Gamida Cell Ltd. shared new data on the impact of the company?s proprietary nicotinamide (NAM) technology on its allogeneic stem cell therapy omidubicel and investigational natural killer (NK) cell therapy candidate GDA-201 at the Society for Immunotherapy of Cancer?s (SITC) Annual Meeting in San Diego, CA. Both omidubicel and GDA-201 are powered by Gamida Cell?s proprietary NAM technology, which enhances and expands cells to create potentially curative cell therapies for patients with cancer. Omidubicel was approved under the brand name Omisirge?

(omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant; GDA-201 is in Phase 1 study for the treatment of non-Hodgkin lymphoma (NCT05296525). Data on the first three cohorts of the Phase 1 study of GDA-201 were recently reported. Significant myeloid and dendritic cellular enrichment of omidubicel graft suggests fast homeostatic proliferation of lymphoid populations.

Highlights: In this study, immunophenotyping was used to evaluate and characterize the cellular populations in the cultured fraction (CF) and non-cultured fraction (NF) of omidubicel (manufactured with Gamida Cell?s proprietary NAM technology) compared to standard umbilical cord blood (UCB). Manufacturing significantly increased the total nucleated cells (1.2-1.6-fold) and myeloid cells (2.2-3.6-fold) in the omidubicel CF compared to UCB. In addition, high resolution analysis of the CF showed a 25-62-fold increase in myeloid populations and dendritic cells and an absence of mature lymphoid cell populations.

The NF was found to contain 50-70% fewer total with a comparable percentage of T cells, B cells, NK cells and NK-T cells to UCB. The results of this phenotypic characterization of omidubicel provide a potential mechanism for the rapid engraftment and immune reconstitution observed in transplanted patients. Title: GDA-201, nicotinamide (NAM) expanded NK cells derived from peripheral apheresis, show unique culture kinetics and increased expansion.

Highlights: This study evaluated the impact of Gamida Cell?s NAM technology on NK cell kinetics. During the first days of expansion, NAM increased the survival of the feeder cells (45% on day 2-3 vs 13% on day 2-3) and prolonged their support in NK cell expansion, resulting in higher fold expansion persisting up to 21 days. In addition, NK cells expanded using NAM showed significantly higher cytotoxicity against leukemia cells (from a killing cytotoxicity function of 62.54% without NAM to 81.84% with NAM), and preservation of the NK cells in a partially mature state with low expression of CD57.

These data provide further evidence for the unique cell culture kinetics of NAM-NK cells, GDA-201, which is currently being evaluated in a Phase 1 clinical trial in patients with non-Hodgkin lymphoma.