EMA Advises Use of AbCellera-Discovered Bamlanivimab, Alone or Together with Etesevimab, to Treat Confirmed COVID-19 Patients
Positive European Union (EU)-level scientific opinion provides a pathway for more EU countries to access the antibodies to treat COVID-19 before formal marketing authorizations are granted
VANCOUVER, British Columbia – AbCellera (Nasdaq: ABCL) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. The opinion advises bamlanivimab alone and bamlanivimab administered together with etesevimab can be used for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19. The CHMP recommendation provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies, which can be used by EU member states when making decisions on the possible use of the therapies at a national level prior to market authorization.
“Bamlanivimab has been used to treat hundreds of thousands of patients globally, and its impact continues to grow as the use of COVID-19 antibody therapies accelerates,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “Several EU countries have authorized bamlanivimab, and the EMA’s CHMP recommendation provides a mechanism for more EU countries to quickly access these antibodies to treat patients in need.”
The EMA reviewed Phase 2 and Phase 3 results from Eli Lilly and Company’s (Lilly) BLAZE-1 trial to support the CHMP opinion. Results from BLAZE-1 demonstrated bamlanivimab alone reduced viral load and rates of symptoms and also reduced hospitalization by approximately 70%, and bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70% in non-hospitalized high-risk patients with mild to moderate COVID-19. Details regarding the CHMP opinion and Lilly’s plans to make COVID-19 therapies broadly available to patients can be found here.
Bamlanivimab has been authorized in more than 10 countries, and bamlanivimab together with etesevimab received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on February 9, 2021. The EUA was followed by a $210 million purchase agreement for Lilly to provide 100,000 doses of bamlanivimab and etesevimab to the U.S. government through to March 31, 2021. The U.S. government will have the option to purchase up to an additional 1,100,000 doses through November 25, 2021. This purchase agreement is in addition to the 1,450,000 doses of bamlanivimab alone that the US government previously committed to purchase: to date, more than 1 million doses have been delivered, and Lilly has agreed to deliver 450,000 additional doses by March 31, 2021. AbCellera is eligible to receive royalties in the low- to mid-teens for aggregate sales below $125.0 million and mid-teens to mid-twenties on aggregate sales above $125.0 million. Sales of bamlanivimab in 2020 were $871 million.
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.
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.
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