- Bamlanivimab and etesevimab administered together neutralize
the Delta variant, which is currently the cause of over 95 percent
of new COVID-19 infections in the EU/EEA
- Participating EU/EEA countries can purchase bamlanivimab
together with etesevimab directly from Lilly following national
approval for emergency use or marketing authorization at the EU
level
AbCellera (Nasdaq: ABCL) today announced the European Commission
(EC) and Eli Lilly and Company (Lilly) have entered into a Joint
Procurement Agreement to supply up to 220,000 doses of bamlanivimab
together with etesevimab to treat confirmed COVID-19 in patients
aged 12 years and older that do not require supplemental oxygen for
COVID-19 and who are at increased risk of progressing to severe
COVID-19. The agreement helps to provide access to treatments by
enabling participating countries in the European Union (EU) and
European Economic Area (EEA) to purchase the products directly from
Lilly following national approval for emergency use or marketing
authorization at the EU level.
“It is important that we use every tool available to combat
COVID-19. With the rise of the highly contagious Delta variant, it
is critical that patients who need it have access to antibody
therapies that can neutralize the virus and prevent the progression
to severe illness,” said Carl Hansen, Ph.D., CEO and President of
AbCellera.
In the U.S., bamlanivimab alone and together with etesevimab
have been used to treat more than 535,000 patients, potentially
keeping more than 25,000 patients out of the hospital and saving
more than 10,000 lives. The Emergency Use Authorization (EUA) for
bamlanivimab together with etesevimab in the U.S. was recently
expanded to include post-exposure prophylaxis to prevent
COVID-19.
Pseudovirus and authentic virus studies demonstrate that
bamlanivimab and etesevimab together retain neutralization activity
against variants currently in circulation in many countries,
including Delta and Alpha. Based on the high transmissibility of
the Delta variant, currently over 95 percent of new COVID-19
infections in the EU/EEA have been identified as being caused by
the Delta variant.
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
U.S. Food and Drug Administration (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
the National Institutes for 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 both
the first therapeutic candidate specifically developed against
SARS-CoV-2 to enter human clinical trials in North America, and to
receive Emergency Use Authorization (EUA) from the FDA.
Bamlanivimab alone and/or administered with etesevimab are
authorized under special use pathways in more than 22 countries. 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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version on businesswire.com: https://www.businesswire.com/news/home/20210921006004/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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