Emergency use authorization now includes post-exposure
prophylaxis to prevent COVID-19 in certain people who have been
exposed to someone infected with SARS-CoV-2 or who are at high risk
of exposure in an institutional setting
AbCellera (Nasdaq: ABCL) today announced the U.S. Food and Drug
Administration (FDA) has expanded the Emergency Use Authorization
(EUA) for bamlanivimab (LY-CoV555) 700 mg administered with
etesevimab (LY-CoV016) 1400 mg to include post-exposure prophylaxis
(PEP) to prevent SARS-CoV-2 infection or symptomatic COVID-19. The
neutralizing antibodies, which were authorized together by the FDA
in February 2021 to treat early COVID-19 infection, can now also be
used together to treat high-risk individuals 12 years of age and
older who have not been fully vaccinated against COVID-19 or are
not expected to mount an adequate immune response to complete
vaccination, and have been exposed to someone infected with
SARS-CoV-2 or who are at high risk of exposure in an institutional
setting, including a nursing home or prison.
“The expanded use authorization for bamlanivimab together with
etesevimab provides a way to protect the significant number of
people who, because of their situational exposure risk or medical
condition, remain vulnerable to COVID-19,” said Carl Hansen, Ph.D.,
CEO and President of AbCellera. “More than 535,000 patients have
been treated with bamlanivimab alone or together with etesevimab,
potentially keeping more than 25,000 patients out of the hospital
and saving more than 10,000 lives. With this expanded
authorization, these antibodies, which have been shown to be
effective against the highly contagious Delta variant, can now be
used to protect some of the most at-risk people exposed to the
virus.”
The expanded EUA is based on data from the Phase 3 BLAZE-2 trial
that showed bamlanivimab prevented COVID-19 in nursing homes,
reducing the risk of contracting the disease by up to 80 percent in
nursing home residents and up to 57 percent among residents and
staff of long-term care facilities. Eli Lilly and Company’s (Lilly)
study 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).
Pseudovirus and authentic virus studies demonstrate that
bamlanivimab and etesevimab together retain neutralization activity
against the Alpha and Delta variants. On September 2nd, the Office
of the Assistant Secretary for Preparedness and Response (ASPR),
alongside the FDA, resumed the shipment and distribution of
bamlanivimab and etesevimab administered together.
For information about the use of bamlanivimab and etesevimab
together for the treatment and prevention of mild to moderate
COVID-19 in high-risk patients under the FDA's emergency use
authorization, please click here or contact Lilly's 24-hour support
line at 1-855-LillyC19 (1-855-545-5921).
About AbCellera’s Response to COVID-19
AbCellera initially mobilized its pandemic response platform
against COVID-19 in March of 2020, resulting in the discovery of
bamlanivimab, the first monoclonal antibody therapy for COVID-19 to
reach human testing and to be authorized for emergency use by the
FDA. Bamlanivimab alone and together with other antibodies has
treated hundreds of thousands of patients, preventing
COVID-19-related hospitalizations and death.
AbCellera’s ongoing efforts to respond to the COVID-19 pandemic
have identified thousands of unique anti-SARS-CoV-2 human
antibodies. These include bamlanivimab, bebtelovimab, and other
antibodies that are in various stages of testing by AbCellera and
its partners.
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.
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 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 both the first
therapeutic candidate specifically developed against SARS-CoV-2 to
enter human clinical trials in North America, and to receive EUA
from the FDA. Bamlanivimab alone and/or administered with
etesevimab are authorized under special use pathways in more than
22 countries, spanning four continents. In the U.S., bamlanivimab
is currently only authorized for emergency use with etesevimab.
Results from a Phase 2/3 study in people recently diagnosed with
COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) were
published in the New England Journal of Medicine. Results from a
Phase 3 study of bamlanivimab in residents and staff at long-term
care facilities (BLAZE-2, NCT04497987) were published in the
Journal of American Medical Association. A Phase 2 study assessing
the efficacy and safety of bamlanivimab alone, and bamlanivimab
with other neutralizing antibodies versus placebo for the treatment
of symptomatic low-risk COVID-19 in the outpatient setting
(BLAZE-4, NCT04634409) has completed enrollment.
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, please 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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