SAN FRANCISCO, June 26, 2024 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for disorders of the nervous system, today announced the appointment of Nadia Agopyan, Ph.D., RAC, as Senior Vice President of Regulatory Affairs.
“We are thrilled to have Nadia join Neurona as a strong addition to our senior leadership team,” said Cory R. Nicholas, Ph.D., the Co-Founder and Chief Executive Officer of Neurona. “With more than 20 years of industry experience in leading global regulatory strategy for drugs and biologics, including cell therapy, Nadia‘s expertise will help the company to progress our growing development pipeline of regenerative neural cell therapies.”
“I’m pleased to be joining Neurona, particularly in light of the FDA’s recent decision to award NRTX-1001 its RMAT designation, and the highly positive data coming out of the ongoing Phase 1/2 trial Neurona is conducting in drug-resistant temporal lobe epilepsy,” said Nadia Agopyan, Senior Vice President of Regulatory Affairs at Neurona Therapeutics. “There is a high unmet medical need in refractory focal epilepsy, and NRTX-1001 potentially represents a breakthrough, with the goal to provide persistent seizure control from a single administration.”
Nadia joins Neurona from Marker Therapeutics, where she served as Senior Vice President of Regulatory Affairs, helping to develop T cell therapies for solid tumors and hematological malignancies. Before that, she served as Director of Regulatory Affairs at Kite Pharma, Inc., now a subsidiary of Gilead Sciences. In this role, she was responsible for leading global regulatory development of the YESCARTA® franchise, a CAR T cell therapy for the treatment of relapsed or refractory non-Hodgkin’s lymphomas. Nadia also led the approval and launch efforts for Vonvendi, the first recombinant von Willebrand factor developed by Baxter for the treatment of von Willebrand Disease, and for Zytiga, the first oral, once-daily medication developed by Cougar Biotechnology a subsidiary of Johnson & Johnson for the treatment of metastatic castration-resistant prostate cancer. Nadia also oversaw clinical programs through Phase 1-4 development, as well as all operational aspects of a number of global regulatory submissions in several other companies.
Earlier in her career, Nadia worked as an Assistant Professor in neurophysiology at Duke University and University of Toronto, investigating the electrophysiological properties of neural structures in CNS diseases, including epilepsy. She earned her B.Sc. in Physiology and Ph.D. in Neurophysiology from McGill University in Montreal, Canada.
About FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation
Managed by the FDA’s Center for Biologics, Evaluation and Research (CBER), the RMAT program is dedicated to advancing investigational regenerative medicines, including cell therapies, that are intended to treat, modify, reverse, or cure serious diseases where preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs. Investigational therapies that receive RMAT designation are eligible to receive expedited development review and planning guidance from senior CBER managers. RMAT also creates a pathway for early discussions about potential surrogate endpoints and ways to support accelerated approval. The NRTX-1001 RMAT designation follows a positive data update from the ongoing Phase 1/2 clinical trial of NRTX-1001 cell therapy, demonstrating a favorable safety profile to date and the potential to significantly reduce seizure frequency in drug-resistant epilepsy.
About Neurona Therapeutics
Neurona is developing allogeneic, off-the-shelf, regenerative neural cell therapy products with curative potential to provide long-term repair of the nervous system after a single administration. The company’s lead product NRTX-1001, comprising GABAergic interneurons, is currently being studied for safety and efficacy in two ongoing open label multicenter Phase 1/2 trials (NCT05135091) for drug-resistant unilateral mesial temporal lobe epilepsy and (NCT06422923) for drug-resistant bilateral mesial temporal lobe epilepsy, with neocortical focal epilepsy and other indications planned in the future. The FDA granted the RMAT designation to NRTX-1001 in June 2024. A positive clinical update from the Phase 1/2 trial in unilateral TLE was presented at the American Academy of Neurology Annual Meeting in April 2024. In February 2024, Neurona raised $120 million in a private financing co-led by Viking Global Investors and Cormorant Asset Management. For more information about Neurona, visit: www.neuronatherapeutics.com.
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