SAN FRANCISCO, April 23, 2019 /PRNewswire/ -- Audentes
Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic
medicines company focused on developing and commercializing
innovative products for serious rare neuromuscular diseases, today
announced the launch of a new state-of-the-art, internal cGMP
plasmid manufacturing facility in South
San Francisco. This new internal capability is expected
to significantly enhance a critical element of the company's
supply chain, providing high-quality nonclinical and cGMP-grade
plasmids for all of its development programs.
"Four years ago, we began investing in our own industry-leading
AAV manufacturing capability, which has proven to be a key
competitive advantage, enabling us to rapidly progress our pipeline
of promising product candidates," stated Natalie Holles, President and Chief Operating
Officer. "The addition of an internal plasmid manufacturing
operation should further improve control over our supply chain,
reduce costs, and significantly decrease the time it takes to
advance our programs from discovery through to clinical
development, and ultimately commercialization."
Ensuring access to a reliable supply of high-quality plasmids is
a critical aspect of gene therapy development. The new facility
supports the company's rapidly advancing neuromuscular pipeline
including the potential commercialization of AT132 for the
treatment of X-linked Myotubular Myopathy.
The plasmid manufacturing facility is the latest addition to the
company's proprietary AAV gene therapy technology platform, which
consists of end-to-end internal expertise from vector construct
engineering and small-scale research production to state-of the-art
large-scale cGMP manufacturing. Internal process and analytical
development, fill-finish, and quality control testing capabilities
complete the fully-integrated approach to production and release of
product candidates for clinical and commercial use. The company's
current 1,000-liter scale manufacturing operation provides
sufficient capacity for global commercialization of AT132, as well
as continued clinical development of pipeline programs, and the
facility is sized for expansion to add an additional 8,000 liters
of production capacity over time.
About Audentes Therapeutics, Inc.
Audentes
Therapeutics (Nasdaq: BOLD) is a leading AAV-based genetic
medicines company focused on developing and commercializing
innovative products for serious rare neuromuscular
diseases. We are leveraging our AAV gene therapy technology
platform and proprietary manufacturing expertise to develop
programs across three modalities: gene replacement, vectorized exon
skipping, and vectorized RNA knockdown. Our product candidates
are showing promising therapeutic profiles in clinical and
preclinical studies across a range of neuromuscular diseases.
Audentes is a focused, experienced and passionate team driven by
the goal of improving the lives of patients.
For more information regarding Audentes, please visit
www.audentestx.com.
Forward Looking Statements
This press release
contains forward-looking statements within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995, including, but not limited to, expected supply chain
improvements, cost reductions and shorter research, development and
commercialization timelines, expected timing for final agreement on
regulatory submission pathways for AT132, potential
commercialization of AT132 and sufficiency of manufacturing
capacities. All statements other than statements of historical
fact are statements that could be deemed forward-looking
statements. Although the company believes that the
expectations reflected in such forward-looking statements are
reasonable, the company cannot guarantee future events, results,
actions, levels of activity, performance or achievements, and the
timing and results of biotechnology development and potential
regulatory approval is inherently uncertain. Forward-looking
statements are subject to risks and uncertainties that may cause
the company's actual activities or results to differ significantly
from those expressed in any forward-looking statement, including
risks and uncertainties related to the company's ability to advance
its product candidates, obtain regulatory approval of and
ultimately commercialize its product candidates, the timing and
results of preclinical and clinical trials, the company's ability
to fund development activities and achieve development goals, the
company's ability to protect intellectual property and other risks
and uncertainties described under the heading "Risk Factors" in
documents the company files from time to time with the Securities
and Exchange Commission. These forward-looking statements speak
only as of the date of this press release, and the company
undertakes no obligation to revise or update any forward-looking
statements to reflect events or circumstances after the date
hereof.
Audentes Contacts:
Investor Contact:
Andrew Chang
415.818.1033
achang@audentestx.com
Media Contacts:
Sarah Spencer
415.957.2020
sspencer@audentestx.com
Katie Hogan
415.951.3398
khogan@audentestx.com
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SOURCE Audentes Therapeutics, Inc.