Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that Ronit Simantov, M.D. will join the Company as its new Chief Medical Officer (CMO) based in the U.S.
"We are delighted to welcome Dr. Simantov to Gamida Cell. We are now enrolling patients to the Phase 3 registration study of our FDA Breakthrough Designation product, NiCord®. Dr. Simantov will play a central role in the late stage development program and associated activities geared towards commercialization of NiCord, backed by the recently announced $40 million financing," said Gamida Cell president and CEO Yael Margolin, PhD.
Gamida Cell Chairman of the Board Julian Adams, PhD said, "We are certain that Dr. Simantov's background and experience in the industry will be a valuable addition to Gamida Cell. This is also the first step we are taking towards establishing a U.S. executive presence and transitioning Gamida Cell into a global commercial organization."
"Gamida Cell has an innovative pipeline of cellular and immune therapies with the potential to address significant patient needs in cancer and hematologic disease," said Dr. Simantov. "I look forward to leading the clinical development and regulatory path to approval of NiCord, a novel graft modality for patients undergoing bone marrow transplantation."
Dr. Simantov brings more than 20 years of experience in research, development, registration, and launch of hematology and oncology drugs. Prior to joining Gamida Cell, Dr. Simantov was Vice President and Head of Global Medical Affairs at Pfizer Oncology. Previous roles included Vice President, Head of Clinical Development at OSI Pharmaceuticals, Chief Medical Officer at CuraGen Corporation, and Global Clinical Leader in Oncology at Bayer HealthCare Pharmaceuticals. Dr. Simantov holds a B.A. from Johns Hopkins University in Baltimore, Maryland, and received her MD from New York University School of Medicine. She completed a residency in Internal Medicine and a Fellowship in Hematology and Oncology at New York-Presbyterian Hospital/Weill Cornell Medical College, where she served on the academic faculty for seven years before joining the pharmaceutical industry. Dr. Simantov has co-authored more than 40 peer-reviewed journal manuscripts.
About NiCord
NiCord is a stand-alone graft derived from a single umbilical cord blood unit which has been expanded in culture and enriched with stem and progenitor cells using Gamida Cell's proprietary NAM technology. NiCord leverages the advantages of umbilical cord blood, which does not need full tissue matching to the patient and can therefore be available to practically all patients in need. It also aims to address the major barrier of umbilical cord blood transplantation - delayed hematopoietic recovery - by demonstrating an advantage with a primary endpoint that is clinically meaningful.
Results from the Phase 1 and Phase 2 studies of NiCord were published in the April 2017 edition of the Journal of Biology of Blood and Marrow Transplantation (BBMT, the official publication of the American Society for Blood and Marrow Transplantation) entitled "Transplantation of Ex Vivo Expanded Umbilical Cord Blood (NiCord) Decreases Early Infection and Hospitalization".
Gamida Cell is currently enrolling patients in an international, multi-center, Phase 3 registration study of NiCord as a graft for bone marrow transplantation for patients with blood cancer who do not have a rapidly available fully matched donor. The Company announced in February 2017 that the first patient in the study had been transplanted. NiCord has an FDA Breakthrough Therapy Designation as well asFDA and EMA orphan drug designations, the most recent granted in March 2017. For more information on enrolling transplantation centers and study inclusion and exclusion criteria please click here.
About Gamida Cell Gamida Cell is a world leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases. The company's pipeline of products are in development to treat a wide range of conditions including cancer, genetic hematological diseases such as sickle cell disease and thalassemia, bone marrow failure syndromes such as aplastic anemia, genetic metabolic diseases and refractory autoimmune diseases. Gamida Cell's shareholders include Novartis, Clal Biotechnology Industries, Elbit Imaging, Israel Healthcare Ventures, Shavit Capital Fund, VMS Investment Group, Denali Ventures, Auriga Ventures and Israel Biotech Fund. For more information please visit www.gamida-cell.com.
