Business & Investment

Emergency Use Authorization for Bamlanivimab Found in Abcellera Administered with Etesevimab Extended by the FDA to Include Post-Exposure Prophylaxis for the Prevention of COVID-19

Article content

Emergency Use Authorization now includes post-exposure prophylaxis to prevent COVID-19 in certain people who have been exposed to SARS-CoV-2 or are at high risk of exposure in the facility. I did.

Vancouver, British Columbia — Abcellera (Nasdaq: ABCL) today the U.S. Food and Drug Administration (FDA) expands the Emergency Use Authorization (EUA) for gamlanivimab (LY-CoV555) 700 mg and etesebimab (LY-CoV016) 1400 mg to include post-exposure prophylaxis. Was announced. (PEP) To prevent SARS-CoV-2 infection or symptomatic COVID-19. Neutralizing antibodies, co-approved by the FDA in February 2021 to treat early infections with COVID-19, treat high-risk individuals aged 12 years and older who have not been fully vaccinated with COVID-19. You can now use it together to do so. Or, those who are not expected to initiate an appropriate immune response to a complete vaccination and are infected with SARS-CoV-2, or who are at high risk of exposure in institutions such as nursing homes and prisons. Was exposed to.

advertisement

Article content

“Expanding gamlanivimab and etesebimab licenses provides a way to protect a significant number of people who remain vulnerable to COVID-19 due to contextual exposure risk or medical condition,” said CEO. Dr. Carl Hansen said. President of Abcellera. “More than 535,000 patients are being treated with gamlanivimab alone or with etesebimab, which could discharge more than 25,000 patients and save more than 10,000 lives. This extended approval is contagious. These antibodies, which have been shown to be effective against high delta variants, can be used to protect the most at-risk people exposed to the virus. ”

Extended EUA data from Phase 3 BLAZE-2 trials showing that gamlanivimab prevents COVID-19 in nursing homes, reducing the risk of contracting up to 80% in nursing homes and 57% in residents It is based on. Nursing care facility staff. The Eli Lilly and Company (Lily) study was conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN).

Studies of pseudoviruses and real viruses have shown that gamlanivimab and etesebimab together retain neutralizing activity against alpha and delta mutants. On September 2, the Assistant Secretary of State for Preparation and Response (ASPR), along with the FDA, resumed shipping and distribution of gamlanivimab and etesebimab, which were co-administered.

Click here for information on the combination of gamlanivimab and etesebimab for the treatment and prevention of mild to moderate COVID-19 in high-risk patients under the FDA’s Emergency Use Authorization. here Alternatively, please contact Lilly’s 24-hour support line (1-855-LillyC19 (1-855-545-5921)).

About Abcellera’s reaction to COVID-19

Abcellera initially mobilized a pandemic-ready platform for COVID-19 in March 2020, resulting in the discovery of bumlanivimab, the first monoclonal antibody therapy for COVID-19. Bamlanivimab treated hundreds of thousands of patients alone and with other antibodies to prevent COVID-19-related hospitalizations and deaths.

advertisement

Article content

Abcellera’s ongoing efforts to address the COVID-19 pandemic have identified thousands of unique anti-SARS-CoV-2 human antibodies. These include gamlanivimab, bebutellobimab, and other antibodies that are in various stages of testing by AbCellera and its partners.

Abcellera’s pandemic response capabilities have been 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 pandemics that can develop ready-to-use medical measures in the field within 60 days of isolation of an unknown viral pathogen.

About Bamlanivimab

Bamlanivimab is a recombinant neutralized human IgG1 monoclonal antibody (mAb) against the SARS-CoV-2 peplomer. It is designed to neutralize the virus by blocking the attachment of the virus and its invasion into human cells. Bamlanivimab was developed in collaboration with NIAID’s Vaccine Research Center (VRC) from antibodies found in the blood of recovered COVID-19 patients using Abcellera’s pandemic-enabled platform. Within a week of receiving the sample, Abcellera screened over 5 million antibody-producing cells to identify and isolate approximately 500 unique antibodies that bind to SARS-CoV-2, the virus that causes COVID-19. Did. The bound antibody was then tested with Abcellera, VRC, and Lily to find the most effective antibody to neutralize the virus. Bamlanivimab was selected as a primary candidate for this antibody group and was the first treatment candidate specially developed to participate in human clinical trials against SARS-CoV-2 in North America and obtain an EUA from the FDA. .. Bamlanivimab alone and / or in combination with etesebimab is licensed under special use routes in more than 22 countries across four continents. In the United States, bumlanivimab is currently only permitted for emergency use with etesebimab.

