GMDA - Gamida Cell to Present at the 2024 Tandem Meetings of ASTCT® and CIBMTR® | Benzinga
BOSTON, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced it will present new data on its FDA approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The hybrid meetings will take place virtually and in person at the Henry B. González Convention Center in San Antonio, Texas, February 21-24.
Additional details about the poster presentations are as follows:
Title: Omidubicel-onlv for Allogeneic Transplantation (allo-HCT) in Patients with Hematologic Malignancies: Results of a Multicenter Open-Label Expanded Access Program (EAP)
Abstract Number: 313
Lead Author: Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer Institute
Time: February 22, 6:45-7:45 p.m. ET
- Abstract highlights: An Expanded Access Program (EAP) evaluated outcomes in 29 patients with hematologic malignancies following allo-HCT with omidubicel. Eligible patients ?12 years of age received myeloablative conditioning, prophylactic medications and supportive care per individual institutional standards. Results demonstrated rapid hematopoietic recovery and low rate of infections. Safety and efficacy, including relapse, disease-free survival and overall survival, were similar to those observed in the Phase 3 study of omidubicel. Omidubicel was approved under the brand name Omisirge® (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant.
Title: A Phase I/II Study of GDA-201, Cryopreserved Nicotinamide-Enhanced Allogeneic Natural Killer Cells, in Patients with Relapsed/Refractory B-cell Lymphoma
Abstract Number: 255
Lead Author: Brian C. Shaffer, Associate Professor of Medicine and Head of the Adult Mismatched Donor Sub-Program at Memorial Sloan Kettering Cancer Center in New York
Date and Time: February 22, 6:45-7:45 p.m. ET
- Abstract highlights: This is an ongoing multicenter Phase 1 study of allogeneic cryopreserved NK cell therapy candidate GDA-201 in patients with relapsed/refractory B-cell CD20 positive non-Hodgkin lymphoma. Preliminary data for the 10 patients enrolled in the first three of four total cohorts, who were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant, showed no infusion reactions, dose limiting toxicities or related serious adverse events reported in patients treated with doses up to 1x108 cells/kg GDA-201 in combination with rituximab. Marked shrinkage of target lesions was observed in five patients and efficacy evaluation showed two patients with complete response, two with partial response and one with stable disease. Two patients treated had cytokine release syndrome. There were no reported cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease.
About GDA-201
GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024.
GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
Omisirge® (omidubicel-onlv) Indication
Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who ...