Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage
gene therapy company focused on developing life-changing treatments
for serious neurological diseases, today announced key leadership
transitions and a strategic shift toward a refocused pipeline and
expanded investment in its innovative, next-generation AAV capsid
platform, TRACER (Tropism Redirection of AAV by Cell-type-specific
Expression of RNA). The Company expects its TRACER technology
platform to enable development of novel gene therapy candidates for
serious neurological diseases that have been challenging to address
with conventional approaches.
Michael Higgins, chairman of the board of directors, will assume
the role of interim chief executive officer (CEO) and Glenn Pierce,
M.D., Ph.D., board director, will assume the role of interim chief
scientific officer (CSO). Mr. Higgins succeeds Andre
Turenne, who has decided to step down from his roles as
president and CEO and as a board director, effective in early June,
to pursue new opportunities. Mr. Turenne will support the Company
in an advisory capacity as the Company searches for a permanent
CEO. Voyager also announced that Omar Khwaja, M.D., Ph.D., has
resigned from his role as chief medical officer (CMO) and head of
research and development, effective at the end of May. Dr. Khwaja
will be returning to Europe to pursue a new scientific and clinical
leadership opportunity. Maria Lopez-Bresnahan, M.D., SVP of
translational medicine and clinical development, will continue to
lead the Company’s clinical development programs, including the
Company’s program for Huntington’s disease.
“On behalf of the entire Board, I want to thank Andre and Omar
for their significant and dedicated contributions to the Company.
We wish them success with their next endeavors,” said Michael
Higgins, incoming CEO.
“I am proud of our collective accomplishments, especially in the
development of Voyager’s platform technology and the progress made
in moving VY-HTT01 toward clinical studies. I have great confidence
in the outstanding team at Voyager and wish them all the best in
their important work developing new treatments for severe
neurological diseases,” said Mr. Turenne. “It has been a privilege
to be part of Voyager, and I look forward to the Company’s
continued progress towards delivering solutions for patients in
need.”
Mr. Higgins added, “This is a transformational time for Voyager.
We believe that our TRACER technology platform has the potential to
generate novel capsids that will enable the treatment of a broad
range of diseases that today cannot be safely and effectively
addressed with current AAV delivery. We believe the novel capsids
will allow Voyager to create highly differentiated, next-generation
AAV gene therapies for serious neurological diseases and enable
licensing and partnership opportunities both inside and outside of
the neurology space. We anticipate an eventful year ahead with the
initiation of our planned Phase 1/2 clinical trial for VY-HTT01 for
Huntington’s disease, the expected advancement of our earlier stage
pipeline programs powered by our novel capsids, further investment
in TRACER and other vector engineering technology, and potential
strategic partnership and licensing deals.”
“Voyager has made tremendous progress identifying innovative
gene therapy approaches for serious neurological diseases,
including the ability to deliver diverse therapeutic payloads
directly to targeted areas of the brain,” said Dr. Khwaja. “I am
particularly excited by the possibilities created by the TRACER
platform, and by the appointment of Glenn Pierce, a widely
respected expert in gene therapy development, to lead Voyager’s
team of world-class scientists and clinicians as they advance these
technologies and programs towards the clinic.”
At the recent ASGCT meeting, the Company presented key data in
non-human primates (NHPs) demonstrating that one of its novel
capsids, 9P801, after intravenous dosing, resulted in more than
1,000-fold or higher transgene expression in the brain, and
100-fold higher transgene expression in the spinal cord, compared
to AAV9. Data showed the Company’s novel capsid variants
effectively penetrated the blood brain barrier and achieve
widespread biodistribution and transduction of multiple regions of
the brain including the cortex, thalamus, striatum, cerebellum,
brainstem and spinal cord. These results arose from the first of
many libraries screened in NHPs, and the Company is rapidly
processing additional NHP campaigns from AAV9 and other parental
capsids.
The Company also recently announced IND clearance of VY-HTT01,
its gene therapy candidate for the treatment of Huntington’s
disease and confirmed its expectation to proceed with VYTAL, its
planned Phase 1/2 clinical trial, in the fourth quarter of
2021.
