– Bamlanivimab (LY-CoV555) has greater affinity and potency relative to other RBD-binding and ACE2-blocking antibodies tested in this study
– Because of its potency, bamlanivimab provides a therapeutic foundation to be administered with another antibody to expand the protection against viral variants
– Study was the first of its kind to show a neutralizing antibody can decrease SARS-CoV-2 viral shedding and transmission by blocking virus replication in the upper airway
– Bamlanivimab moved from first screen to clinical testing in 90 days1 and is the world’s first monoclonal antibody specifically developed against SARS-CoV-2 to receive FDA Emergency Use Authorization (EUA)2
– Since EUA, bamlanivimab has been used to treat approximately 400,000 high-risk COVID-19 patients in the U.S. alone and has been authorized in more than 15 countries
VANCOUVER, British Columbia–(BUSINESS WIRE)–$ABCL #COVID19–AbCellera (Nasdaq: ABCL) and collaborators today announced the publication of research in Science Translational Medicine characterizing the high potency of bamlanivimab (LY-CoV555) to neutralize SARS-CoV-2 by uniquely binding both the up and down confirmations of the spike receptor-binding domain (RBD) and inhibiting critical interactions with the angiotensin converting enzyme 2 (ACE2) cellular receptor necessary for viral entry. Data generated in a preclinical model showed prophylactic treatment with bamlanivimab resulted in significant decreases in viral load and replication in the upper and lower respiratory tracts after SARS-CoV-2 exposure, indicating the potential of bamlanivimab to reduce viral shedding and transmission. These data, which were generated prior to initiating clinical trials in June 2020 and published today, support the observed substantial clinical efficacy of bamlanivimab in treating and preventing COVID-19.
Previously Reported Clinical Trial Results
Bamlanivimab has been evaluated both alone and together with other antibodies in more than 5,000 patients across multiple clinical trials and is currently authorized in more than 15 countries. Bamlanivimab alone versus placebo has been shown to reduce hospitalization by 70% in high-risk patients with early COVID-19 infection3 and reduce the risk of contracting COVID-19 by up to 80% in nursing home residents when used as a prophylactic.4
Because of its potency, bamlanivimab also provides a therapeutic foundation to be administered with other antibodies to expand the protection against viral variants. The first of these, bamlanivimab together with etesevimab, has been authorized in the U.S. and within the European Union, and Phase 3 data show that this antibody therapy reduces COVID-19-related hospitalizations and death by 87%.5 Most importantly, across all the clinical trials, all COVID-19-related deaths occurred in patients taking the placebo; no deaths occurred in patients who received an antibody therapy, either bamlanivimab alone or together with another antibody.5
“At the beginning of our pandemic response to COVID-19, we made a decision with our partners and collaborators to develop a single antibody, emphasizing speed and scalability so that we would be able to help as many people as possible,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “Over the past four months, bamlanivimab has been used to treat hundreds of thousands of people across the world — more than any other COVID-19 antibody therapy. We believe this has kept thousands of people out of the hospital, reducing the burden on our healthcare systems, and, most importantly, has saved thousands of lives.”
Discussion of Data Published Today in Science Translational Medicine
Data from multiple in vitro assays of the 24 lead antibodies identified by AbCellera and collaborators indicated bamlanivimab displayed greater neutralization potency despite similar RBD-binding affinities, suggesting bamlanivimab has a unique binding profile to the SARS-CoV-2 spike protein. Structural analysis using X-ray crystallography and electron microscopy demonstrated that bamlanivimab binds to an area on the spike protein overlapping the ACE2 binding site that is predicted to be fully accessible in both the up and down conformations. The RBD portion of the spike protein is the primary target for virus neutralization as it mediates the conserved mechanism of viral entry to infect cells. The spike exists in an up or down position, with the up position enabling interaction with the ACE2 receptor and the down position potentially contributing to immune system evasion. Regardless of the state of the spike protein, bamlanivimab has high binding potency to the RBD of SARS-CoV-2 spike protein.
