Therapy Areas: AIDS & HIV
Lilly to Supply 614,000 Additional Doses of AbCellera-Discovered Bamlanivimab Together with Etesevimab to the US government for the Treatment or Post-Exposure Prevention of COVID-19
2 November 2021 - - Canada-based AbCellera (NASDAQ: ABCL) has announced an additional purchase by the US government from Eli Lilly and Company (NYSE: LLY) for bamlanivimab with etesevimab for administration together.

This neutralizing antibody therapy is authorized for emergency use for the treatment of mild to moderate COVID-19 or for post-exposure prophylaxis of COVID-19 in certain individuals.

As part of the agreement, Lilly will supply 614,000 doses of bamlanivimab with etesevimab no later than January 31, 2022.

A minimum of 400,000 doses will be supplied no later than December 31, 2021. Details regarding Lilly's agreement to provide the US government with 614,000 additional doses of bamlanivimab with etesevimab for a total of USD 1.29bn can be found here.

In the US, bamlanivimab alone and together with etesevimab has been used to treat more than 535,000 patients, potentially keeping more than 25,000 patients out of the hospital and saving more than 10,000 lives.

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 US Food and Drug Administration.

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 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.

Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2.

It is designed to block viral attachment and entry into human cells, thus neutralizing the virus. 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 at the National Institutes for Allergy and Infectious Diseases (NIAID).

Within one week of receiving the sample, AbCellera screened over five m 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 both the first therapeutic candidate specifically developed against SARS-CoV-2 to enter human clinical trials in North America, and to receive Emergency Use Authorization from the FDA.

Bamlanivimab alone and/or administered with etesevimab are authorized under special use pathways in more than 22 countries. In the US, bamlanivimab is currently only authorized for emergency use with etesevimab.

Results from a Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) were published in the New England Journal of Medicine.

Results from a Phase 3 study of bamlanivimab in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) were published in the Journal of American Medical Association.

A Phase 2 study assessing the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralizing antibodies versus placebo for the treatment of symptomatic low-risk COVID-19 in the outpatient setting (BLAZE-4, NCT04634409) has completed enrollment.

AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease.

AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.
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