AbCellera-Discovered Antibody, Bamlanivimab, Administered with Etesevimab Reduced Risk of COVID-19 Hospitalizations and Death by 70%

Rhea-AI Summary

AbCellera (Nasdaq: ABCL) has announced compelling results from the BLAZE-1 Phase 2/3 study, where bamlanivimab and etesevimab significantly reduced COVID-19-related hospitalizations and deaths by 70% compared to placebo. In a trial involving over 1,000 high-risk patients, all deaths occurred in the placebo group. Bamlanivimab was the first monoclonal antibody authorized by the FDA for COVID-19 treatment. AbCellera continues to enhance its pandemic response capabilities, having identified over 2,300 unique anti-SARS-CoV-2 antibodies.

Positive

• Bamlanivimab and etesevimab reduced COVID-19 events by 70% versus placebo (p=0.0004).
• All deaths occurred in patients receiving placebo; no deaths in treated patients.

Negative

• None.

AbCellera (Nasdaq: ABCL) today announced that bamlanivimab (LY-CoV555) 2800 mg, a human antibody discovered by AbCellera and developed with Eli Lilly and Company (Lilly), and etesevimab 2800 mg (LY-CoV16) together significantly reduced COVID-19 related hospitalizations and deaths (collectively, “events”) in more than 1,000 high-risk patients recently diagnosed with COVID-19.

Key details from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 2/3 study are as follows:

• The trial met its primary endpoint and key secondary endpoints with high statistical significance;
• Bamlanivimab and etesevimab together reduced COVID-19 events by 70% versus placebo (p=0.0004); and
• All deaths occurred in patients taking the placebo. No deaths occurred in patients taking bamlanivimab and etesevimab together.

“The data from the BLAZE-1 study are both compelling and entirely consistent with the interim data that were the basis for Emergency Use Authorization of bamlanivimab. They show that if given early in infection, antibody therapy can keep most patients out of hospitals and can save lives,” said Carl Hansen, Ph.D., CEO and President of AbCellera. "Together with the recent data reported from the BLAZE-2 trial, no COVID-19 deaths have been observed in these treatment arms in patients treated with bamlanivimab, either alone, or together with etesevimab. It is mission critical that these treatments be made available to high-risk patients as soon as possible.”

Interim data from Lilly’s Phase 2 BLAZE-1 COVID-19 trial were reported on September 16, 2020 and were the basis for authorizations of bamlanivimab 700 mg in the United States, Canada, and Europe 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.

Additional details about Lilly’s trial are available 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 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 Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and is currently being assessed in several clinical trials as both a monotherapy and in combination with other antibodies.

AbCellera’s pandemic response capabilities were developed over the past two 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 alone or bamlanivimab and etesevimab together 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.

Bamlanivimab is authorized in the U.S. for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

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

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

Source: AbCellera Biologics Inc.

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FAQ

What were the results of the BLAZE-1 study for AbCellera (ABCL)?

The BLAZE-1 study showed that bamlanivimab and etesevimab reduced COVID-19-related hospitalizations and deaths by 70% compared to placebo.

How many patients were involved in the AbCellera BLAZE-1 study?

The BLAZE-1 study involved over 1,000 high-risk patients recently diagnosed with COVID-19.

What is bamlanivimab's significance for AbCellera (ABCL)?

Bamlanivimab was the first monoclonal antibody authorized by the FDA for COVID-19 treatment.

What is the statistical significance of the BLAZE-1 study findings?

The trial met its primary and key secondary endpoints with high statistical significance (p=0.0004).

What is the future outlook for bamlanivimab and etesevimab from AbCellera?

AbCellera continues to assess bamlanivimab in several clinical trials, expanding its use as both monotherapy and in combination with other antibodies.