- New preclinical data
show that LY-CoV1404 binds and neutralizes all currently known
circulating SARS-CoV-2 variants of concern
- LY-CoV1404 binds to
a rarely mutated region of the SARS-CoV-2 spike protein, suggesting
effectiveness against emerging variants
- LY-CoV1404
neutralizes authentic SARS-CoV-2 with high potency in vitro
- LY-CoV1404 enters
clinical trials as part of Lilly’s BLAZE-4 study in patients with
mild-to-moderate COVID-19 illness
AbCellera (Nasdaq: ABCL) today announced that a second antibody
from its collaboration with Eli Lilly and Company (Lilly),
LY-CoV1404, has entered clinical trials in patients with
mild-to-moderate COVID-19. Lilly has expanded its ongoing BLAZE-4
trials to evaluate LY-CoV1404 alone and together with other
monoclonal antibodies.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20210504005494/en/
Top: Side view of a model of LY-COV1404
Fabs (target-binding fragments of the antibody, green) bound to
SARS-CoV-2 spike protein (grey) mapped with key mutations from all
six variants of concern (red). Bottom: Top views of a model of
LY-CoV1404 Fabs (target-binding fragments of the antibody, green)
bound to SARS-CoV-2 spike protein (grey) mapped with key mutations
of each variant of concern (red). (Photo: AbCellera)
In support of this clinical study, AbCellera released
preclinical data showing LY-CoV1404 binds to a rarely mutated
region of the SARS-CoV-2 spike protein and neutralizes all
currently known variants of concern, including those first
identified in the UK (B.1.1.7), South Africa (B.1.351), Brazil
(P.1), California (B.1.426 and B.1.429), and New York (B.1.526).
LY-CoV1404 is highly potent, which could have implications for
reducing the amount of antibody necessary for clinical dosing, and
potentially enabling a subcutaneous route of administration for
either treatment or prophylaxis of COVID-19.
“When we first mobilized against COVID-19 in March of last year,
we made a decision to develop a single antibody, emphasizing speed
and scalability so that we could help as many patients as possible,
as quickly as possible. That antibody, bamlanivimab (LY-CoV555),
was the first to receive FDA Emergency Use Authorization and has
treated more patients than any other neutralizing antibody –
preventing more than 22,000 hospitalizations and 11,000 deaths in
the U.S. alone,” said Carl Hansen, Ph.D., CEO of AbCellera.
“Knowing that additional neutralizing antibodies would be needed to
combat emerging variants, we continued to screen patient samples,
and identified LY-CoV1404. Our analysis of LY-CoV1404 shows that it
is exceptionally potent and neutralizes currently known variants of
concern. We are encouraged by the potential of LY-CoV1404 to
provide a long-term complement to vaccines in the likely event that
COVID-19 becomes endemic. Our partner Lilly, who has been a leader
in rapidly developing, testing, and globally supplying COVID-19
antibody treatments, has advanced LY-CoV1404 into the clinic as
part of its ongoing BLAZE-4 trial.”
LY-CoV1404 is developed from a fully human monoclonal antibody
identified from a blood sample obtained approximately 60 days after
symptom onset from a convalescent COVID-19 patient. Preclinical
data show LY-CoV1404 potently neutralizes SARS-CoV-2 and all
current variants identified and reported to be of concern in this
pandemic. LY-CoV1404 blocks viral binding to ACE2 by targeting a
highly conserved epitope on the SARS-CoV-2 spike glycoprotein
receptor binding domain (RBD), providing a strong, well-documented
mechanism for the potent neutralizing activity. Furthermore,
LY-CoV1404 is substantially more potent in viral neutralization
assays compared to other broadly neutralizing antibodies.
“The ability of SARS-CoV-2 variants to negatively alter the
trajectory of the pandemic emphasizes the essential need for
antibody therapies that can be developed in real time to combat the
virus as it evolves,” said Bo Barnhart, Ph.D., Scientific Director
at AbCellera. “LY-CoV1404’s powerful neutralization of SARS-CoV-2
allows for exploration of lower clinical doses, which may support
subcutaneous administration and availability of more doses to treat
patients around the world.”
LY-CoV1404 uniquely binds a conserved region of the SARS-CoV-2
RBD that is distinct from other neutralizing antibodies. While the
LY-CoV1404 binding epitope includes amino acid residues N501 and
N439, LY-CoV1404 neutralizes B.1.1.7 and B.1.351, which both carry
the N501Y mutation, as potently as wild type virus in pseudovirus
assays and retains full functional neutralization against
pseudovirus with the N439K mutant. An in-depth assessment of
mutations that could inhibit neutralization of LY-CoV1404
identified two specific amino acid positions that are very rarely
mutated in the general population (0.027%), as reported in the
GISAID database as of April 2021. The potent activity of LY-CoV1404
against the currently known variants of concern and against
pseudoviruses carrying various single amino acid mutations suggests
that LY-CoV1404 binds to an epitope that is highly conserved across
all SARS-CoV-2 isolates that have been collected worldwide.
“Since the identification of bamlanivimab in our first response,
we have continued our efforts to build a panel of
well-characterized antibodies that have the potential to be
deployed rapidly to address emerging variants,” said Ester
Falconer, Ph.D., Chief Technology Officer at AbCellera. “This
strategy and the ability of our tech stack to deeply search and
efficiently analyze human immune responses to COVID-19 enabled the
discovery of LY-CoV1404. The high neutralization potency of
LY-CoV1404 to known SARS-CoV-2 variants and a variety of single
amino acid mutations that have been shown to diminish the activity
of several other neutralizing antibodies, supports the therapeutic
potential of LY-CoV1404 to address current and emerging variants
and reduce COVID-19-related illness and death.”
The preclinical data for LY-CoV1404 can be found at
https://doi.org/10.1101/2021.04.30.442182.
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. FDA. Bamlanivimab alone and together with other antibodies has
treated hundreds of thousands of patients, preventing
COVID-19-related hospitalizations and death. Bamlanivimab
alone and together with other antibodies has been authorized under
emergency/special use pathways by more than 15 countries worldwide.
In the U.S., bamlanivimab is currently only authorized for
emergency use with etesevimab.
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, LY-CoV1404, 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 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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version on businesswire.com: https://www.businesswire.com/news/home/20210504005494/en/
Media: Jessica Yingling, Ph.D.; media@abcellera.com,
+1(236)521-6774 Business Development: Kevin Heyries, Ph.D.;
bd@abcellera.com, +1(604)559-9005 Investor Relations: Melanie
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