Voyager Therapeutics Announces License Option Agreement with Pfizer for Next-Generation TRACERᵀᴹ AAV Capsids to Enable Neurologic and Cardiovascular Gene Therapy Programs
October 06 2021 - 7:00AM
Voyager Therapeutics, Inc. (Nasdaq: VYGR), a gene therapy company
developing life-changing treatments and next-generation
adeno-associated virus (AAV) platform technologies, today announced
an agreement through which Pfizer Inc (NYSE: PFE) may exercise
options to license novel capsids generated from Voyager’s
RNA-driven TRACERTM (Tropism Redirection of AAV by
Cell-type-specific Expression of RNA) screening technology as part
of Pfizer’s efforts to develop, manufacture, and commercialize gene
therapies, utilizing two undisclosed transgenes to treat certain
neurologic and cardiovascular diseases.
“This transaction highlights the potential of our TRACER
platform to identify novel AAV capsids that target desired cells
and tissues with greater specificity at lower doses and with fewer
off-target risks than conventional AAV serotypes,” said Michael
Higgins, Interim CEO of Voyager. “We believe that our TRACER
platform has the ability to produce not only enhanced
blood-brain-barrier penetrant capsids, but also novel capsids with
enhanced tropisms across a diversity of tissues and cell types,
offering promise to unlock the fullest potential of gene therapies
for a wide array of diseases with unmet medical need.”
"Our collaboration with Voyager will provide Pfizer with access
to additional AAV capsids that may help further advance our
industry-leading gene therapy portfolio,” said Seng Cheng, Ph.D.,
Senior Vice President and Chief Scientific Officer of Pfizer's Rare
Disease Research Unit. “We are impressed with Voyager’s results to
date and are enthusiastic about the potential to utilize these
novel capsids to help accelerate the development of new therapeutic
options for patients living with certain neurologic and
cardiovascular diseases.”
Proprietary AAV capsids derived from Voyager’s TRACER platform
have demonstrated superior blood-brain-barrier penetration,
enhanced cardiac muscle tropism, and increased transgene expression
in target tissues compared to conventional AAV capsids as measured
in non-human primates (NHPs). Voyager presented data at the 24th
Annual Meeting of the American Society of Gene and Cell Therapy for
one capsid candidate demonstrating more than 1,000-fold increased
transgene expression compared to conventional AAV9 across a wide
array of brain regions when dosed intravenously in NHPs. Results
presented also included another capsid candidate showing
significantly enhanced cardiac muscle transduction and dorsal root
ganglia de-targeting compared to conventional AAV9. Voyager is
performing further screening with its TRACER platform to identify
additional proprietary AAV capsids targeting multiple tissue and
cell types for use in gene therapies to treat a broad range of
diseases.
Under the terms of the agreement, Pfizer will have the right to
evaluate novel capsids selected for central nervous system and
cardiac tropisms from Voyager’s TRACER platform and to exercise
options to license capsids for exclusive use in Pfizer’s
development of AAV gene therapies incorporating two undisclosed
transgenes. These transgenes will be distinct from those planned
for Voyager’s internal pipeline. Voyager will retain global rights
to all licensed capsids for use with other transgenes and to all
other applications of its TRACER technology.
Voyager will receive $30 million upfront and is entitled to
receive up to $20 million in exercise fees for two options,
exercisable by Pfizer within 12 months of signing. In addition,
Voyager will be eligible to earn up to $580 million in total
development, regulatory, and commercial milestones associated with
licensed products incorporating the two undisclosed Pfizer
transgenes together with a Voyager licensed capsid. Voyager is also
eligible to receive mid- to high-single-digit tiered royalties
based on net sales of Pfizer’s products incorporating the licensed
capsids.
