− Collaboration to Evaluate RNAi Therapeutics
Targeting Three Host Factors Required for SARS-CoV-2 Infection,
Including ACE2 and TMPRSS2 −
− Vir to Lead Development of Potential
Coronavirus RNAi Therapeutic Candidates Discovered by Alnylam, with
Alnylam Retaining an Option for 50-50 Participation −
Vir Biotechnology, Inc. (Nasdaq: VIR) and Alnylam
Pharmaceuticals, Inc. (Nasdaq: ALNY) today announced an expansion
to their broad multi-target existing collaboration for the
development and commercialization of RNAi therapeutics for
infectious diseases, including SARS-CoV-2, the virus that causes
the disease COVID-19. This expansion includes up to three
additional targets focused on host factors for SARS-CoV-2,
including ACE2 and TMPRSS2, both of which are considered critical
for viral entry, with the potential for an additional host target
to emerge from Vir’s functional genomics work.
Pursuant to an amendment to the collaboration agreement, the
companies will utilize Alnylam’s recent advances in lung delivery
of novel conjugates of siRNA – the molecules that mediate RNAi –
together with Vir’s infectious disease expertise and established
capabilities, to bring forward up to three additional host
factor-targeting development candidates (DCs) to treat SARS-CoV-2
and potentially other coronaviruses as well. The two named targets
include angiotensin converting enzyme-2 (ACE2) and transmembrane
protease, serine 2 (TMPRSS2). ACE2 is known to be the viral entry
receptor for SARS-CoV-2 and other coronaviruses, while TMPRSS2 is
believed to cleave the SARS-CoV-2 spike protein to facilitate
cellular attachment. The third target is expected to emerge from
Vir’s ongoing functional genomics efforts to identify novel host
factors pertinent to coronaviral infection and targetable by siRNA,
mAbs or small molecules.
As part of the original collaboration to advance investigational
RNAi therapeutics to treat disease caused by coronavirus infection,
Alnylam has designed and synthesized over 350 siRNAs targeting
highly conserved regions of the SARS-CoV-2 genome. Lead siRNAs have
recently been identified by scientists at Alnylam and are now being
further evaluated by scientists at Vir for anti-viral activity in
support of DC selection. Upon DC selection, Vir will lead
development efforts – working closely with Alnylam to generate the
data required to enable the potential for rapid commencement of
clinical studies.
“Vir is aggressively pursuing multiple platforms and multiple
therapeutic strategies to combat the COVID-19 pandemic. We are
excited about our partnership with Alnylam – which has already led
to identification of promising siRNAs targeting SARS-CoV-2 – and
we’re pleased to now expand our efforts to evaluate the anti-viral
effects of siRNAs targeting human host factors,” said George
Scangos, Ph.D., CEO of Vir. “We share a sense of urgency with
Alnylam in advancing these efforts as quickly as possible and with
the highest priority.”
“The biopharmaceutical industry needs to advance its full
armamentarium of potential treatment approaches and strategies to
address the COVID-19 pandemic. To this end, we are excited about
the promise of targeting host factors critical for viral infection
and replication, in addition to our efforts directly targeting the
SARS-CoV-2 genome,” said John Maraganore, Ph.D., Chief Executive
Officer of Alnylam Pharmaceuticals. “At this time of enormous
public health need, we plan to act with the utmost urgency to
broaden and accelerate our efforts with Vir to develop
investigational RNAi therapeutics against COVID-19, and potentially
future coronavirus diseases.”
Under the collaboration and license agreement, as amended, in
addition to leading development of selected DCs, Vir will lead
commercialization of any products emerging from the collaboration
that gain regulatory approval. At clinical proof of concept,
Alnylam will have an option to share equally in any profits and
losses associated with the development and commercialization of
each coronavirus program. Alternatively, Alnylam may elect to earn
development and commercialization milestones and royalties on net
sales of any products resulting from the collaboration in amounts
agreed upon for each coronavirus program. These additional targets
expand the companies’ collaboration and license agreement announced
in 2017, and the subsequent amendment to that agreement announced
in March 2020, to now develop novel siRNAs for up to nine
infectious disease targets in total, including hepatitis B virus in
the Vir-2218 (ALN-HBV02) program currently in Phase 1/2
studies.
