AbCellera-Discovered Antibody Prevented COVID-19 in Nursing Homes and Reduced Risks by up to 80% for Residents
January 21 2021 - 8:27AM
Business Wire
AbCellera (Nasdaq: ABCL) today announced that bamlanivimab
(LY-CoV555), a human antibody discovered by AbCellera and developed
with Eli Lilly and Company (Lilly), significantly reduced the risk
of contracting symptomatic COVID-19 among residents and staff of
long-term care facilities. Lilly’s Phase 3 BLAZE-2 COVID-19
prevention trial was conducted in partnership 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).
Key details from the BLAZE-2 study are as follows:
- Participants were grouped based on their COVID-19 status at
baseline: 965 COVID-19 negative participants (299 residents and 666
staff) were in the prevention group, and 132 COVID-19 positive
participants (41 residents and 91 staff) were in the treatment
group;
- Participants in each group were randomized to receive either
4,200 mg of bamlanivimab or placebo;
- Serious adverse events were reported at a similar frequency in
both placebo and bamlanivimab groups, consistent with previous
safety observations in Phase 1 and Phase 2 trials;
- Bamlanivimab reduced the risk of contracting COVID-19 by up to
80% in residents versus placebo (odds ratio 0.20; p=0.00026);
and
- All deaths attributed to COVID-19 occurred in residents
receiving the placebo. There were no COVID-19-related deaths of
participants receiving bamlanivimab.
“The data from the Phase 3 BLAZE-2 trial show that bamlanivimab
provides effective protection against COVID-19 infection, with the
greatest impact on the most vulnerable patients,” said Carl Hansen,
Ph.D., CEO and President of AbCellera. “Furthermore, data obtained
from the treatment group are completely consistent with what was
observed in the BLAZE-1 trial. This reinforces the importance of
efforts to ensure high-risk patients get access to antibody therapy
early in COVID-19 infection. We believe bamlanivimab can save lives
if delivered early.”
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 for the prevention of COVID-19 in residents and staff
at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In
addition, bamlanivimab is being tested in the National Institutes
of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
Bamlanivimab 700 mg 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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