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Abeona Therapeutics Announces Opening of Commercial Gene & Cell Therapy Manufacturing Facility in Ohio

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Thursday, May 31, 2018

CLEVELAND and NEW YORK - 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 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 on 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.

Contacts:
Investor Contact:
Christine Silverstein
SVP, Finance & Investor Relations
Abeona Therapeutics Inc.
+1 (646) 813-4707
csilverstein@abeonatherapeutics.com

Media Contact:
Lynn Granito
Berry & Company Public Relations
+1 (212) 253-8881
lgranito@berrypr.com

Source: Abeona Therapeutics Inc.
2.5
2.5 from 2 votes
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