About RNAi RNAi (RNA interference) is a natural cellular
process of gene silencing that represents one of the most promising
and rapidly advancing frontiers in biology and drug development
today. Its discovery has been heralded as “a major scientific
breakthrough that happens once every decade or so,” and was
recognized with the award of the 2006 Nobel Prize for Physiology or
Medicine. By harnessing the natural biological process of RNAi
occurring in our cells, a new class of medicines, known as RNAi
therapeutics, is now a reality. Small interfering RNA (siRNA), the
molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic
platform, function upstream of today’s medicines by potently
silencing messenger RNA (mRNA) – the genetic precursors – that
encode for disease-causing proteins, thus preventing them from
being made. This is a revolutionary approach with the potential to
transform the care of patients with genetic and other diseases.
About Vir Biotechnology Vir Biotechnology is a
clinical-stage immunology company focused on combining immunologic
insights with cutting-edge technologies to treat and prevent
serious infectious diseases. Vir has assembled four technology
platforms that are designed to stimulate and enhance the immune
system by exploiting critical observations of natural immune
processes. Its current development pipeline consists of five
product candidates targeting hepatitis B virus, influenza A, human
immunodeficiency virus and tuberculosis. For more information,
please visit www.vir.bio.
About Alnylam Alnylam (Nasdaq: ALNY) is leading the
translation of RNA interference (RNAi) into a whole new class of
innovative medicines with the potential to transform the lives of
people afflicted with rare genetic, cardio-metabolic, hepatic
infectious, and central nervous system (CNS)/ocular diseases. Based
on Nobel Prize-winning science, RNAi therapeutics represent a
powerful, clinically validated approach for the treatment of a wide
range of severe and debilitating diseases. Founded in 2002, Alnylam
is delivering on a bold vision to turn scientific possibility into
reality, with a robust RNAi therapeutics platform. Alnylam’s
commercial RNAi therapeutic products are ONPATTRO® (patisiran),
approved in the U.S., EU, Canada, Japan, Switzerland, and Brazil,
and GIVLAARI® (givosiran), approved in the U.S. and EU. Alnylam has
a deep pipeline of investigational medicines, including six product
candidates that are in late-stage development. Alnylam is executing
on its "Alnylam 2020" strategy of building a multi-product,
commercial-stage biopharmaceutical company with a sustainable
pipeline of RNAi-based medicines to address the needs of patients
who have limited or inadequate treatment options. Alnylam is
headquartered in Cambridge, MA. For more information about our
people, science and pipeline, please visit www.alnylam.com and
engage with us on Twitter at @Alnylam or on LinkedIn.
Vir Forward-Looking Statements This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Words such as
“may,” “will,” “expect,” “plan,” “anticipate,” “believe,”
“estimate,” “intend,” “potential,” “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. Each of these forward-looking
statements involves risks and uncertainties. Actual results may
differ materially from these forward-looking statements.
Forward-looking statements contained in this press release include
statements regarding the potential benefits of the expansion of the
collaboration with Alnylam, whether or not any DCs will be
identified and selected, Vir’s ability to identify novel host
targets, the potential anti-viral effects of siRNAs targeting human
host factors, whether or not any DCs will be successfully developed
and commercialized, and Vir’s ability to address the COVID-19
pandemic. Many factors may cause differences between current
expectations and actual results including unexpected safety or
efficacy data observed during preclinical or clinical studies,
challenges in identifying and selecting DCs, challenges in
identifying new host factors pertinent to coronaviral infection,
difficulty in collaborating with other companies or government
agencies, and challenges in accessing manufacturing capacity and
the development of treatments for infectious diseases. 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 U.S.
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.
Alnylam Forward Looking Statements Various statements in
this release concerning Alnylam's future expectations, plans and
prospects, including, without limitation, Alnylam's views and plans
with respect to the potential for RNAi therapeutics, including the
translation to humans of recent pre-clinical progress in delivery
of siRNAs to the lung, the potential for siRNAs targeting highly
conserved regions of SARS-CoV-2 – the virus that causes COVID-19 –
and other siRNAs targeting human host factors for COVID-19 and
potentially other coronaviruses, its ability to collaborate with
Vir to address the emerging public health epidemic, and
expectations regarding the continued execution on its “Alnylam
2020” guidance for the advancement and commercialization of RNAi
therapeutics, constitute forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995. Actual results and future plans may
differ materially from those indicated by these forward-looking
statements as a result of various important risks, uncertainties
and other factors, including, without limitation: potential risks
to Alnylam’s business, activities and prospects as a result of the
COVID-19 pandemic, or delays or interruptions resulting therefrom;
Alnylam's ability to discover and develop novel drug candidates,
including candidates targeting the SARS-CoV-2 genome and/or host
factors for SARS-CoV-2 infection, and delivery approaches,
including to the lung; its ability to successfully demonstrate the
efficacy and safety of its product candidates, including candidates
targeting the SARS-CoV-2 genome and/or host factors for SARS-CoV-2
infection; the pre-clinical and clinical results for its product
candidates, which may not be replicated or continue to occur in
other subjects or in additional studies or otherwise support
further development of product candidates for a specified
indication or at all; actions or advice of regulatory agencies,
which may affect the design, initiation, timing, continuation
and/or progress of clinical trials, including the ability to
accelerate clinical trials of candidates targeting the SARS-CoV-2
genome and/or host factors for SARS-CoV-2 infection, or result in
the need for additional pre-clinical and/or clinical testing;
delays, interruptions or failures in the manufacture and supply of
its product candidates or its marketed products; obtaining,
maintaining and protecting intellectual property; intellectual
property matters including potential patent litigation relating to
its platform, products or product candidates; obtaining regulatory
approval for its product candidates, including lumasiran and any
product candidates targeting the SARS-CoV-2 genome and/or host
factors for SARS-CoV-2 infection, and maintaining regulatory
approval and obtaining pricing and reimbursement for its products,
including ONPATTRO and GIVLAARI; progress in continuing to
establish a commercial and ex-United States infrastructure;
successfully launching, marketing and selling its approved products
globally, including ONPATTRO and GIVLAARI, and achieve net product
revenues for ONPATTRO within its expected range during 2020;
Alnylam’s ability to successfully expand the indication for
ONPATTRO in the future; competition from others using technology
similar to Alnylam's and others developing products for similar
uses; Alnylam's ability to manage its growth and operating expenses
within the ranges of its expected guidance and achieve a
self-sustainable financial profile in the future, obtain additional
funding to support its business activities, and establish and
maintain strategic business alliances and new business initiatives;
Alnylam's dependence on third parties, including Vir, for
development of candidates for the treatment of infectious diseases,
including COVID-19, and commercialization of any infectious disease
product resulting therefrom; Regeneron, for development,
manufacture and distribution of certain products, including eye and
CNS products, and Ironwood, for assistance with the education about
and promotion of GIVLAARI in the U.S.; the outcome of litigation;
the risk of government investigations; and unexpected expenditures,
as well as those risks more fully discussed in the "Risk Factors"
filed with Alnylam's most recent Annual Report on Form 10-K filed
with the Securities and Exchange Commission (SEC) and in other
filings that Alnylam makes with the SEC. In addition, any
forward-looking statements represent Alnylam's views only as of
today and should not be relied upon as representing its views as of
any subsequent date. Alnylam explicitly disclaims any obligation,
except to the extent required by law, to update any forward-looking
statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200402005167/en/
Vir Biotechnology Investors: Neera Ravindran, M.D. +1 415 506 5256 nravindran@vir.bio
Media: Lindy
Devereux +1 646 515
5730 lindy@scientpr.com
Alnylam Pharmaceuticals, Inc. Christine Regan Lindenboom
(Investors and Media)
617-682-4340
Josh Brodsky
(Investors) 617-551-8276
Alnylam Pharmaceuticals (NASDAQ:ALNY)
Historical Stock Chart
From Apr 2024 to May 2024
Alnylam Pharmaceuticals (NASDAQ:ALNY)
Historical Stock Chart
From May 2023 to May 2024