Biogen Inc. (Nasdaq: BIIB) and Denali Therapeutics Inc.
(Nasdaq: DNLI) today announced that Biogen has exercised the option
to license Denali’s Antibody Transport Vehicle (ATV):Amyloid beta
program (ATV:Aβ). Accumulation of Aβ plaque in the brain is a
defining feature of Alzheimer’s disease (AD). Using Denali’s ATV
platform to cross the blood-brain barrier (BBB), ATV:Aβ is designed
to increase brain exposure and target engagement of antibody
therapeutics directed against Aβ, which may enable improved plaque
clearance and/or reduced amyloid-related imaging abnormalities
(ARIA).
“Recent progress with Aβ-directed therapeutic antibodies enables
new treatment options for people living with AD, and clinical trial
data have demonstrated that clearance of aggregated Aβ is
associated with benefit for patients,” said Joseph Lewcock, Ph.D.,
Chief Scientific Officer of Denali. “Our ATV:Aβ program is designed
to safely increase exposure of the therapeutic antibody in the
brain and potentially lead to improved efficacy and/or safety. We
are pleased with Biogen’s decision to license ATV:Aβ and we are
hopeful this will foster the development of next-generation anti-Aβ
therapeutics.”
“This decision is an important next step of our collaboration
with Denali on ATV:Aβ that aims to advance the next generation of
Aβ immunotherapies for the treatment of Alzheimer’s disease,” said
Dominic Walsh, Head of the Neurodegenerative Research Unit at
Biogen. “This program reinforces the importance of targeting Aβ and
our commitment to Alzheimer’s disease.”
The option was exercised pursuant to a collaboration between
Biogen and Denali announced in 2020. Following the exercise of the
option, Biogen will assume responsibility for all development and
commercial activities and associated expenses. Denali will receive
a one-time option exercise payment and, should certain milestones
be achieved, Denali will be eligible to receive potential
development and commercial milestone payments and royalties based
on future net sales.
About Denali’s Transport Vehicle PlatformThe
BBB is essential in maintaining the brain’s microenvironment and
protecting it from harmful substances and pathogens circulating in
the bloodstream. Historically, the BBB has posed significant
challenges to drug development for central nervous system diseases
by preventing most drugs from reaching the brain in therapeutically
relevant concentrations. Denali’s Transport Vehicle platform is a
proprietary technology designed to effectively deliver large
therapeutic molecules such as antibodies, enzymes, proteins, and
oligonucleotides across the BBB after intravenous administration.
The Transport Vehicle technology is based on engineered Fc domains
that bind to specific natural transport receptors, such as
transferrin receptors, which are expressed at the BBB and deliver
the Transport Vehicle and its therapeutic cargo to the brain
through receptor-mediated transcytosis. In animal models,
antibodies and enzymes engineered with the Transport Vehicle
technology demonstrate more than 10- to 30-fold greater brain
exposure than similar antibodies and enzymes without this
technology. Improved exposure and broad distribution in the brain
may increase therapeutic efficacy by enabling widespread
achievement of therapeutically relevant concentrations of product
candidates.
About BiogenFounded in 1978, Biogen is a
leading global biotechnology company that has pioneered multiple
breakthrough innovations including a broad portfolio of medicines
to treat multiple sclerosis, the first approved treatment for
spinal muscular atrophy, and two co-developed treatments to address
a defining pathology of Alzheimer’s disease. Biogen is advancing a
pipeline of potential novel therapies across neurology,
neuropsychiatry, specialized immunology and rare diseases and
remains acutely focused on its purpose of serving humanity through
science while advancing a healthier, more sustainable and equitable
world.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social
media - Twitter, LinkedIn, Facebook, YouTube.
About Denali TherapeuticsDenali Therapeutics is
a biopharmaceutical company developing a broad portfolio of product
candidates engineered to cross the blood-brain barrier (BBB) for
the treatment of neurodegenerative and lysosomal storage diseases.
Denali pursues new treatments by rigorously assessing genetically
validated targets, engineering delivery across the BBB and guiding
development through biomarkers that demonstrate target and pathway
engagement. Denali is based in South San Francisco. For additional
information, please visit www.denalitherapeutics.com.
