Abeona Therapeutics Appoints Head of Research & Clinical Development
Abeona Therapeutics Inc. (Nasdaq: ABEO) has appointed Vishwas Seshadri, Ph.D., M.B.A., as Senior Vice President and Head of Research & Clinical Development, effective June 1, 2021. Dr. Seshadri brings over 20 years of experience in the life sciences industry, previously serving at Celgene (BMS). He will lead Abeona's research and clinical programs, overseeing preclinical efforts and regulatory strategy. Notably, the company anticipates a Type B meeting with the FDA in June 2021 regarding the ABO-102 study, which could pave the way for a Biologics License Application for MPS IIIA.
- Appointment of Vishwas Seshadri as Senior VP Head of Research & Clinical Development brings over 20 years of experience.
- Dr. Seshadri is expected to enhance clinical programs and oversee pivotal studies.
- Upcoming Type B meeting with FDA for ABO-102 may facilitate progress toward a Biologics License Application.
- None.
NEW YORK and CLEVELAND, May 25, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Vishwas Seshadri, Ph.D., M.B.A., as Senior Vice President, Head of Research & Clinical Development, effective June 1, 2021. Dr. Seshadri joins the company from Celgene Corporation, now a subsidiary of Bristol-Myers Squibb Company (BMS), and brings more than 20 years of experience including in academia and various senior and executive leadership roles in the life sciences industry overseeing product development, regulatory submissions, and commercialization for novel therapies including personalized, autologous cell therapies.
“I am very excited to announce Vish as our new Head of Research & Clinical Development,” said Michael Amoroso, Chief Executive Officer of Abeona. “Vish has significant experience in both biotech and pharma, working as a product lead with clinical teams across early- and late-stage development, from ‘first patient in’ all the way through successful commercial launches. He knows the trade-off decisions and discipline necessary for evidence-based drug development. Vish has also proven himself as a coach in developing people across functions through his project leadership with clinical, regulatory, and commercial teams at Celgene. Given his qualifications, we believe Vish will add significant value to Abeona and its development programs as we continue to advance toward several near-term milestones. He will be responsible for leading Abeona’s research and clinical programs, including all preclinical scientific efforts, and overseeing the company’s ongoing and future clinical trials and regulatory strategy. He will also oversee all research and clinical-stage business development activities.”
“In evaluating Abeona's pipeline therapies, I am impressed with their transformational potential for patients and the positive clinical data,” said Dr. Seshadri. “It is an exciting time to lead the clinical organization at Abeona with its lead product candidate, EB-101, advancing toward completing a pivotal study. In addition, we look forward to the Type B meeting with the FDA in June to discuss the data-to-date from the ABO-102 Transpher A study and the potential path to a Biologics License Application submission for ABO-102 in MPS IIIA.”
At Celgene (BMS), Dr. Seshadri served in roles of increasing responsibility focused on research & development and commercialization for novel therapies in hematology and oncology, most recently as Executive Director & Worldwide Brand Leader for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for relapsed or refractory large B-cell lymphoma. While at Celgene, he led franchise level marketing and the project management office for CAR T commercialization and led teams supporting the successful global launch of Breyanzi®. He also led development project teams for clinical development and regulatory submissions for REVLIMID® (lenalidomide) in lymphoma, strategic go/no-go decisions for Avadomide and IMFINZI® (durvalumab) while implementing program-wide efficiency measures, and managed post-marketing commitments for ISTODAX® (romidepsin). Previously, he was Head of Early-Stage Upstream Process Development for Biologics at Dr. Reddy's Laboratories, where he led cell-line development, current Good Manufacturing Practices (cGMP) cell banking, characterization, and cell culture optimization for biosimilars. Dr. Seshadri completed his Ph.D. in Microbiology, Immunology & Molecular Biology and his post-doc in epigenetics at University of Arizona, and earned his M.B.A. in Finance and Healthcare from the Wharton School of the University of Pennsylvania.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeona’s clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel AAV-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Company’s portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical needs. Abeona’s novel, next-generation AIM™ capsids have shown potential to improve tropism profiles for a variety of devastating diseases. Abeona’s fully functional, gene and cell therapy cGMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and commercial production of AAV-based gene therapies. For more information, visit www.abeonatherapeutics.com.
Forward-Looking Statements
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. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “estimate,” “expect,” 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, numerous risks and uncertainties, including but not limited to the potential impacts of the COVID-19 pandemic on our business, operations, and financial condition, continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the outcome of any future meetings with the U.S. Food and Drug Administration or other regulatory agencies, the impact of competition, 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, risks associated with data analysis and reporting, and other risks disclosed in the Company’s most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q and other periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
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