AbCellera-Discovered Antibody, Bamlanivimab, Administered with Etesevimab Reduced Risk of COVID-19 Hospitalizations & Death b...
January 26 2021 - 7:09AM
Business Wire
AbCellera (Nasdaq: ABCL) today announced that bamlanivimab
(LY-CoV555) 2800 mg, a human antibody discovered by AbCellera and
developed with Eli Lilly and Company (Lilly), and etesevimab 2800
mg (LY-CoV16) together significantly reduced COVID-19 related
hospitalizations and deaths (collectively, “events”) in more than
1,000 high-risk patients recently diagnosed with COVID-19.
Key details from the randomized, double-blind,
placebo-controlled BLAZE-1 Phase 2/3 study are as follows:
- The trial met its primary endpoint and key secondary endpoints
with high statistical significance;
- Bamlanivimab and etesevimab together reduced COVID-19 events by
70% versus placebo (p=0.0004); and
- All deaths occurred in patients taking the placebo. No deaths
occurred in patients taking bamlanivimab and etesevimab
together.
“The data from the BLAZE-1 study are both compelling and
entirely consistent with the interim data that were the basis for
Emergency Use Authorization of bamlanivimab. They show that if
given early in infection, antibody therapy can keep most patients
out of hospitals and can save lives,” said Carl Hansen, Ph.D., CEO
and President of AbCellera. "Together with the recent data reported
from the BLAZE-2 trial, no COVID-19 deaths have been observed in
these treatment arms in patients treated with bamlanivimab, either
alone, or together with etesevimab. It is mission critical that
these treatments be made available to high-risk patients as soon as
possible.”
Interim data from Lilly’s Phase 2 BLAZE-1 COVID-19 trial were
reported on September 16, 2020 and were the basis for
authorizations of bamlanivimab 700 mg in the United States, Canada,
and Europe 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.
Additional details about Lilly’s trial are available
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 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 Emergency Use Authorization (EUA) from the U.S. Food and
Drug Administration (FDA) and is currently being assessed in
several clinical trials as both a monotherapy and in combination
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 alone or bamlanivimab and etesevimab together 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 is authorized in the U.S. for the treatment of mild
to moderate COVID-19 in adults and pediatric patients 12 years and
older with a positive COVID-19 test, who are at high risk for
progressing to severe COVID-19 and/or hospitalization. Bamlanivimab
should be administered as soon as possible after a positive
COVID-19 test and within 10 days of symptom onset.
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.
Source: AbCellera Biologics Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210126005601/en/
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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