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

Rhea-AI Summary

AbCellera (Nasdaq: ABCL) announced an expanded Emergency Use Authorization (EUA) from the FDA for the combination of bamlanivimab and etesevimab for pediatric patients under 12, including neonates. The EUA permits treatment for mild to moderate COVID-19 and post-exposure prophylaxis. Data from the BLAZE-1 Phase 2/3 clinical trial indicated a median symptom resolution of 7 days. The treatment shows efficacy against the Delta variant, currently prevalent in the U.S.

Positive

• Expanded EUA allows treatment for a vulnerable pediatric population, potentially increasing market reach.
• Clinical trial data shows 7 days median symptom resolution, indicating effectiveness.
• Treatment retains neutralization activity against the Delta variant, ensuring relevance during ongoing pandemic.

Negative

• None.

Expanded EUA includes both treatment of patients with COVID-19 and post-exposure prophylaxis (PEP) in pediatric and infant patients

VANCOUVER, British Columbia--(BUSINESS WIRE)-- 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.

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 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 the National Institutes for 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 both the first therapeutic candidate specifically developed against SARS-CoV-2 to enter human clinical trials in North America, and to receive EUA from the FDA. Bamlanivimab alone and/or administered with etesevimab are authorized under special use pathways in more than 22 countries. In the U.S., 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.

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, please 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211203005567/en/

Inquiries



Media: Jessica Yingling, Ph.D.; media@abcellera.com, +1(236)521-6774

Business Development: Neil Berkley; bd@abcellera.com, +1(604)559-9005

Investor Relations: Melanie Solomon; ir@abcellera.com, +1(778)729-9116

Source: AbCellera Biologics Inc.

FAQ

What is the new EUA announced by AbCellera for bamlanivimab and etesevimab?

The new EUA allows bamlanivimab and etesevimab to be used together for treating pediatric patients under 12 and for post-exposure prophylaxis.

What does the BLAZE-1 trial data show for bamlanivimab?

The BLAZE-1 trial data indicates a median time to complete symptom resolution of 7 days for subjects treated with the antibody combination.

How does bamlanivimab and etesevimab perform against the Delta variant?

Studies show that bamlanivimab and etesevimab retain neutralization activity against the Delta variant, the predominant variant in the U.S.

When was the EUA expanded for bamlanivimab and etesevimab?

The expanded EUA was announced by AbCellera on December 3, 2021.

What age group is covered under the expanded EUA for bamlanivimab?

The expanded EUA covers pediatric patients under the age of 12, including neonates.