Vir Biotechnology Awarded BARDA Funding to Support Development of Antibody Platform Technologies for Global Infectious Disease Threats
03 10월 2023 - 8:59PM
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the
Biomedical Advanced Research and Development Authority (BARDA),
part of the U.S. Department of Health and Human Services’ (HHS)
Administration for Strategic Preparedness and Response (ASPR), has
awarded Vir approximately $50 million in new funding to advance the
development of novel monoclonal antibody (mAb) candidates and
delivery solutions to widen the applicability of mAbs in COVID-19
and in pandemic preparedness and response.
“We are honored to continue to collaborate with
the U.S. government as we leverage our world-class antibody
platform with the hope of generating powerful new medicines to
protect our communities from global infectious disease threats,
including pathogens with pandemic potential,” said Marianne De
Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. “We are
grateful to the U.S. government for its continued support of our
innovative technological approaches in mAb research and development
as we seek to optimize mAb delivery. We look forward to starting
this with VIR-7229, a next-generation COVID-19 mAb that has been
shown in preclinical studies to have high potency against
historical and currently circulating variants, and that has the
potential to be the best in class.”
The new funding will support research and
development of novel alternative mAb delivery technologies that
have the potential to revolutionize mAb delivery by increasing
expression relative to existing technologies. Such delivery could
widen the breadth of administration options and shorten development
and manufacturing timelines.
$40 million of the total funds is part of
‘Project NextGen,’ an initiative by the HHS to advance a pipeline
of new, innovative vaccines and therapeutics for COVID-19 and will
support the development of VIR-7229 through Phase 1 in the context
of developing alternative mAb delivery technologies. The Phase 1
trial is expected to be completed in the second half of 2025. $10
million of the total funds falls under support from the Division of
Chemical, Biological, Radiological and Nuclear (CBRN) medical
countermeasures of BARDA which will support the discovery of new
mAbs against a second pathogen of pandemic potential in the context
of further advancing alternative mAb delivery technologies.
The new investment falls under Vir’s existing
Other Transaction Authority (OTA), a multi-year contract BARDA
awarded Vir in 2022. This OTA allows for a potential total
investment of up to $1 billion to support Vir’s development of
future pandemic influenza mAbs as well as the potential development
of up to 10 emerging infectious disease or CBRN medical
countermeasure candidates. The balance of the potential funding is
subject to BARDA exercising up to 12 options in further support of
the development of pre-exposure prophylactic antibodies for the
prevention of influenza illness or supporting medical
countermeasures for other pathogens of pandemic potential.
Vir is also receiving approximately $11 million
in additional BARDA funding that will be applied to wind down
activities for the BARDA-supported Phase 2 PENINSULA trial
evaluating the investigational prophylactic mAb VIR-2482 for the
prevention of symptomatic influenza A illness.
These programs have been funded in whole or in
part with federal funds from the Department of Health and Human
Services; Administration for Strategic Preparedness and Response
(ASPR); Biomedical Advanced Research and Development Authority
(BARDA), under OT number: 75A50122C00081.
About VIR-7229VIR-7229 is a
potent preclinical monoclonal antibody that has shown the ability
to broadly neutralize COVID-19 variants in vitro. VIR-7229 is
designed as a prophylactic for COVID-19 and was identified using
Vir’s proprietary mAb discovery platform. VIR-7229 incorporates
Xencor, Inc.’s Xtend™️ technology and is affinity matured using
machine learning to increase its effectiveness in binding to
SARS-CoV and SARS-CoV-2 variants.
About VIR-2482VIR-2482 is an
investigational hemagglutinin targeting, intramuscularly
administered influenza A-neutralizing monoclonal antibody. In
vitro, it has been shown to cover all major strains of influenza A
that have arisen since the 1918 flu pandemic. VIR-2482 is designed
as a prophylactic for influenza A. VIR-2482 incorporates Xencor’s
Xtend™ and was identified using Vir’s proprietary mAb discovery
platform.
About Vir BiotechnologyVir
Biotechnology, Inc. is an immunology company focused on combining
cutting-edge technologies to treat and prevent infectious diseases
and other serious conditions. Vir has assembled two technology
platforms that are designed to stimulate and enhance the immune
system by exploiting critical observations of natural immune
processes. Its current clinical development pipeline consists of
product candidates targeting hepatitis B and hepatitis delta
viruses, influenza A and B, human immunodeficiency virus and
COVID-19. Vir has several preclinical candidates in its pipeline,
including those targeting RSV/MPV and HPV. Vir routinely posts
information that may be important to investors on its website.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,”
“anticipate,” “promising” and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These forward-looking statements are based on Vir’s expectations
and assumptions as of the date of this press release.
Forward-looking statements contained in this press release include,
but are not limited to, statements regarding Vir’s strategy and
plans; the potential benefits of VIR-7229 to protect against
historical and currently circulating COVID-19 variants and the
potential benefits of alternative mAb delivery technologies in
pandemic preparedness and response; wind down activities of
VIR-2482 for the prevention of symptomatic influenza A illness; the
potential benefits, safety, and efficacy of Vir’s investigational
therapies; and risks and uncertainties associated with drug
development and commercialization Many important factors may cause
differences between current expectations and actual results,
including uncertainty as to whether the anticipated benefits of the
BARDA collaboration can be achieved; unexpected safety or efficacy
data or results observed during clinical trials or in data
readouts; the timing and outcome of Vir’s planned interactions with
regulatory authorities; difficulties in obtaining regulatory
approval; uncertainty as to whether the anticipated benefits of
Vir’s collaborations with other companies can be achieved;
difficulties in collaborating with other companies; challenges in
accessing manufacturing capacity; clinical site activation rates or
clinical trial enrollment rates that are lower than expected;
successful development and/or commercialization of alternative
product candidates by Vir’s competitors; changes in expected or
existing competition; delays in or disruptions to Vir’s business or
clinical trials, geopolitical changes or other external factors;
and unexpected litigation or other disputes. Drug development and
commercialization involve a high degree of risk, and only a small
number of research and development programs result in
commercialization of a product. Results in early-stage clinical
trials may not be indicative of full results or results from
later-stage or larger-scale clinical trials and do not ensure
regulatory approval. You should not place undue reliance on these
statements or the scientific data presented. Other factors that may
cause actual results to differ from those expressed or implied in
the forward-looking statements in this press release are discussed
in Vir’s filings with the US Securities and Exchange Commission,
including the section titled “Risk Factors” contained therein.
Except as required by law, Vir assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
Contacts:
Media
Carly Scaduto
Senior Director, Media Relations
cscaduto@vir.bio
+1-314-368-5189
Investors
Sasha Damouni Ellis
Executive Vice President, Chief Corporate Affairs Officer
sdamouni@vir.bio
Vir Biotechnology (NASDAQ:VIR)
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