Bamlanivimab

Bamlanivimab (LY-CoV555, also known as LY3819253), is a synthetic monoclonal antibody (mAb) derived from one of the first blood samples in the United States from a patient who recovered from COVID-19. Bamlanivimab is a neutralizing IgG1κ mAb directed against the SARS-CoV-2 spike (S) protein, which is described to block viral entry into human cells.

AbCellera initially discovered bamlanivimab in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), and subsequently further developed it in collaboration with Eli Lilly and Company. Bamlanivimab consists of two identical light chains of 214 amino acids and two identical heavy chains of 455 amino acids each; the Fc region is unmodified. Bamlanivimab is produced in Chinese Hamster Ovary (CHO) cells. Based on phase 2 clinical trial (BLAZE-1) interim results, bamlanivimab was granted Emergency Use Authorization (EUA) by the FDA on November 10, 2020. It is set to enter phase 3 clinical trials.

Under the EUA granted in February 2021, bamlanivimab is used in combination with etesevimab to treat mild to moderate COVID-19 in adults and pediatric patients who are at high risk for progressing to severe COVID-19: this EUA later expanded in December 2021 to include all younger children at high risk, including newborns. The EUA currently allows bamlanivimab and etesevimab for post-exposure prophylaxis of COVID-19 in adults and children.

Bamlanivimab is not currently approved for any indication by the FDA.

Bamlanivimab is authorized under an Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 in patients aged 12 years and older weighing at least 40 kg who are at high risk for progressing to severe COVID-19 and/or hospitalization due to COVID-19. Patients should have confirmed COVID-19, with identification of SARS-CoV-2 viral load by an approved test.

Under this EUA, bamlanivimab is not authorized in patients who are hospitalized due to COVID-19, who require oxygen due to COVID-19, or in patients on oxygen therapy for non-COVID-19-related comorbidity who require an increased oxygen flow rate due to COVID-19.

Bamlanivimab in combination with etesevimab is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. This combination regimen is also used for post-exposure prophylaxis of COVID-19 in unvaccinated or immunocompromised adults and pediatric individuals, including neonates, who are at high risk of progression to severe COVID-19, including hospitalization or death.