AbCellera-Discovered Antibody, Bamlanivimab, Administered with Etesevimab Receives FDA Emergency Use Authorization for COVID-19
February 09 2021 - 7:26PM
Business Wire
Bamlanivimab now authorized in two antibody
therapy regimens to treat COVID-19 in patients at high risk for
hospitalization
FDA authorizes new protocols for infusion of
bamlanivimab in as few as 16 minutes
AbCellera (Nasdaq: ABCL) today announced that
bamlanivimab (LY-CoV555) 700 mg, a human antibody discovered by
AbCellera and developed with Eli Lilly and Company (Lilly),
administered with a second Lilly antibody, etesevimab (LY-CoV016)
1400 mg, has received Emergency Use Authorization (EUA) from the
U.S. Food and Drug Administration (FDA) 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. New
protocols enable front-line clinicians to administer bamlanivimab
alone and bamlanivimab and etesevimab together in as few as 16
minutes and 21 minutes, respectively.
“The data show that bamlanivimab alone and bamlanivimab and
etesevimab together are effective at reducing hospitalizations in
high-risk COVID-19 patients, with consistent and similar efficacy
across studies,” said Carl Hansen, Ph.D., CEO and President of
AbCellera. “With this EUA for bamlanivimab and etesevimab together,
there are more treatment options for patients at high risk for
hospitalization and another layer of protection against the
emergence of new viral variants.”
The EUA is based on Phase 3 data from the BLAZE-1 trial, which
were announced on January 26, 2021. In that study of more than
1,000 COVID-19 patients, those who received bamlanivimab and
etesevimab together had a reduction in hospitalizations of 70% and
none died. Lilly plans to manufacture more than 250,000 doses of
the bamlanivimab and etesevimab therapy throughout Q1 2021, and up
to a million doses by mid-2021. Details regarding the EUA and
Lilly’s plans to make COVID-19 therapies broadly available to
patients can be found 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 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 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 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.
AbCellera Forward-looking Statements
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you that forward-looking statements are based on a combination of
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forward-looking statements may not prove to be accurate. The
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Source: AbCellera Biologics Inc.
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Inquiries
Media: Jessica Yingling, Ph.D.; media@abcellera.com,
+1(236)521-6774 Business Development: Kevin Heyries, Ph.D.;
bd@abcellera.com, +1(604)559-9005 Investor Relations:
Melanie Solomon; ir@abcellera.com, +1(778)729-9116
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