Prevail Therapeutics and Lonza Establish Strategic Collaboration to Develop and Manufacture Prevail's Novel AAV9 Gene Therapy...
October 08 2019 - 2:00AM
Prevail Therapeutics Inc. (Nasdaq: PRVL), a biotechnology company
developing potentially disease-modifying AAV-based gene therapies
for patients with neurodegenerative disorders, and Lonza (SWX:
LONN) today announced that the companies have entered into a
strategic collaboration.
Lonza and Prevail have been working together
since 2018, with an initial focus on process development, towards
the GMP manufacturing of Prevail's two lead programs, PR001 and
PR006. Under this collaboration, focused on the baculovirus/Sf9
production system for gene therapies, Lonza will manufacture
Prevail's pipeline of novel AAV-based gene therapy programs for
patients with neurodegenerative diseases at its gene therapy center
of excellence in Houston, TX.
"Prevail is a brilliant trailblazer and it is a privilege to
partner with them,” said Alberto Santagostino, SVP Head of Cell
& Gene Technologies, Lonza Pharma & Biotech. “This
strategic collaboration reflects both companies' commitment to
fueling the innovation of novel medicines. The partnership combines
Prevail’s frontier science with Lonza’s operational expertise to
support the development and commercialization of potentially
life-changing treatments. Our cell and gene therapy center of
excellence in Houston, TX, will support Prevail in their journey as
they develop and potentially bring to market AAV-based gene
therapies for patients suffering from debilitating
neurodegenerative diseases."
Prevail's pipeline includes PR001, an AAV9-based gene therapy
delivering GBA1, in development for Parkinson’s disease patients
with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease
patients (nGD). Prevail plans to initiate a Phase 1/2 clinical
trial of PR001 in PD-GBA in 2019. The company is also developing
PR006, an AAV9-based gene therapy delivering GRN, for
frontotemporal dementia patients with a GRN mutation (FTD-GRN).
Prevail anticipates PR006 will enter the clinic in 2020. The
collaboration also has the potential to extend to Prevail's future
pipeline of AAV-based gene therapy programs.
"We are pleased to partner with Lonza, a leader
in the manufacturing of AAV gene therapy vectors, to enable
large-scale production of our novel gene therapies that we believe
hold potential to halt the course of neurodegenerative diseases for
patient populations with urgent unmet needs,” said Asa Abeliovich,
M.D., Ph.D., Founder and Chief Executive Officer, Prevail
Therapeutics. “Lonza and Prevail will work together closely on
process development and scaling up production of PR001, our gene
therapy for Parkinson’s disease with GBA1 mutations and
neuronopathic Gaucher disease, to supply late-stage clinical trials
and for commercial production. In addition, we look forward to a
collaborative relationship to support our PR006 gene therapy
program for patients with frontotemporal dementia with GRN
mutations, and for future gene therapy programs in our
pipeline."
Prevail has built in-house process and
analytical development capabilities utilizing both HEK293 and
baculovirus/Sf9 AAV expression systems. Under this collaboration,
Prevail and Lonza will work closely together on process
development, analytical development, and large-scale production
using the baculovirus/Sf9 process for late-stage clinical and
commercial supply at Lonza’s GMP facility in Houston.
About LonzaLonza is an
integrated solutions provider that creates value along the
Healthcare Continuum®. Through our Pharma Biotech & Nutrition
segment and our Specialty Ingredients segment businesses, we
harness science and technology to serve markets along this
continuum. We focus on creating a healthy environment, promoting a
healthier lifestyle and preventing illness through consumers'
preventive healthcare, as well as improving patient healthcare by
supporting our customers to deliver innovative medicines that help
treat or even cure severe diseases.
Patients and consumers benefit from our ability
to transfer our pharma know-how to the healthcare, hygiene and
fast-moving consumer goods environment and to the preservation and
protection of the world where we live.
Founded in 1897 in the Swiss Alps, Lonza today
is a well-respected global company with more than 100 sites and
offices and approximately 15,500 full-time employees worldwide at
the end of 2018. The company generated sales of CHF 5.5 billion in
2018 with a CORE EBITDA of CHF 1.5 billion. Further information can
be found at www.lonza.com.
About Prevail Therapeutics
Prevail is a gene therapy company leveraging breakthroughs in human
genetics with the goal of developing and commercializing
disease-modifying AAV-based gene therapies for patients with
neurodegenerative diseases. Prevail was founded by Dr. Asa
Abeliovich in 2017, through a collaborative effort
with The Silverstein Foundation for Parkinson’s with GBA
and OrbiMed, and is headquartered in New York, NY.
Forward-Looking Statements Related to
PrevailStatements contained in this press release
regarding matters that are not historical facts are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended. Examples of
these forward-looking statements include statements concerning: the
potential of Prevail’s gene therapies to halt the course of
neurodegenerative diseases; the anticipated timing of Prevail’s
Phase 1/2 clinical trial of PR001 in PD-GBA and Prevail’s clinical
trial of PR006; Prevail’s ability to work with Lonza to supply
Prevail’s late stage trials and commercial production; and the
applicability of the collaboration to Prevail’s future pipeline of
AAV-based gene therapy programs. Because such statements are
subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. These risks and uncertainties include, among others:
Prevail’s novel approach to gene therapy makes it difficult to
predict the time, cost and potential success of product candidate
development or regulatory approval; Prevail’s gene therapy programs
may not meet safety and efficacy levels needed to support ongoing
clinical development or regulatory approval; the regulatory
landscape for gene therapy is rigorous, complex, uncertain and
subject to change; and the fact that gene therapies are novel,
complex and difficult to manufacture. These and other risks are
described more fully in Prevail’s filings with the Securities and
Exchange Commission (SEC), including the “Risk Factors” section of
the Company’s Quarterly Report on Form 10-Q for the period ended
June 30, 2019, filed with the SEC on August 14, 2019, and its other
documents subsequently filed with or furnished to the SEC. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Except to the extent
required by law, Prevail undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Additional Information and
DisclaimerLonza Group Ltd has its headquarters in Basel,
Switzerland, and is listed on the SIX Swiss Exchange. It has a
secondary listing on the Singapore Exchange Securities Trading
Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s
continuing listing requirements but remains subject to Rules 217
and 751 of the SGX-ST Listing Manual.
Certain matters discussed in this news release
may constitute forward-looking statements. These statements are
based on current expectations and estimates of Lonza Group Ltd,
although Lonza Group Ltd can give no assurance that these
expectations and estimates will be achieved. Investors are
cautioned that all forward-looking statements involve risks and
uncertainty and are qualified in their entirety. The actual results
may differ materially in the future from the forward-looking
statements included in this news release due to various factors.
Furthermore, except as otherwise required by law, Lonza Group Ltd
disclaims any intention or obligation to update the statements
contained in this news release.
Media Contact:Katie
Engleman1ABkatie@1ABmedia.com
Investor
Contact:investors@prevailtherapeutics.com
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