AbCellera-Discovered Antibody Receives FDA EUA for COVID-19 Treatment

AbCellera's bebtelovimab, a monoclonal antibody therapy, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19. Developed in collaboration with Eli Lilly and Company, bebtelovimab is authorized for use in adults and pediatric patients 12 years of age and older weighing at least 40 kg with positive SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19.

The authorized dosage of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds. The discovery of bebtelovimab was made using AbCellera's pandemic response platform, which was developed over four years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform (P3) program.

"This is a significant milestone in our response to the COVID-19 pandemic," said Carl Hansen, CEO of AbCellera. "We prioritized speed in getting therapies out to patients at the start of the pandemic, which resulted in the first authorized therapy, bamlanivimab. We then shifted our focus to discovering a next-generation antibody therapeutic, prioritizing maximum potency and breadth of neutralization. Bebtelovimab is the outcome of this effort, and we are proud to see it receive EUA."

Key Takeaways:

AbCellera's bebtelovimab has received Emergency Use Authorization (EUA) from the FDA for the treatment of mild-to-moderate COVID-19.
Developed in collaboration with Eli Lilly and Company, bebtelovimab is authorized for use in adults and pediatric patients 12 years of age and older, weighing at least 40 kg.
The authorized dosage of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds.
AbCellera's pandemic response platform was developed over four years as part of the DARPA Pandemic Prevention Platform (P3) program.
Bebtelovimab neutralizes all known variants of concern, including Omicron, and is the most potent antibody in development against Omicron.
AbCellera has collaborated with Lilly to supply up to 1,100,000 doses of bebtelovimab, with an option for an additional 500,000 doses.

Statistics:

Up to 1,100,000 doses of bebtelovimab are available under the partnership with Lilly.
Bebtelovimab has been shown to neutralize all known variants of concern, including Omicron.
AbCellera's pandemic response platform has identified thousands of unique anti-SARS-CoV-2 human antibodies.
Bamlanivimab and bebtelovimab were developed from antibodies discovered using AbCellera's pandemic response platform.

Sources:

"AbCellera-Discovered Antibody, Bebtelovimab, Receives U.S. FDA Emergency Use Authorization for the Treatment of Mild-to-Moderate COVID-19" (February 11, 2022)
"AbCellera Initials Pandemic Response to COVID-19" (2020)
DARPA Pandemic Prevention Platform (P3) program