AbCellera-Discovered Bamlanivimab Together with Etesevimab Authorized as the First and Only Antibody Therapy for Emergency Use in COVID-19 Patients Under the Age of 12

AbCellera (Nasdaq: ABCL) today announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include pediatric patients under the age of 12, including neonates (infants <1 year old). The EUA allows for bamlanivimab and etesevimab administered together in the treatment of mild to moderate COVID-19 as well as post-exposure prophylaxis in certain patients.

The expanded EUA is based on data from the BLAZE-1 Phase 2/3 clinical trial studying bamlanivimab and etesevimab administered together for the treatment of pediatric and infant patients with mild to moderate COVID-19 and who are at high risk for severe disease progression. The median time to complete symptom resolution as recorded in a trial specific daily symptom diary was 7 days for subjects treated with bamlanivimab 700 mg and etesevimab 1,400 mg and 5 days for subjects treated with weight-based dosing of bamlanivimab and etesevimab. No subject died or required hospitalization due to COVID-19.

Pseudovirus and authentic virus studies conducted by AbCellera’s partner, Eli Lilly and Company (Lilly), demonstrate that bamlanivimab and etesevimab together retain neutralization activity against the Delta variant, which is currently the predominant variant of concern within the U.S.

For more information about the use of bamlanivimab with etesevimab for COVID-19, click here or contact Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921).

About AbCellera’s Response to COVID-19

AbCellera initially mobilized its pandemic response platform against COVID-19 in March of 2020, resulting in the discovery of bamlanivimab, the first monoclonal antibody therapy for COVID-19 to reach human testing and to be authorized for emergency use by the U.S. Food and Drug Administration (FDA). Bamlanivimab alone and together with other antibodies has treated hundreds of thousands of patients, preventing COVID-19-related hospitalizations and death.

AbCellera’s ongoing efforts to respond to the COVID-19 pandemic have identified thousands of unique anti-SARS-CoV-2 human antibodies. These include bamlanivimab, bebtelovimab, and other antibodies that are in various stages of testing by AbCellera and its partners.

AbCellera’s pandemic response capabilities were developed over the past three years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform (P3) program. The goal of the P3 program is to establish a robust technology platform for pandemic response capable of developing field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen.