— Recent Alnylam advances in lung
delivery technology suggest possible utility of siRNAs in targeting
SARS-CoV-2 and other coronaviruses
— Vir to lead development of potential
coronavirus RNAi therapeutic candidates, with Alnylam retaining an
option for 50-50 participation
Vir Biotechnology, Inc. (Nasdaq: VIR) and Alnylam
Pharmaceuticals, Inc. (Nasdaq: ALNY) today announced an expansion
of their existing collaboration to include the development and
commercialization of RNAi therapeutics targeting SARS-CoV-2, the
virus that causes the disease COVID-19. Under the 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 one or more siRNAs to treat
SARS-CoV-2 and potentially other coronaviruses as well. The
collaboration will focus on development of siRNAs that Alnylam
recently identified that target highly conserved regions of
coronavirus RNAs.
Alnylam has designed and synthesized over 350 siRNAs targeting
all available SARS-CoV and SARS-CoV-2 genomes, which will be
screened in in vitro potency assays. Potent siRNA lead candidates
will be further evaluated by scientists at Vir for in vitro and in
vivo anti-viral activity, leading to the selection of a development
candidate (DC).
Vir will lead all development and commercialization of any
selected DCs. At clinical proof of concept, Alnylam will have an
option to share equally in the profits and losses associated with
the development and commercialization of the coronavirus program.
Alternatively, Alnylam may elect to earn development and
commercialization milestones and royalties on net sales of products
resulting from the collaboration in amounts agreed upon for the
coronavirus program. This new program expands the companies’
existing licensing agreement announced in 2017 to now develop up to
six novel siRNAs to treat infectious diseases.
“Given the scope and speed of the COVID-19 outbreak, Vir is
seeking multiple approaches that combine our expertise in
infectious disease with that of current and new partners to respond
rapidly,” said George Scangos, Ph.D., Chief Executive Officer of
Vir Biotechnology. “Alnylam has been an excellent partner, and our
complementary capabilities made this a compelling opportunity to
address this growing public health crisis.”
“RNAi is a powerful, natural cellular mechanism that can be
harnessed to develop a broad range of innovative medicines,
including anti-viral therapies. Our recent pre-clinical progress in
extra-hepatic delivery of siRNAs has now been extended to the lung,
and we’re encouraged that these results could potentially translate
to humans,” said John Maraganore, Ph.D., Chief Executive Officer of
Alnylam Pharmaceuticals. “We believe RNAi therapeutics represent a
promising approach for targeting coronaviruses, like SARS-CoV-2. As
the leader in RNAi therapeutics, we at Alnylam are committed to
doing our part in joining other biopharmaceutical companies, like
Vir, to address this emerging outbreak.”
The companies are currently collaborating on VIR-2218
(ALN-HBV02), a novel, investigational RNAi therapeutic for the
treatment of chronic hepatitis B virus (HBV) infection, the first
program to enter the clinic as a part of the infectious disease
collaboration. The safety and efficacy of VIR-2218 are currently
being investigated in an ongoing Phase 1/2 study.
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 five 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,”
“estimate,” “intend,” “potential” 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, whether or
not any DCs will be identified and selected, whether or not any DCs
will be successfully developed and commercialized, and Vir’s
ability to address the emerging public health epidemic. 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, 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 CoV RNAs,
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: Alnylam's ability to discover and develop novel drug
candidates, including candidates targeting CoV RNAs, and delivery
approaches, including to the lung, and to successfully demonstrate
the efficacy and safety of its product candidates, including
candidates targeting CoV RNAs; 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 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 CoV RNAs, 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200304005363/en/
VIR MEDIA: Lindy Devereux +1 646 515 5730 lindy@scientpr.com
VIR INVESTOR CONTACT:
Neera Ravindran, M.D.
+1 415 506 5256
nravindran@vir.bio ALNYLAM MEDIA: Christine Regan
Lindenboom +1 617 682 4340 clindeboom@alnylam.com ALNYLAM INVESTOR:
Josh Brodsky +1 617 551 8276 jbrodsky@alnylam.com
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