About the TRACER AAV Capsid Discovery
PlatformVoyager’s TRACER system is a broadly applicable,
RNA-based functional screening platform that allows for rapid in
vivo evolution of AAV capsids with enhanced tropisms and cell- and
tissue-specific transduction properties in multiple species,
including non-human primates (NHPs). Initial data from the first of
many libraries screened in NHPs demonstrated the proprietary capsid
variants effectively penetrated the blood-brain barrier and
achieved widespread biodistribution and transduction of multiple
regions of the brain. Separate results have demonstrated the
ability of certain capsids to transduce cardiac muscle and to
de-target the dorsal root ganglia. Voyager is proceeding with
additional capsid campaigns derived from AAV9 and other capsid
serotypes to identify novel AAV vectors optimized for specific
therapeutic applications.
About Voyager TherapeuticsVoyager Therapeutics
(Nasdaq: VYGR) is leading the next generation of AAV gene therapy
to unlock the potential of the technology to treat devastating
diseases. Proprietary capsids born from the Company’s TRACER
screening platform are powering a rich early-stage pipeline of new
and second-generation programs and may elevate the field to
overcome the limitations of conventional gene therapy vectors
across neurologic disorders and other therapeutic areas.
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Forward-Looking StatementsThis press release
contains forward-looking statements for the purposes of the safe
harbor provisions under The Private Securities Litigation Reform
Act of 1995 and other federal securities laws. The use of words
such as “may,” “might,” “will,” “would,” “should,” “expect,”
“plan,” “anticipate,” “believe,” “estimate,” “undoubtedly,”
“project,” “intend,” “future,” “potential,” or “continue,” and
other similar expressions are intended to identify forward-looking
statements.
For example, all statements Voyager makes regarding Voyager’s
ability to continue to identify and develop proprietary capsids
from its TRACER AAV screening platform; Voyager’s ability to
identify and develop proprietary capsids from its TRACER AAV
screening platform with increased transgene expression, increased
blood-brain barrier penetration and increased biodistribution
compared to conventional AAV9 capsids; Voyager’s ability to utilize
its novel proprietary capsids in its own product development
programs; Voyager’s ability to attract parties to license its novel
proprietary capsids or to participate with Voyager in research and
development collaborations utilizing its novel proprietary capsid;
Voyager’s ability to advance its AAV-based gene therapy programs;
Voyager’s ability to perform its obligations under its license
option agreement with Pfizer; Voyager’s entitlement to receive
upfront, milestone and royalty based fees from Pfizer under the
license option agreement; Voyager’s ability to enter into new
partnerships or collaborations; and Voyager’s ability to generate
sufficient cash resources to enable it to continue to identify and
develop proprietary capsids from its TRACER AAV screening platform
are forward looking.
All forward-looking statements are based on estimates and
assumptions by Voyager’s management that, although Voyager believes
such forward-looking statements to be reasonable, are inherently
uncertain. All forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those that Voyager expected. Such risks and uncertainties
include, among others, the severity and length of the COVID-19
health crisis, the imposition of governmental controls and guidance
addressing the COVID health crisis, and the financial and human
resources available to Voyager to manage the COVID-19 health
crisis; the continued development of various technology platforms,
including Voyager’s TRACER platform; Voyager’s scientific approach
and general development progress; the ability to attract and retain
talented contractors and employees; the ability to create and
protect intellectual property; the sufficiency of cash resources;
the possibility or the timing of the exercise of development,
commercialization, license and other options under the Pfizer
license option agreement and other collaborations; the ability of
Voyager to negotiate and complete licensing or collaboration
agreements on terms acceptable to Voyager and third parties; and
the availability or commercial potential of Voyager’s product
candidates. These statements are also subject to a number of
material risks and uncertainties that are described in Voyager’s
most recent Annual Report on Form 10-K filed with the Securities
and Exchange Commission, as updated by its subsequent filings with
the Securities and Exchange Commission. All information in the
press release is as of the date of this press release, and any
forward-looking statement speaks only as of the date on which it
was made. Voyager undertakes no obligation to publicly update or
revise this information or any forward-looking statement, whether
as a result of new information, future events or otherwise, except
as required by law.
Voyager
ContactsInvestorsInvestors@voyagertherapeutics.comMediaScott
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