Gamida Cell Ltd (GMDAQ)

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Gamida Cell Data Presented at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

https://finance.yahoo.com/news/gamida-cell-data-presented-2024-130000249.html

Expanded access program (EAP) data for omidubicel are consistent with Phase 3 trial results on rates of hematopoietic recovery and infections following stem cell transplant with Omisirge® (omidubicel-onlv)

Preliminary data presented on GDA-201, Gamida Cell’s natural killer (NK) cell therapy candidate in ongoing Phase 1 study for non-Hodgkin lymphoma, show promising early evidence of anti-tumor activity

BOSTON, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today presented data highlighting its expanded access program (EAP) for FDA-approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and Phase 1 data for its 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 take place February 21-24 virtually and in person in San Antonio, Texas.

“The data presented at Tandem provide further evidence of the potential of Gamida Cell’s nicotinamide (NAM) technology to develop potentially curative therapies by expanding and enhancing cells,” said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. “The EAP study provided the opportunity to treat patients after completion of enrollment of the Phase 3 trial and prior to the approval of Omisirge. It allowed for institutional variability in conditioning regimens and supportive care, more closely reflecting the real-world environment. Data were consistent with previous studies, showing that patients transplanted with omidubicel had rapid hematopoietic recovery and a low rate of serious infections post-transplant.”

“The Phase 1 data on our natural killer (NK) cell candidate GDA-201 further support the anti-tumor activity of our NAM-enhanced cellular therapy, and today marked the first presentation of study results using our cryopreserved, readily available formulation,” Simantov added.

Reporting on omidubicel’s EAP data, principal investigator Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer Institute, said, “I am highly encouraged by the results in the omidubicel expanded access program. The potential for rapid hematopoietic recovery post-transplant observed with omidubicel could make a meaningful impact on patient health. I am pleased to see that the EAP results are consistent with data from the Phase 3 study.”

Additional details on the 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. CT

Presentation highlights: In this expanded access program (EAP) 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 =12 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 (first grade 2-3 bacterial / invasive fungal infections at 100 days posttransplant: 18%), graft-versus-host-disease (grades 3-4: 19%), disease-free survival (79%) and overall survival (87%). Demographics of transplanted patients were 55% White, 21% Asian, 17% Black, and 7% other, consistent with the Phase 3 trial, in which >40% of the study participants were racially or ethnically diverse. 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. CT

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. Patients were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant. Patients were treated with doses up to 2x108 cells/kg GDA-201 in combination with rituximab. There were no infusion reactions, dose-limiting toxicities or related serious adverse events. 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 (grade 1 and grade 2, respectively). There were no cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease reported. Treatment and evaluation of patients in the fourth cohort of the study at the highest dose level of 2x108 cells/kg is ongoing. Full results are expected in Q1 2024.

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