- Bebtelovimab (LY-CoV1404) neutralizes Omicron, including the
subvariant BA.2, as demonstrated by pseudovirus and/or authentic
virus data
- Previously reported data show that bebtelovimab has broad and
potent neutralization of all other known circulating SARS-CoV-2
variants of concern
- Bebtelovimab binds to a rarely mutated region of the SARS-CoV-2
spike protein, suggesting the potential to retain effectiveness
against emerging variants
AbCellera (Nasdaq: ABCL) today announced that bebtelovimab
(LY-CoV1404), the second antibody developed through AbCellera’s
collaboration with Eli Lilly and Company (Lilly), has received
Emergency Use Authorization (EUA) from the U.S. Food and Drug
Administration (FDA). Bebtelovimab is authorized for the treatment
of mild-to-moderate COVID-19 in adults and pediatric patients (12
years of age and older weighing at least 40 kg) with positive
results of direct SARS-CoV-2 viral testing, and who are at high
risk for progression to severe COVID-19, including hospitalization
or death, and for whom alternative COVID-19 treatment options
approved or authorized by FDA are not accessible or clinically
appropriate. The authorized dosage of bebtelovimab is 175 mg given
as an intravenous injection over at least 30 seconds.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20220211005524/en/
Models of bebtelovimab Fabs bound to
SARS-CoV-2 spike protein mapped with key mutations from the Omicron
variant of concern. Top: Side view of a model of bebtelovimab Fabs
(target-binding fragments of the antibody, green) bound to
SARS-CoV-2 spike protein (purple) mapped with key mutations from
the Omicron variant of concern (red). Bottom: Top views of a model
of bebtelovimab Fabs (target-binding fragments of the antibody,
green) bound to SARS-CoV-2 spike protein (purple) mapped with key
mutations of the Omicron variant of concern (red). Source:
AbCellera
“At the start of the COVID-19 pandemic we and our partners
prioritized speed in getting therapies out to patients. This
resulted in the discovery of bamlanivimab, the first COVID-19
antibody to reach the clinic and receive FDA Emergency Use
Authorization,” said Carl Hansen, Ph.D., CEO of AbCellera. “We then
shifted our efforts to discovering a next-generation antibody
therapeutic, this time prioritizing maximum potency and breadth of
neutralization. This resulted in the discovery of bebtelovimab,
which neutralizes all known variants of concern, and is the most
potent antibody in development against the Omicron variant,
including BA.2. The discovery of two authorized therapeutic
antibodies within a year of each other demonstrates the power of
our platform, and its potential to quickly generate best-in-class
therapeutics for our partners.”
As previously announced, Lilly entered into a purchase agreement
with the U.S. government to supply up to 600,000 doses of
bebtelovimab no later than March 31, 2022, with an option of
500,000 additional doses no later than July 31, 2022.
Pseudovirus and authentic virus testing confirm bebtelovimab
neutralizes Omicron – currently the predominant variant in the U.S.
In addition, pseudovirus testing with bebtelovimab demonstrates
that it retains neutralization against all other known variants of
interest and concern, including BA.2. Previously reported data show
bebtelovimab is highly potent and binds to a rarely mutated region
of the SARS-CoV-2 spike protein (Westendorf et al, biorxiv, updated
January 7, 2022). Further details about the data supporting this
EUA and bebtelovimab authorized use and safety information are
available here.
About AbCellera’s Response to COVID-19
AbCellera initially mobilized its pandemic response platform
against COVID-19 in February 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
U.S. FDA. Bamlanivimab alone and together with other antibodies has
treated at least 700,000 patients, preventing COVID-19-related
hospitalizations and death.
AbCellera’s second monoclonal antibody therapy for COVID-19,
bebtelovimab, was developed to combat emerging variants.
Pseudovirus and authentic virus testing confirmed bebtelovimab
maintains binding and neutralizing activity across currently known
and reported variants of concern. It is being studied for the
treatment of mild to moderate COVID-19 both as a monotherapy and
together with other antibodies.
AbCellera’s 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.
Bamlanivimab and bebtelovimab were developed from antibodies
that were discovered using AbCellera’s pandemic response platform,
in partnership with the Vaccine Research Center (VRC) at the
National Institutes for Allergy and Infectious Diseases (NIAID).
AbCellera’s partner, Lilly, is responsible for development,
manufacturing and distribution of bamlanivimab and
bebtelovimab.
AbCellera’s pandemic response capabilities were developed over
the past four 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 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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version on businesswire.com: https://www.businesswire.com/news/home/20220211005524/en/
Inquiries Media: Jessica Yingling, Ph.D.;
media@abcellera.com, +1(236)521-6774 Business Development:
Neil Berkley; bd@abcellera.com, +1(604)559-9005 Investor
Relations: Melanie Solomon; ir@abcellera.com,
+1(778)729-9116
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