- Bamlanivimab (LY-CoV555) has greater affinity and potency
relative to other RBD-binding and ACE2-blocking antibodies tested
in this study
- Because of its potency, bamlanivimab provides a therapeutic
foundation to be administered with another antibody to expand the
protection against viral variants
- Study was the first of its kind to show a neutralizing
antibody can decrease SARS-CoV-2 viral shedding and transmission by
blocking virus replication in the upper airway
- Bamlanivimab moved from first screen to clinical testing in 90
days1 and is the world’s first monoclonal antibody specifically
developed against SARS-CoV-2 to receive FDA Emergency Use
Authorization (EUA)2
- Since EUA, bamlanivimab has been used to treat approximately
400,000 high-risk COVID-19 patients in the U.S. alone and has been
authorized in more than 15 countries
AbCellera (Nasdaq: ABCL) and collaborators today announced the
publication of research in Science Translational Medicine
characterizing the high potency of bamlanivimab (LY-CoV555) to
neutralize SARS-CoV-2 by uniquely binding both the up and down
confirmations of the spike receptor-binding domain (RBD) and
inhibiting critical interactions with the angiotensin converting
enzyme 2 (ACE2) cellular receptor necessary for viral entry. Data
generated in a preclinical model showed prophylactic treatment with
bamlanivimab resulted in significant decreases in viral load and
replication in the upper and lower respiratory tracts after
SARS-CoV-2 exposure, indicating the potential of bamlanivimab to
reduce viral shedding and transmission. These data, which were
generated prior to initiating clinical trials in June 2020 and
published today, support the observed substantial clinical efficacy
of bamlanivimab in treating and preventing COVID-19.
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the full release here:
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The unique binding of bamlanivimab to the
SARS-CoV-2 spike protein: The spike protein exists as a trimer of
three identical monomers on the surface of the SARS-CoV-2 virus.
Structural modeling (left panel) of the spike trimer in shades of
pink and white is shown with the target-binding fragments (Fabs) of
bamlanivimab (in green and yellow) bound to the RBD of the spike
protein. This analysis shows three bamlanivimab Fab fragments bound
to one spike trimer. One of the spike proteins is in the up
position (dark pink) with the other two in the down position (light
pink and white). The middle panel shows an isolated view of the
spike monomers (dark pink, white and light pink) with the bound
bamlanivimab Fab fragments in green and yellow. In the right panel,
two spike monomers bound in the up and down positions by the
bamlanivimab Fab fragments are overlaid. 3D structural model
provided by JS McLellan Group, University of Texas.
Previously Reported Clinical Trial Results
Bamlanivimab has been evaluated both alone and together with
other antibodies in more than 5,000 patients across multiple
clinical trials and is currently authorized in more than 15
countries. Bamlanivimab alone versus placebo has been shown to
reduce hospitalization by 70% in high-risk patients with early
COVID-19 infection3 and reduce the risk of contracting COVID-19 by
up to 80% in nursing home residents when used as a
prophylactic.4
Because of its potency, bamlanivimab also provides a therapeutic
foundation to be administered with other antibodies to expand the
protection against viral variants. The first of these, bamlanivimab
together with etesevimab, has been authorized in the U.S. and
within the European Union, and Phase 3 data show that this antibody
therapy reduces COVID-19-related hospitalizations and death by
87%.5 Most importantly, across all the clinical trials, all
COVID-19-related deaths occurred in patients taking the placebo; no
deaths occurred in patients who received an antibody therapy,
either bamlanivimab alone or together with another antibody.5
“At the beginning of our pandemic response to COVID-19, we made
a decision with our partners and collaborators to develop a single
antibody, emphasizing speed and scalability so that we would be
able to help as many people as possible,” said Carl Hansen, Ph.D.,
CEO and President of AbCellera. “Over the past four months,
bamlanivimab has been used to treat hundreds of thousands of people
across the world -- more than any other COVID-19 antibody therapy.
We believe this has kept thousands of people out of the hospital,
reducing the burden on our healthcare systems, and, most
importantly, has saved thousands of lives.”
Discussion of Data Published Today in Science Translational
Medicine
Data from multiple in vitro assays of the 24 lead antibodies
identified by AbCellera and collaborators indicated bamlanivimab
displayed greater neutralization potency despite similar
RBD-binding affinities, suggesting bamlanivimab has a unique
binding profile to the SARS-CoV-2 spike protein. Structural
analysis using X-ray crystallography and electron microscopy
demonstrated that bamlanivimab binds to an area on the spike
protein overlapping the ACE2 binding site that is predicted to be
fully accessible in both the up and down conformations. The RBD
portion of the spike protein is the primary target for virus
neutralization as it mediates the conserved mechanism of viral
entry to infect cells. The spike exists in an up or down position,
with the up position enabling interaction with the ACE2 receptor
and the down position potentially contributing to immune system
evasion. Regardless of the state of the spike protein, bamlanivimab
has high binding potency to the RBD of SARS-CoV-2 spike
protein.
