Gamida Cell: NiCord recipients showed immune reconstitution in study

Gamida Cell reported translational data showing that recipients who received NiCord, an investigational cell therapy in Phase 3 clinical development for allogeneic hematopoietic stem cell transplant had rapid and robust reconstitution of key immune cells. Successful immune reconstitution is an important factor in the recovery of patients undergoing bone marrow transplant. Despite the curative potential of bone marrow transplants, it is estimated that more than 40% of eligible patients in the U.S. do not receive one for various reasons, including finding a matched donor. While umbilical cord blood provides a source of stem cells for patients who do not have a matched related donor, it provides a smaller number of stem cells, which can delay engraftment and put patients at a greater risk for prolonged hospitalizations and life-threatening infections. NiCord is designed to address these limitations by offering a therapeutic dose of expanded cells while preserving the functional characteristics of stem cells. The poster presentation, “Rapid and robust CD4+ and CD8+ T-, NK-, B- and monocyte cell reconstitution after nicotinamide-expanded cord blood transplantation”, described early, in-depth immune reconstitution data from the completed Phase 1/2, multicenter clinical study of NiCord as a stand-alone graft after myeloablative therapy in patients with high-risk hematologic malignancies. A random subgroup of 27 patients from this study had extensive immune monitoring evaluated throughout the first year after transplant. The primary endpoint was the probability of achieving CD4+ immune reconstitution within the first 100 days, and the secondary endpoints included the recovery of B cells, CD4+ T cells and natural killer cells during the first year after transplantation. These data were compared to cohorts of adolescent and young adults with hematologic malignancies receiving unmanipulated cord blood transplantation or unrelated bone marrow transplantation. Key findings from the analysis include the following: 91% of patients achieved successful immune reconstitution of CD4+ T cells at 100 days after transplantation with NiCord. Immune reconstitution of T cells was similar in the NiCord group compared to the younger cohorts receiving unmanipulated cord blood and unrelated bone marrow. Immune reconstitution of B cells and NK cells was significantly faster after transplantation with NiCord compared to the other groups. Immune reconstitution after NiCord transplantation was associated with recovery of a broad spectrum of T cell, B cell and NK cell subsets representing a range of effector functions similar to that observed with other graft sources.

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