AbCellera-Discovered Antibody, Bamlanivimab, Administered with Etesevimab Receives FDA Emergency Use Authorization for COVID-19

AbCellera (Nasdaq: ABCL) today announced that bamlanivimab (LY-CoV555) 700 mg, a human antibody discovered by AbCellera and developed with Eli Lilly and Company (Lilly), administered with a second Lilly antibody, etesevimab (LY-CoV016) 1400 mg, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. New protocols enable front-line clinicians to administer bamlanivimab alone and bamlanivimab and etesevimab together in as few as 16 minutes and 21 minutes, respectively.

“The data show that bamlanivimab alone and bamlanivimab and etesevimab together are effective at reducing hospitalizations in high-risk COVID-19 patients, with consistent and similar efficacy across studies,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “With this EUA for bamlanivimab and etesevimab together, there are more treatment options for patients at high risk for hospitalization and another layer of protection against the emergence of new viral variants.”

The EUA is based on Phase 3 data from the BLAZE-1 trial, which were announced on January 26, 2021. In that study of more than 1,000 COVID-19 patients, those who received bamlanivimab and etesevimab together had a reduction in hospitalizations of 70% and none died. Lilly plans to manufacture more than 250,000 doses of the bamlanivimab and etesevimab therapy throughout Q1 2021, and up to a million doses by mid-2021. Details regarding the EUA and Lilly’s plans to make COVID-19 therapies broadly available to patients can be found here.

About AbCellera’s Response to COVID-19

Bamlanivimab was developed from an antibody that was discovered from the blood of a recovered COVID-19 patient using AbCellera’s pandemic response platform, in partnership with the Vaccine Research Center (VRC) at National Institute of Allergy and Infectious Diseases (NIAID). Within one week of receiving the sample, AbCellera screened over five million antibody-producing cells to identify and isolate approximately 500 unique antibodies that bind to SARS-CoV-2, the virus that causes COVID-19. The binding antibodies were then tested by AbCellera, the VRC, and Lilly to find those most effective in neutralizing the virus. Bamlanivimab was selected as the lead candidate from this group of antibodies, and was the first therapeutic candidate specifically developed against SARS-CoV-2 to enter human clinical trials in North America. Bamlanivimab was the first monoclonal antibody to receive EUA from the FDA and is currently being assessed in several clinical trials alone and together with other antibodies.