Axovant and Viralgen Sign Strategic Gene Therapy Development and Manufacturing Partnership
September 15 2020 - 8:00AM
Axovant Gene Therapies Ltd (NASDAQ: AXGT), a clinical-stage company
developing innovative gene therapies for neurological diseases,
today announced that it has signed a strategic partnership with
Viralgen, a leading Contract Development and Manufacturing
Organization (CDMO). Leveraging the technology platforms of AskBio,
Viralgen is able to support all aspects of manufacturing for
Axovant’s AAV programs, including large-scale manufacturing,
fill-finish, and quality control in a GMP-certified environment
custom-designed to bring therapies to market as quickly as
possible. Under the terms of the partnership, Axovant will have
access to manufacturing resources for Axovant’s AAV-based gene
therapy programs, AXO-AAV-GM1 for GM1 gangliosidosis and
AXO-AAV-GM2 for GM2 gangliosidosis (also known as
Tay-Sachs/Sandhoff disease) with sufficient capacity to support
ongoing development and eventual commercialization.
"We are pleased to partner with Viralgen, an emerging leader in
the manufacturing of AAV-based gene therapies, to enable
commercial-scale production of our novel gene therapies that we
believe hold potential to stabilize or improve the course of GM1
and GM2 gangliosidoses, two devastating pediatric diseases with no
approved treatment options,” said Gavin Corcoran, M.D., Chief
R&D Officer of Axovant. “Our partnership with Viralgen provides
us access to an expansive facility and a highly skilled team
focused on delivering technology that can accelerate the
development of life-saving therapeutics. This approach is crucial
as we continue to advance our AAV programs where data from the
ongoing Phase 1/2 clinical study of AXO-AAV-GM1 is expected in Q4
2020 and we anticipate IND clearance of the AXO-AAV-GM2 IND
application before year end.”
Javiér Garcia, Chief Executive Officer of Viralgen, said, “We
are thrilled to partner with Axovant and look forward to providing
support and priority access to our platform as they advance their
AAV gene therapies for the rare fatal pediatric diseases GM1 and
GM2 gangliosidosis. Viralgen’s flexible and scalable production
platform will be an ideal complement to Axovant’s
development efforts from clinical trials through to
commercialization to advance potential cures for patients in
need.”
About Axovant Gene
Therapies
Axovant Gene Therapies is a clinical-stage gene
therapy company focused on developing a pipeline of innovative
product candidates for debilitating neurodegenerative diseases. Our
current pipeline of gene therapy candidates targets GM1
gangliosidosis, GM2 gangliosidosis (also known as Tay-Sachs disease
and Sandhoff disease), and Parkinson’s disease. Axovant is focused
on accelerating product candidates into and through clinical trials
with a team of experts in gene therapy development and through
external partnerships with leading gene therapy organizations. For
more information, visit www.axovant.com.
About Viralgen
Founded in 2017 as a joint venture between
AskBio and Columbus Venture Partners (a Spanish venture capital
group), Viralgen is a world-class AAV cGMP. Viralgen licenses
AskBio's Pro10™ cell line technology that allows for greater scale,
higher yields and increased accuracy of AAV therapeutics. Based at
the Miramon Parke in San Sebastián, Spain, Viralgen is a CDMO
(Contract Development and Manufacturing Organization) that produces
AAV gene therapy treatments to enable pharmaceutical and
biotechnology companies to accelerate the delivery of novel
treatments to improve patient lives.
A key benefit of our technology is the cGMP production of
high-quality rAAV in large batches through a unique and robust
manufacturing platform. Viralgen’s clinical facility, with 3 suites
operating between 50 and 500L are able to supply customers until
commercialization. Commercial supply will be provided from a new
facility, under construction now and available in late 2021 for
production up to 2000L. All facilities support integrated fill
finish and quality control for full support of client projects
using the Pro10 platform.
For more information, visit www.viralgenvc.com.
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," "believe," "estimate," and other similar expressions are
intended to identify forward-looking statements. For example, all
statements Axovant makes regarding costs associated with its
operating activities are forward-looking. All forward-looking
statements are based on estimates and assumptions by Axovant’s
management that, although Axovant 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 Axovant expected. Such risks and
uncertainties include, among others, the impact of the Covid-19
pandemic on our operations, the initiation and conduct of
preclinical studies and clinical trials; the availability of data
from clinical trials; the scaling up of manufacturing, the
expectations for regulatory submissions and approvals; the
continued development of its gene therapy product candidates and
platforms; Axovant’s scientific approach and general development
progress; and the availability or commercial potential of Axovant’s
product candidates. These statements are also subject to a number
of material risks and uncertainties that are described in Axovant’s
most recent Annual Report on Form 10- Q filed with
the Securities and Exchange Commission on August 11,
2020, 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. Axovant undertakes no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
Contacts:
Media & Investors
Parag MeswaniAxovant Gene Therapies Ltd.(212)
547-2523media@axovant.cominvestors@axovant.com
Viralgen Communicationcomunicacion@sg-branding.com
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