“The unique ability of bamlanivimab to bind the spike protein in both the up and down position could underlie bamlanivimab’s greater neutralization potency compared to other antibodies,” said Bo Barnhart, Ph.D., Scientific Director at AbCellera. “These preclinical data show that modest doses of bamlanivimab provided protection against SARS-CoV-2 infection, which has since been confirmed in clinical trials to protect residents and staff in long-term care facilities and nursing homes. Neutralizing antibodies, like bamlanivimab, are designed to protect our most vulnerable populations for whom vaccines are less effective. These data with bamlanivimab further confirm that neutralizing antibodies have the potential to reduce SARS-CoV-2 viral transmission and prevent infection and can provide immediate benefit when a life-saving treatment is needed.”
To determine the potential of neutralizing antibodies to prevent SARS-CoV-2 infection, nonhuman primates (NHPs) were prophylactically treated with 1, 2.5, 15, or 50 mg/kg of bamlanivimab 24 hours prior to viral challenge. Critically, viral replication as well as viral load were significantly reduced in the upper respiratory tract on Day 1 at multiple doses. Additionally, viral load and replication were significantly reduced or undetectable in the lower respiratory tract at several doses. At doses of 2.5 mg/kg and higher serum concentrations were associated with maximal protection in this model.
“The data published today give insights into why bamlanivimab is so potent and further support all of our clinical experience and data showing that bamlanivimab is a safe and effective therapy to treat and prevent COVID-19, when administered early in the course of infection,” said Ester Falconer, Ph.D., Chief Technology Officer at AbCellera and senior author of the paper. “Furthermore, bamlanivimab’s unique potency allows for lower dosing and enables administration with another antibody to address SARS-CoV-2 variants. Over the past year, we have continued to screen patient samples, identifying thousands of human antibodies and generating massive amounts of information about how the human immune system responds to COVID-19. We have tracked the variants closely and identified a next-generation antibody that is predicted to neutralize all circulating variant strains of concern of SARS-CoV-2. This antibody, currently referred to as 1404, moved into preclinical development and manufacturing in January with our partner, Eli Lilly and Company, and we are continuing to work closely with them and our collaborators for rapid advancement.”
The preclinical data for bamlanivimab was published online today in Science Translational Medicine and can be found at: https://science.sciencemag.org/lookup/doi/10.1126/science.abf1906.
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 Eli Lilly and Company (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 (LY-CoV555)
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.
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 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.
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1 AbCellera’s Rapid Pandemic Response Platform Contributes to the World’s First COVID-19 Clinical Trial for a Potential Monoclonal Antibody Treatment. June 1, 2020. https://www.abcellera.com/news/2020-06-01-worlds-first-covid-19-clinical-trial-for-a-potential-monoclonal-antibody-treatment |
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2 AbCellera-Discovered Antibody Receives U.S. FDA Emergency Use Authorization as a Monotherapy for the Treatment of COVID-19, November 9, 2020. https://www.abcellera.com/news/2020-11-09-bamlanivimab-us-fda-eua |
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3 Interim Data Reported for AbCellera-Discovered COVID-19 Antibody in Phase 2 Clinical Trials |
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https://www.abcellera.com/news/2020-09-16-interim-data-phase-2-clinical-trials |
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4 AbCellera-Discovered Antibody Prevented COVID-19 in Nursing Homes and Reduced Risks by up to 80% for Residents, January 21, 2021. https://www.abcellera.com/news/2021-01-21-abcellera-discovered-antibody-prevented-covid-19-in-nursing-homes |
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5 AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19, March 10, 2021. https://www.abcellera.com/news/2021-03-10-bamlanivimab-together-with-etesevimab-reduced-hospitalizations-and-prevented-death-in-phase-3-trial-for-early-covid-19 |
Source: AbCellera Biologics Inc.
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