Biogen Safe Harbor This press release
contains forward-looking statements, made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995, including the potential benefits of Denali’s TV technology
platform and TV programs including its ATV: anti-amyloid beta
program; the treatment of Alzheimer’s disease; the potential of
Biogen’s commercial business and pipeline programs; Biogen’s
strategy and plans; the potential treatment of neurological and
neurodegenerative diseases; and risks and uncertainties associated
with drug development and commercialization. These forward-looking
statements may be accompanied by words such as “aim,” “anticipate,”
“believe,” “could,” “estimate,” “expect,” “forecast,” “goal,”
“intend,” “may,” “plan,” “potential,” “possible,” “will,” “would”
and other words and terms of similar meaning. 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.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including, without limitation: risks that the
proposed transaction will be completed in a timely manner or at
all; the possibility that certain closing conditions to the
proposed transaction will not be satisfied; uncertainty as to
whether the anticipated benefits of the proposed collaboration can
be achieved; risks of unexpected hurdles, costs or delays;
uncertainty of success in the development and potential
commercialization of Denali’s TV technology platform and TV
programs including its ATV: anti-amyloid beta program, which may be
impacted by, among other things, unexpected concerns that may arise
from additional data or analysis, the occurrence of adverse safety
events, failure to obtain regulatory approvals in certain
jurisdictions, failure to protect and enforce Biogen’s data,
intellectual property and other proprietary rights and
uncertainties relating to intellectual property claims and
challenges; product liability claims; third party collaboration
risks; and the direct and indirect impacts of the ongoing COVID-19
pandemic on Biogen’s business, results of operations and financial
condition. The foregoing sets forth many, but not all, of the
factors that could cause actual results to differ from Biogen’s
expectations in any forward-looking statement. Investors should
consider this cautionary statement, as well as the risks factors
identified in Biogen’s most recent annual or quarterly report and
in other reports Biogen has filed with the U.S. Securities and
Exchange Commission. These statements speak only as of the date of
this press release. Biogen does not undertake any obligation to
publicly update any forward-looking statements, whether as a result
of new information, future developments or otherwise.
Denali Safe HarborThis press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements expressed or implied in this press release include, but
are not limited to, statements regarding plans, timelines and
expectations related to the ATV:Aβ program, including the
therapeutic potential benefit ATV:Aβ; ATV:Aβ’s ability to treat
Alzheimer's disease, and the commercial potential of ATV:Aβ; the
potential benefits of, likelihood of success of, and expectations
related to Denali's collaboration with Biogen, including potential
milestone or royalty payments; and statements made by Denali’s CSO.
Actual results are subject to risks and uncertainties and may
differ materially from those indicated by these forward-looking
statements as a result of these risks and uncertainties, including
but not limited to, risks related to: Denali’s transition to a late
stage clinical drug development company; Denali’s and its partners’
ability to initiate, enroll patients in, conduct, and complete its
ongoing and future clinical trials on expected timelines; Denali’s
reliance on third parties for the manufacture and supply of its
product candidates for clinical trials; the potential for clinical
trial results of ATV:Aβ to differ from preclinical, preliminary or
expected results; risks related to Denali’s collaborations; the
risk that results from early clinical biomarker studies will not
translate to clinical benefit in late clinical studies; the risk
that ATV:Aβ may not in the future receive regulatory approval as a
treatment for Alzheimer’s or other indications for which it is
being developed; Denali’s ability to obtain, maintain, or protect
intellectual property rights related to its product candidates;
implementation of Denali’s strategic plans for its business,
product candidates and BBB platform technology; and other risks. In
light of these risks, uncertainties, and assumptions, the
forward-looking statements in this press release are inherently
uncertain and may not occur, and actual results could differ
materially and adversely from those anticipated or implied in the
forward-looking statements. Accordingly, you should not rely upon
forward-looking statements as predictions of future events.
Information regarding additional risks and uncertainties may be
found in Denali’s Annual Report on Form 10-K filed with the SEC on
February 27, 2023, and Denali’s future reports to be filed with the
SEC. The forward-looking statements in this press release are based
on information available to Denali as of the date hereof. Denali
disclaims any obligation to update any forward-looking statements,
except as required by law.
MEDIA CONTACT(S):BiogenJack Cox+ 1 210 544
7920public.affairs@biogen.comDenali
TherapeuticsAngela Salerno-Robin(212)
445-8219asalerno-robin@dna-comms.com |
|
INVESTOR CONTACT(S):BiogenChuck Triano+1 781 464
2442IR@biogen.com Denali
TherapeuticsLaura Hansen, Ph.D.(650)
452-2747hansen@dnli.com |
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