Abeona Therapeutics Announces Opening of Commercial Gene & Cell Therapy Manufacturing Facility in Ohio
May 31 2018 - 8:45AM
-- The Elisa Linton Center for Rare Disease
Therapies to support development of advanced gene and cell
therapies for treatment of serious rare diseases
Abeona Therapeutics Inc. (Nasdaq:ABEO), a leading clinical-stage
biopharmaceutical company focused on developing novel gene and cell
therapies for life-threatening rare diseases, announced today the
opening of The Elisa Linton Center for Rare Disease Therapies, the
commercial GMP manufacturing facility for gene and cell therapies
in Cleveland, Ohio. The GMP facility will have the capability to
manufacture clinical and commercial grade products over Abeona’s
multiple programs, including recessive dystrophic epidermolysis
bullosa (RDEB) and Sanfilippo syndrome. The ribbon-cutting
ceremony and first facility walk-through will be held today, May
31, 2018.
“The opening of The Elisa Linton Center for Rare
Disease Therapies is a momentous occasion and underscores Abeona’s
ongoing commitment to transforming patients’ lives,” said Carsten
Thiel, Ph.D., Abeona’s Chief Executive Officer. “Our development of
internal manufacturing capabilities bolsters our position for
commercial readiness as we continue to execute on our vision to
bring these therapies to the patient communities that need
them.”
EB-101 is an autologous, ex-vivo gene-corrected
cell therapy where the COL7A1 gene is inserted into a patient’s own
skin cells (keratinocytes) for the treatment of RDEB, a rare and
devastating skin disorder. ABO-102 is an adeno-associated virus
(AAV)-based gene therapy in development at Abeona for the treatment
of Sanfilippo syndrome type A (MPS IIIA). Both programs were
recently granted the Regenerative Medicine Advanced Therapy (RMAT)
designation by the U.S. Food and Drug Administration (FDA),
emphasizing the unmet need for patients with RDEB and MPS IIIA.
In addition to the production of the EB-101 and
ABO-102 therapies and the AIM™ AAV vector lab, the 6,000 square
foot facility will satisfy the necessary chemistry, manufacturing
and controls (CMC) requirements for commercial development. The
second stage of the Company’s manufacturing strategy has been
initiated with the construction of an additional 20,000 square foot
facility that will be used to further meet the anticipated
commercial demand for development programs in the longer term.
About Abeona: Abeona
Therapeutics Inc. is a clinical-stage biopharmaceutical company
developing cell and gene therapies for life-threatening rare
genetic diseases. Abeona's lead programs include EB-101
(gene-corrected skin grafts) for recessive dystrophic epidermolysis
bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated virus (AAV)
based gene therapy for Sanfilippo syndrome type A (MPS IIIA) and
ABO-101 (AAV-NAGLU), an adeno-associated virus (AAV) based gene
therapy for Sanfilippo syndrome type B (MPS IIIB). Abeona is also
developing ABO-201 (AAV-CLN3) gene therapy for CLN3 disease,
ABO-202 (AAV-CLN1) for treatment of CLN1 disease, EB-201 for
epidermolysis bullosa (EB), ABO-301 (AAV-FANCC) for Fanconi anemia
(FA) disorder and ABO-302 using a novel CRISPR/Cas9-based gene
editing approach to gene therapy for rare blood diseases. In
addition, Abeona is developing a proprietary vector platform, AIM™,
for next generation product candidates. For more information, visit
www.abeonatherapeutics.com.
Investor Contact:Christine
SilversteinSVP, Finance & Investor RelationsAbeona Therapeutics
Inc.+1 (646) 813-4707 csilverstein@abeonatherapeutics.com
Media Contact: Lynn Granito Berry
& Company Public Relations +1 (212)
253-8881 lgranito@berrypr.com
This press release contains certain statements
that are forward-looking 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, and that involve risks
and uncertainties. These statements include statements that the new
facility will produce several gene and cell therapies from our
pipeline aimed to treat life-threatening rare diseases; statements
that the new facility will support the production of gene and cell
therapies for our leading clinical programs, EB-101 and ABO-102;
statements that the facility will have the capability to
manufacture clinical and commercial grade products over multiple
programs; our expectation that the facility will be used to produce
our EB-101 and ABO-102 therapies and our proprietary AIM AAV
vectors used to deliver the therapies and the necessary CMCs; and
our expectation that our existing 6,000 sq. ft. facility and a new
20,000 sq. ft. facility will be used to meet the anticipated
commercial demand for our development programs for the longer
term. We have attempted to identify forward looking
statements by such terminology as “may,” “will,” “anticipate,”
“believe,” “estimate,” “expect,” “intend,” and similar expressions
(as well as other words or expressions referencing future events,
conditions or circumstances), which constitute and are intended to
identify forward-looking statements. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, risks and
uncertainties, including but not limited to continued interest in
our rare disease portfolio, our ability to enroll patients in
clinical trials, the impact of competition, the ability of our
facility to adequately produce our therapies, that we will have a
continued pipeline of gene and cell therapies, the ability to
secure licenses for any technology that may be necessary to
commercialize our products; the ability to achieve or obtain
necessary regulatory approvals; the impact of changes in the
financial markets and global economic conditions, and other
risks as may be detailed from time to time in the Company's Annual
Reports on Form 10-K and quarterly reports on Form 10-Q and other
reports filed by the Company with the Securities and Exchange
Commission. The Company undertakes no obligations to make any
revisions to the forward-looking statements contained in this
release or to update them to reflect events or circumstances
occurring after the date of this release, whether as a result of
new information, future developments or otherwise, except as
required by the federal securities laws.
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