AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19
AbCellera (Nasdaq: ABCL) announced positive results from a Phase 3 trial of bamlanivimab and etesevimab, reducing COVID-19-related hospitalizations and deaths by 87% in high-risk patients. No deaths occurred in the treatment group, while 14 were reported in the placebo cohort. Milestones achieved include Emergency Use Authorization from the FDA and expanded access in the EU. The study involved 769 patients, showing a safety profile consistent with earlier trials. Bamlanivimab was the first COVID-19 therapeutic candidate to receive FDA EUA.
- 87% reduction in COVID-19-related hospitalizations and deaths among treated patients.
- No COVID-19-related deaths recorded in the treatment group.
- Emergency Use Authorization granted by the FDA.
- Expanded access approved by the EMA CHMP.
- Delivery agreement for up to 1.2 million doses to the U.S. government.
- None.
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), and etesevimab 1400 mg (LY-CoV16) together reduced COVID-19-related hospitalizations and deaths by
- Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA).
- Expanded access in the European Union through the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
- Recommended use by the National Institutes of Health through its COVID-19 Treatment Guidelines.
- Delivery of up to 1.2 million doses to the U.S. government through a purchase agreement with Lilly.
“Across the two Phase 3 cohorts of the BLAZE-1 study, there were no deaths in patients who received bamlanivimab together with etesevimab, as compared to 14 deaths in patients receiving placebo, 13 of which were categorized as COVID-19-related,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “No COVID-19-related deaths have been observed across the thousands of patients who have been treated with bamlanivimab alone or together with etesevimab in clinical trials. These antibody therapies can be powerful tools in keeping COVID-19 patients out of the hospital and preventing death.”
The results from this new randomized, double-blind, placebo-controlled Phase 3 BLAZE-1 study provide additional efficacy and safety data that support the use of the dose recently granted both EUA by the U.S. FDA, and a positive scientific opinion by the EMA CHMP.
Key details from the study, which included 769 high-risk patients, aged 12 and older with mild to moderate COVID-19 (therapy: n=511; placebo: n=258), are as follows:
-
87% reduction in COVID-19-related hospitalizations and deaths versus placebo (p<0.0001). - No COVID-19-related deaths in the treatment group. All deaths occurred in patients treated with the placebo.
- A safety profile consistent with those observed from other Phase 1, Phase 2, and Phase 3 trials evaluating these antibodies.
Details regarding Lilly’s BLAZE-1 trial can be found here.
Bamlanivimab alone and together with etesevimab are authorized under special/emergency pathways, in the context of the pandemic, in the U.S. and the European Union. In addition, bamlanivimab alone is authorized for emergency use in Canada, Panama, Kuwait, the UAE, Israel, Rwanda, Morocco, and numerous other countries. Through Lilly’s work with the Bill & Melinda Gates Foundation, Lilly is providing doses of bamlanivimab free of charge in Rwanda and Morocco.
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.
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. AbCellera’s ongoing efforts to respond to the pandemic have identified more than 2,300 unique anti-SARS-CoV-2 human antibodies from multiple patient samples. These antibodies are in various stages of testing by AbCellera and its partners.
About Bamlanivimab
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) 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 emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at NIAID VRC. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
About AbCellera Biologics Inc.
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. For more information, visit www.abcellera.com.
AbCellera Forward-looking Statements
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Source: AbCellera Biologics Inc.
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