“The unique ability of bamlanivimab to bind the spike protein in
both the up and down position could underlie bamlanivimab’s greater
neutralization potency compared to other antibodies,” said Bo
Barnhart, Ph.D., Scientific Director at AbCellera. “These
preclinical data show that modest doses of bamlanivimab provided
protection against SARS-CoV-2 infection, which has since been
confirmed in clinical trials to protect residents and staff in
long-term care facilities and nursing homes. Neutralizing
antibodies, like bamlanivimab, are designed to protect our most
vulnerable populations for whom vaccines are less effective. These
data with bamlanivimab further confirm that neutralizing antibodies
have the potential to reduce SARS-CoV-2 viral transmission and
prevent infection and can provide immediate benefit when a
life-saving treatment is needed.”
To determine the potential of neutralizing antibodies to prevent
SARS-CoV-2 infection, nonhuman primates (NHPs) were
prophylactically treated with 1, 2.5, 15, or 50 mg/kg of
bamlanivimab 24 hours prior to viral challenge. Critically, viral
replication as well as viral load were significantly reduced in the
upper respiratory tract on Day 1 at multiple doses. Additionally,
viral load and replication were significantly reduced or
undetectable in the lower respiratory tract at several doses. At
doses of 2.5 mg/kg and higher serum concentrations were associated
with maximal protection in this model.
“The data published today give insights into why bamlanivimab is
so potent and further support all of our clinical experience and
data showing that bamlanivimab is a safe and effective therapy to
treat and prevent COVID-19, when administered early in the course
of infection,” said Ester Falconer, Ph.D., Chief Technology Officer
at AbCellera and senior author of the paper. “Furthermore,
bamlanivimab’s unique potency allows for lower dosing and enables
administration with another antibody to address SARS-CoV-2
variants. Over the past year, we have continued to screen patient
samples, identifying thousands of human antibodies and generating
massive amounts of information about how the human immune system
responds to COVID-19. We have tracked the variants closely and
identified a next-generation antibody that is predicted to
neutralize all circulating variant strains of concern of
SARS-CoV-2. This antibody, currently referred to as 1404, moved
into preclinical development and manufacturing in January with our
partner, Eli Lilly and Company, and we are continuing to work
closely with them and our collaborators for rapid advancement.”
The preclinical data for bamlanivimab was published online today
in Science Translational Medicine and can be found at:
https://science.sciencemag.org/lookup/doi/10.1126/science.abf1906.
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 National Institute of 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 Eli
Lilly and Company (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 EUA from the FDA and is
currently being assessed in several clinical trials alone and
together with other antibodies.
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. 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 (LY-CoV555)
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 also
ongoing. In addition, bamlanivimab is being tested in the National
Institutes of Health-led ACTIV-2 study in ambulatory COVID-19
patients.
Bamlanivimab alone and together with etesevimab are authorized
under special/emergency pathways, in the context of the pandemic,
in the U.S. and the European Union. In addition, bamlanivimab alone
is authorized for emergency use in Canada, Panama, Kuwait, the UAE,
Israel, Rwanda, Morocco and numerous other countries. Through
Lilly’s work with the Bill & Melinda Gates Foundation, Lilly is
providing doses of bamlanivimab free of charge in Rwanda and
Morocco.
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.
__________________________
1 AbCellera’s Rapid Pandemic Response
Platform Contributes to the World’s First COVID-19 Clinical Trial
for a Potential Monoclonal Antibody Treatment. June 1, 2020.
https://www.abcellera.com/news/2020-06-01-worlds-first-covid-19-clinical-trial-for-a-potential-monoclonal-antibody-treatment
2 AbCellera-Discovered Antibody Receives
U.S. FDA Emergency Use Authorization as a Monotherapy for the
Treatment of COVID-19, November 9, 2020.
https://www.abcellera.com/news/2020-11-09-bamlanivimab-us-fda-eua
3 Interim Data Reported for
AbCellera-Discovered COVID-19 Antibody in Phase 2 Clinical
Trials
https://www.abcellera.com/news/2020-09-16-interim-data-phase-2-clinical-trials
4 AbCellera-Discovered Antibody Prevented
COVID-19 in Nursing Homes and Reduced Risks by up to 80% for
Residents, January 21, 2021.
https://www.abcellera.com/news/2021-01-21-abcellera-discovered-antibody-prevented-covid-19-in-nursing-homes
5 AbCellera-Discovered Bamlanivimab
Together with Etesevimab Reduced Hospitalizations and Prevented
Death in Phase 3 Trial for Early COVID-19, March 10, 2021.
https://www.abcellera.com/news/2021-03-10-bamlanivimab-together-with-etesevimab-reduced-hospitalizations-and-prevented-death-in-phase-3-trial-for-early-covid-19
Source: AbCellera Biologics Inc.
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Inquiries Media: Jessica Yingling, Ph.D.; media@abcellera.com,
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