Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.
In May 2020, we reported topline results from an international, multi-center, randomized Phase 3 clinical study in 125 patients demonstrating that omidubicel was generally well tolerated and the median time to neutrophil engraftment was significantly shorter for patients who were randomized to omidubicel than those in the comparator group. In October 2020, we reported that the study met all three of its secondary endpoints related to platelet engraftment, infections, and hospitalizations, which are key measures in bone marrow transplant. Full safety and efficacy data are anticipated in the fourth quarter of 2020. We also expect to initiate the submission of a biologics license application (BLA) filing, on a rolling basis, in the fourth quarter.
For more information about the topline study results, please see here.