Collaborations to provide Voyager the ability and
flexibility to transfer its manufacturing expertise across multiple
high-quality vendors to support the development of its pipeline
programs
Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene
therapy company focused on developing life-changing treatments for
severe neurological diseases, today announced that it has entered
into collaborations with Brammer Bio (Brammer) and Fujifilm
Diosynth Biotechnologies (Fujifilm) to further expand Voyager’s
manufacturing capabilities to support the development of its
gene therapy programs. The collaborations allow Voyager to transfer
its state-of-the-art research and development production
capabilities to best-in-class gene therapy contract development and
manufacturing organizations (CDMO) with late-stage clinical and
commercial-scale capabilities, particularly as it relates to the
baculovirus/Sf9 system for manufacturing adeno-associated virus
(AAV) gene therapies.
“Collaborating with Brammer and Fujifilm fits
squarely within our manufacturing strategy to build strong internal
preclinical and clinical processes, analytical development, and
scale-up expertise and to partner with quality CDMOs for larger
scale, redundant supply and commercial-stage capacity,” said Luis
Maranga, Ph.D., chief technical operations officer at Voyager
Therapeutics. “Brammer and Fujifilm have recently completed
renovations and launches of late-stage and commercial-ready
facilities for gene therapy products in Cambridge, Massachusetts
and College Station, Texas, respectively, and we are ready to begin
working with them to support the advancement of our pipeline
programs.”
Voyager’s manufacturing and related intellectual
property strategy focuses on developing internal processes and
capabilities to produce high-yield and high-quality gene therapies,
including the use of the baculovirus/Sf9 AAV production system,
with the potential to transfer these capabilities to increase
capacity and scale through the use of external CDMOs. As part of
today’s announcement, Voyager will partner with Brammer to
implement a commercial-ready manufacturing process under current
good manufacturing practice (cGMP) at their Cambridge facility, and
will partner with Fujifilm to provide first-in-human cGMP clinical
trial material production capacity at their College Station
facility.
"Today’s announcement with Voyager represents a
continued commitment to our vision to enable innovators to bring
advanced medicines to patients," said Mark Bamforth, president and
chief executive officer of Brammer. "Our recently announced
progress on a three-year, $200 million investment program to
establish over 30 suites for clinical and commercial viral vector
supply in Alachua, Florida, and Cambridge and Lexington,
Massachusetts, by 2019, uniquely positions Brammer to support the
dramatic anticipated growth of the gene and cell therapy sector,
including Voyager’s pipeline of AAV gene therapy programs."
“We are thrilled to begin working with Voyager
and to be a contributor to the development of their gene therapy
pipeline,” said Gerry Farrell, chief operating officer of Fujifilm
Diosynth Biotechnologies, Texas. “These therapies have the
potential of transforming patients’ lives and, as an organization,
we are delighted to support our partners as they advance tomorrow’s
medicines.”
Voyager Therapeutics’ Recent
Manufacturing Data at ASGCT/ESGCT
Voyager’s manufacturing platform utilizes a
baculovirus/Sf9 cell production process that enables the production
of AAV vectors at clinical and commercial scale, with the potential
for increased yields over traditional production processes.
Presentations at this year’s American Society for Gene and Cell
Therapy (ASGCT) conference in May (link here) included data from a
cleared investigational new drug (IND) application for Voyager’s
VY-AADC for Parkinson’s disease demonstrating comparability between
VY-AADC produced under (GMP) using Voyager’s baculovirus/Sf9
manufacturing process and VY-AADC produced using a mammalian cell
system consisting of triple-transfection of human embryonic kidney
(HEK293) cells. These data demonstrated that the baculovirus/Sf9
production system can be used to produce AAV vectors that are
comparable with respect to bio-distribution, potency and expression
in vivo compared to AAV vectors produced in mammalian cells.
Data at this year’s European Society for Gene
and Cell Therapy (ESGCT) conference in October (link here) further
demonstrated Voyager’s strong molecular biology capabilities and
robustness of the baculovirus/Sf9 platform to produce high quality
AAV gene therapies through various methodologies including precise
modulation of novel capsid protein stoichiometry.
About Voyager Therapeutics
Voyager Therapeutics is a clinical-stage gene
therapy company focused on developing life-changing treatments for
severe 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. Voyager’s pipeline focuses on severe
neurological diseases in need of effective new therapies, including
Parkinson’s disease, a monogenic form of ALS called SOD1,
Huntington’s disease, Friedreich’s ataxia, neurodegenerative
diseases related to defective or excess aggregation of tau protein
in the brain including Alzheimer’s disease and severe, chronic
pain. Voyager has broad strategic collaborations with Sanofi
Genzyme, the specialty care global business unit of Sanofi, AbbVie,
and the University of Massachusetts Medical School. Founded
by scientific and clinical leaders in the fields of AAV gene
therapy, expressed RNA interference and neuroscience, Voyager
Therapeutics is headquartered in Cambridge, Massachusetts.
Forward-Looking Statements
This 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 initiation, timing, progress
and reporting of results of its preclinical programs and clinical
trials and its research and development programs, its ability to
advance its AAV-based gene therapies into, and successfully
initiate, enroll and complete, clinical trials, the potential
clinical utility of its product candidates, its ability to continue
to develop its gene therapy platform, its ability to develop
manufacturing capability for its products and successfully
transition its manufacturing process including the transition of
its baculovirus/Sf9 production system to Brammer and Fujifilm, its
ability to perform under existing collaborations with, among
others, Sanofi Genzyme and AbbVie and manufacturers Brammer and
Fujifilm and to add new programs to its pipeline, its ability to
enter into new partnerships or collaborations, the sufficiency of
its cash resources and the regulatory pathway of, and the timing or
likelihood of its regulatory filings and approvals for, any of its
product candidates, are forward looking. All forward-looking
statements are based on estimates and assumptions by Voyager’s
management that, although Voyager believes 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 initiation and conduct of
preclinical studies and clinical trials; the availability of data
from clinical trials; the expectations for regulatory
communications, submissions and approvals; the continued
development of the gene therapy platform; Voyager’s scientific
approach and general development progress; Voyager’s ability to
transfer technology successfully to contract development and
manufacturing organizations and the ability of such organizations
to manufacture at clinical and commercial scale; 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. Any forward-looking
statement speaks only as of the date on which it was made. Voyager
undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise, except as required by law.
Investor Relations: Matt
OsborneVice President of Investor Relations & Corporate
Communications857-259-5353mosborne@vygr.com
Media: Sheryl Seapy W2O
Group949-903-4750sseapy@w2ogroup.com
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