Neurona Therapeutics Appoints Dr. Nadia Agopyan as Senior Vice President of Regulatory Affairs
27 June 2024 - 6:05AM
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.
Media Contact:
Elizabeth Wolffe, Ph.D.Wheelhouse
LSAlwolffe@wheelhouselsa.com
Investor Contact:Laurence WattsNew Street
Investor Relationslaurence@newstreetir.com