds of virus-neutralizing antibodies in our genetically-engineered mice and isolated similarly-performing antibodies from human COVID-19 survivors. In mid-April, we moved the most potent antibodies into pre-clinical and clinical-scale cell production lines. We are on track to have enough product ready to begin human testing in June, and plan to scale production to have hundreds of thousands of preventative doses or tens of thousands of treatment doses per month by the end of August. We are actively seeking ways to maximize production capacity within Regeneron and beyond.

Research Team

George D. Yancopoulos
Chief Scientific Officer
Regeneron

Project Details

Funding Sources

Project Phases

Planned Time to Trials

< 6 Months

Additional Resources

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.

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