- In-house facility to produce NAV Technology-based AAV gene
therapies at 2,000 liters scale
- $65 million invested in new
facility, enabling end-to-end control of gene therapy manufacturing
in Montgomery County,
Maryland
ROCKVILLE, Md., June 9, 2022
/PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today is celebrating
the opening of its new Manufacturing Innovation Center gene
therapy manufacturing facility.
"Launching operations at our Manufacturing Innovation Center is
an important milestone in the evolution of REGENXBIO," said
Kenneth T. Mills, President and
Chief Executive Officer of REGENXBIO. "We believe our in-house
manufacturing capabilities will enable us to rapidly transition
production processes across the product lifecycle, and efficiently
advance new AAV Therapeutics from research and early development to
clinical programs to commercial readiness, and into the hands of
patients who may benefit from these potential one-time
administration therapies."
Located in REGENXBIO's 132,000 square foot headquarters in
Rockville, Maryland, the
state-of-the-art good manufacturing practice (GMP) facility will
enable the company to boost manufacturing of NAV Technology-based
adeno-associated virus (AAV) vectors at scales up to 2,000 liters.
The facility will implement REGENXBIO's NAVXpress™ platform
suspension cell culture process, which has demonstrated the ability
to increase product purity and yield.
The GMP facility is designed to meet global clinical and
commercial regulatory standards, and includes two independent bulk
drug substance production suites, a final drug product suite and
integrated quality control labs. REGENXBIO is one of only a few
gene therapy companies worldwide with a GMP facility capable of
production at scales up to 2,000 liters.
"In-house manufacturing is a key differentiator for REGENXBIO as
a leader in gene therapy," said Curran
Simpson, Chief Operations and Technology Officer at
REGENXBIO. "Quality manufacturing is crucial to all stages of AAV
gene therapy development, and we're extremely proud of this
cutting-edge facility and the experienced team we have to lead
these efforts. Bringing our manufacturing in-house allows us to
control the process from beginning to end and provides flexibility
to support a wide range of clinical and commercial needs."
Through December 31, 2021,
REGENXBIO had invested more than $100
million into the buildout of its Rockville headquarters, including more than
$65 million dedicated to the
Manufacturing Innovation Center. In preparation to establish
end-to-end capabilities in gene therapy from research and early
development to commercial ready manufacturing, the company has
hired 200 people over the past two years.
About REGENXBIO
Inc.
REGENXBIO is a leading clinical-stage biotechnology company
seeking to improve lives through the curative potential of gene
therapy. REGENXBIO's NAV Technology Platform, a proprietary
adeno-associated virus (AAV) gene delivery platform, consists of
exclusive rights to more than 100 novel AAV vectors, including
AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV
Technology Platform Licensees are applying the NAV Technology
Platform in the development of a broad pipeline of candidates in
multiple therapeutic areas. REGENXBIO is committed to a "5x'25"
strategy to progress five AAV Therapeutics from our internal
pipeline and licensed programs into pivotal-stage trials or
commercial products by 2025.
Forward-Looking
Statements
This press release includes "forward-looking statements," within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements express a belief, expectation or
intention and are generally accompanied by words that convey
projected future events or outcomes such as "believe," "may,"
"will," "estimate," "continue," "anticipate," "assume," "design,"
"intend," "expect," "could," "plan," "potential," "predict,"
"seek," "should," "would" or by variations of such words or by
similar expressions. The forward-looking statements include
statements relating to, among other
things, REGENXBIO's manufacturing
capabilities. REGENXBIO has based these forward-looking
statements on its current expectations and assumptions and analyses
made by REGENXBIO in light of its experience and its
perception of historical trends, current conditions and expected
future developments, as well as other
factors REGENXBIO believes are appropriate under the
circumstances. However, whether actual results and developments
will conform with REGENXBIO's expectations and
predictions is subject to a number of risks and uncertainties,
including the timing of enrollment, commencement and completion and
the success of clinical trials conducted by REGENXBIO, its
licensees and its partners, the timing of commencement and
completion and the success of preclinical studies conducted
by REGENXBIO and its development partners, the timely
development and launch of new products, the ability to obtain and
maintain regulatory approval of product candidates, the ability to
obtain and maintain intellectual property protection for product
candidates and technology, trends and challenges in the business
and markets in which REGENXBIO operates, the size and
growth of potential markets for product candidates and the ability
to serve those markets, the rate and degree of acceptance of
product candidates, the impact of the COVID-19 pandemic or similar
public health crises on REGENXBIO's business, and other
factors, many of which are beyond the control of REGENXBIO.
Refer to the "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" sections
of REGENXBIO's Annual Report on Form 10-K for the year
ended December 31, 2021, and comparable "risk factors"
sections of REGENXBIO's Quarterly Reports on Form 10-Q
and other filings, which have been filed with the U.S. Securities
and Exchange Commission (SEC) and are available on
the SEC's website at www.sec.gov. All of the
forward-looking statements made in this press release are expressly
qualified by the cautionary statements contained or referred to
herein. The actual results or developments anticipated may not be
realized or, even if substantially realized, they may not have the
expected consequences to or effects on REGENXBIO or its
businesses or operations. Such statements are not guarantees of
future performance and actual results or developments may differ
materially from those projected in the forward-looking statements.
Readers are cautioned not to rely too heavily on the
forward-looking statements contained in this press release. These
forward-looking statements speak only as of the date of this press
release. Except as required by law, REGENXBIO does not
undertake any obligation, and specifically declines any obligation,
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise., Inc. All
other trademarks referenced herein are registered trademarks of
REGENXBIO.
Contacts:
Dana
Cormack
Corporate Communications
dcormack@regenxbio.com
Investors:
Chris Brinzey
ICR Westwicke
339-970-2843
chris.brinzey@westwicke.com
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SOURCE REGENXBIO Inc.