Incoming Interim Leadership
Michael Higgins has served on Voyager’s board of directors since
July 2015 and has been chair of the board since June 2019. He is
also the chair of the board of Pulmatrix and a board member for
Genocea Biosciences, Nocion Therapeutics, Camp4 Therapeutics and
Sea Pharmaceuticals. Previously, Michael served as
entrepreneur-in-residence at Polaris Partners, senior vice
president and chief operating officer of Ironwood Pharmaceuticals
and held a variety of senior business positions at Genzyme. Michael
has a B.S. from Cornell University and an M.B.A. from the Amos Tuck
School of Business Administration at Dartmouth College.
Glenn Pierce, M.D., Ph.D., has been a member of the board of
directors since January 2017. He serves as
entrepreneur-in-residence at Third Rock Ventures. At Third Rock
Ventures, he co-founded Ambys Medicines and serves as interim chief
medical officer. Glenn previously served in a number of roles at
Biogen, most recently as chief medical officer leading the
hematology, cell and gene therapies division. Prior to Biogen, he
served in small and large, public and private biopharmaceutical
firms, including Bayer, Inspiration, Avigen, Selective Genetics and
Amgen in the areas of tissue regeneration and hematology. Glenn is
the co-author of more than 150 scientific papers and has received
more than 15 patents. He currently serves on the boards of
directors of Global Blood Therapeutics and the World Federation of
Hemophilia as the vice president, Medical. Dr. Pierce received an
M.D. and a Ph.D. in immunology, both from Case Western Reserve
University in Cleveland, and completed his postgraduate training in
pathology and hematology research at Washington University in St.
Louis.
The Company’s Board has commenced a search process to identify a
permanent chief executive officer and chief scientific officer.
About Voyager TherapeuticsVoyager
Therapeutics is a clinical-stage gene therapy company focused
on developing life-changing treatments for serious neurological
diseases. Voyager is committed to advancing the field of AAV gene
therapy through innovation and investment in vector engineering and
optimization, manufacturing, and dosing and delivery techniques.
For more information on Voyager Therapeutics, please visit the
company’s website at www.voyagertherapeutics.com or
follow @VoyagerTx on Twitter and LinkedIn.
Voyager Therapeutics® is a registered trademark, and TRACER™ is
a trademark, of Voyager Therapeutics, Inc.
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 the
effective date for the resignation of Mr. Turenne and Dr. Khwaja
from their current roles at Voyager; the assumption of interim
roles by Mr. Higgins and Dr. Pierce at Voyager; the capabilities of
Voyager’s novel capsids to treat a broad range of diseases; the
initiation of the planned phase 1/2 clinical trial for VY-HTT01 for
Huntington's disease; the expected advancement of earlier stage
pipeline programs; the potential for TRACER to prove on an ongoing
basis its ability to advance gene therapy approaches; the ability
of Voyager's differentiated technology to provide strategic
opportunities; and the ability for the Voyager to successfully
recruit a new chief executive officer and chief scientific officer,
in each instance are forward looking statements.
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 ability of Voyager’s interim executive officers
to successfully transition to their new roles; the ability of
Voyager to recruit experienced and expert senior executive officers
in a competitive environment; the ability of Voyager to continue
development of the TRACER system; the success of the TRACER system
to identify AAV novel capsids that have utility in gene therapy for
the treatment of neurological diseases and for other diseases; the
ability to engage investigators, to recruit patients meeting
eligibility requirements, to manage COVID-19 restrictions and to
generate clinical outcomes and data in a timely manner for the
VYTAL study; the ability of Voyager to manage the business
disruptions resulting from COVID-19 health crisis; the ability of
Voyager to create research and development programs combining
sufficient levels of scientific interest and applied expertise to
be attractive in recruiting and maintaining researchers and
scientists; Voyager’s scientific approach and general development
progress; the ability to create and protect intellectual property;
and the sufficiency of cash resources to support Voyager’s
programs.
These statements are also subject to a number of material risks
and uncertainties that are described in Voyager’s Annual Report on
Form 10-K for the year ended December 31, 2020, 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.
Investor Inquiries:
investors@voyagertherapeutics.com
Media Inquiries: Lissette SteeleVerge
Scientific Communications202.930.4762 x
409lsteele@vergescientific.com
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