Gamida Cell data presented at 2024 Tandem Meetings of ASTCT, CIBMTR

Gamida Cell presented data highlighting its expanded access program, EAP, for FDA-approved allogeneic stem cell therapy Omisirge and Phase 1 data for its allogeneic cryopreserved natural killer cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy, ASTCT, and the Center for International Blood and Marrow Transplant Research, CIBMTR. Title: Omidubicel-onlv for Allogeneic Transplantation in Patients with Hematologic Malignancies: Results of a Multicenter Open-Label Expanded Access Program: Presentation highlights: In this expanded access program evaluating outcomes in 29 patients with hematologic malignancies following allogeneic hematopoietic stem cell transplant with omidubicel, outcomes were overall consistent with those from omidubicel’s Phase 3 study. Eligible patients greater than or equal to12 years of age received myeloablative conditioning, prophylactic medications and supportive care per individual institutional standards. Median time to neutrophil and platelet engraftment were 12 and 34 days, respectively. Results were also similar to the Phase 3 study for infection, graft-versus-host-disease, disease-free survival and overall survival. Demographics of transplanted patients were 55% White, 21% Asian, 17% Black, and 7% other, consistent with the Phase 3 trial, in which greater than40% of the study participants were racially or ethnically diverse. Title: A Phase I/II Study of GDA-201, Cryopreserved Nicotinamide-Enhanced Allogeneic Natural Killer Cells, in Patients with Relapsed/Refractory B-cell Lymphoma: Presentation highlights: In this 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 first 12 patients were presented. Seven patients exhibited a decrease in tumor burden. Efficacy evaluation using Lugano criteria showed three patients with complete response, two with partial response and two with stable disease. Cytokine release syndrome was reported in two patients. There were no cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease reported. Full results are expected in Q1 2024.