Gamida Cell Ltd.Gamida Cell Ltd. (NASDAQ:GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, presented clinical updates on omidubicel in two presentations on the first day of the 63rd American Society of Hematology (ASH) Annual Meeting being held in Atlanta, Georgia and virtually December 11-14, 2021.
In an oral presentation titled “Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Robust Immune Reconstitution and Lower Rates of Severe Infection Compared to Standard Umbilical Cord Blood Transplantation,” Gamida Cell shared data from an analysis of a subset of 37 patients from the Phase 3 randomized trial of omidubicel. The analysis was aimed at investigating the reduced infection rates observed in the study and showed that the omidubicel-treated patients had more rapid recovery of a wide variety of immune cells including CD4+ T cells, B cells, NK cells and dendritic cell subtypes. The robust recovery of the immune system provides rationale for fewer severe bacterial, fungal and viral infections in patients treated with omidubicel. Further analyses are ongoing to further characterize the immune recovery following omidubicel transplantation.
“These results demonstrating rapid and functional reconstitution of the immune cells – particularly the T cell recovery which is known to lag in cord blood transplants – provides mechanistic support for the lower rates of severe infection observed in the omidubicel-treated patients,” said Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh. “These data provide encouraging support for patients suffering from blood cancers who are particularly vulnerable to devastating infections following transplant.”
An additional poster presentation unveiled today, “Allogeneic Stem Cell Transplantation with Omidubicel: Long-Term Follow-up from a Single Center,” includes outcomes of 22 patients in the Phase 1 and 2 studies of omidubicel at Duke University over a 10-year period and shows long-term sustained bone marrow function and immune recovery. With a median follow-up of 2.3 years the estimated 10-year overall survival (OS) is 48.5% and disease-free survival (DFS) is 43.6%, with no major and or unexpected long-term complications. Durable hematopoiesis was observed at up to 10 years with one case of secondary graft failure and no secondary malignancies.
“Following our positive Phase 3 study results that showed enhanced hematopoietic recovery with omidubicel, it is extremely encouraging to see these additional data that demonstrate the durability of the graft, providing long-term recovery of the hematopoietic system,” said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. “The analyses presented at ASH build on our understanding of the clinical benefits of omidubicel and provide compelling evidence of its potential to change the outlook for a patient population in dire need of enhanced treatment options.”
Gamida Cell will present additional clinical updates at ASH including two-year survival data for GDA-201, the company’s lead NAM-enabled NK cell therapy, and an analysis of hospital and healthcare resource use for patients treated with omidubicel compared to cord blood transplantation. Both poster presentations will be publicly available on Monday, Dec. 13.