Results of a Phase 2/3 study in people recently diagnosed with COVID-19 in an outpatient setting (BLAZE-1) NCT04427501) Was published in New England Journal of Medicine.. Results of a Phase 3 Study of Bamlanivimab in Long-Term Care Residents and Staff (BLAZE-2, NCT04497987) Was published in Journal of American Medical Association.. A phase II study evaluating the efficacy and safety of gamlanivimab alone and in combination with placebo with other neutralizing antibodies for the treatment of symptomatic low-risk COVID-19 in outpatients (BLAZE-4, BLAZE-4, NCT04634409)Registration has been completed.

advertisement

Article content

About Abcelera Biologics Co., Ltd.

Abcellera is a technology company that searches, decodes, and analyzes the natural immune system to find antibodies that allow partners to develop into drugs to prevent and treat disease. AbCellera is able to partner with drug developers of all sizes, from large pharmaceutical companies to small biotechnology companies, to act quickly, reduce costs and tackle the most difficult problems in drug development. increase. For more information, please visit: www.abcellera.com..

Description of Abcellera’s future outlook

This press release contains forward-looking statements, including statements made in accordance with the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on management’s beliefs and assumptions, as well as information currently available to management. All statements contained in this release, except historical fact statements, include the ability to develop, commercialize, and achieve market acceptance of current and planned products and services, R & D efforts, and other matters. This is a description of the future outlook, including. Our business strategy, use of capital, operating results and financial position, as well as future business plans and objectives.

In some cases, the words “may”, “do”, “can”, “do”, “should”, “expect”, “intend”, “plan”, “expect” You can identify the forward-looking statement at. “Believe”, “estimate”, “predict”, “plan”, “potential”, “continue”, “continue”, or the denial of these or other equivalent terms. However, not all forward-looking statements include these words. These statements include risks, uncertainties, and other statements that may cause actual results, levels of activity, performance, or outcomes to differ materially from the information expressed or implied by these forward-looking statements. Factors are included. These risks, uncertainties and other factors are described in “Risk Factors”, “Management’s Review and Analysis of Financial Position and Performance” and elsewhere in the documents we submit to the Securities and Exchange Commission from time to time. It has been. Please be aware that forward-looking statements are based on a combination of facts and factors that we are currently aware of and our forward-looking statements. As a result, forward-looking statements may not be accurate. The forward-looking statements in this press release represent our views as of today. We undertake no obligation to update any forward-looking statement for any reason, except as required by law.

Source: AbCellera Biologics Inc.

View the source version on businesswire.com: https://www.businesswire.com/news/home/20210916005867/en/

logo

contact address

inquiry
media: Dr. Jessica Ingling; media@abcellera.com, +1 (236) 521-6774
Business Development: Neil Berkeley; bd@abcellera.com, +1 (604) 559-9005
Investor Public Relations: Melanie Solomon; ir@abcellera.com, +1 (778) 729-9116

#distro

advertisement

comment

Postmedia maintains a lively yet civic discussion forum and encourages all readers to share their views on our articles. Moderation can take up to an hour for comments to appear on your site. Comments are relevant and should be stored with respect. You have enabled email notifications. You will now receive an email when you receive a reply to a comment, when the comment thread you are following is updated, or when a user follows a comment.Please see us Community guidelines For details and details of the adjustment method Email Configuration.

Emergency Use Authorization for Bamlanivimab Found in Abcellera Administered with Etesevimab Extended by the FDA to Include Post-Exposure Prophylaxis for the Prevention of COVID-19

https://financialpost.com/pmn/press-releases-pmn/business-wire-news-releases-pmn/emergency-use-authorization-of-abcellera-discovered-bamlanivimab-administered-with-etesevimab-expanded-by-the-fda-to-include-post-exposure-prophylaxis-for-the-prevention-of-covid-19 Emergency Use Authorization for Bamlanivimab Found in Abcellera Administered with Etesevimab Extended by the FDA to Include Post-Exposure Prophylaxis for the Prevention of COVID-19

Back to top button