Two presentations on omidubicel (formerly known as NiCord®), an investigational advanced cell therapy in Phase 3 clinical development designed to enhance the life-saving benefits of hematopoietic stem cell (bone marrow) transplant, developed by Gamida Cell Ltd., a leading cellular and immune therapeutics company, took place at the International Society for Cell and Gene Therapy (ISCT) 2019 Annual Meeting held in Melbourne, Australia.
Gamida Cell, founded in 1998, headquartered in Boston, Massachusetts, USA, with an office in Jerusalem, Israel, is a clinical stage biopharmaceutical company leveraging its proprietary technology to develop cell therapies that are designed to cure cancer and rare, serious hematologic diseases. Using its nicotinamide-, or NAM-, based cell expansion technology, the company is developing a pipeline of products designed to address the limitations of cell therapies.
The presentations included a summary of clinical and translational data from the completed Phase 1/2 clinical study of omidubicel in patients with high-risk hematologic malignancies, or blood cancers. Results from the Phase 1/2 study showed that patients transplanted with omidubicel had rapid and durable engraftment of neutrophils and platelets, as well as prompt immune reconstitution. An international, randomized Phase 3 study of omidubicel in patients with hematologic malignancies is currently ongoing.
Despite the curative potential of bone marrow transplants, it is estimated that more than 40 percent of eligible patients in the U.S. do not receive one for various reasons, including finding a matched donor. Even for patients who do receive a transplant, treatment is not always effective and can lead to serious complications that can dramatically affect quality of life. Omidubicel is intended to address the current limitations of bone marrow transplant by providing a therapeutic dose of cells while preserving the cells’ functional therapeutic characteristics.
“In the Phase 1/2 clinical study, patients who received omidubicel had a clinically meaningful reduction in their time to neutrophil and platelet recovery compared to a real-world cohort of patients who received a standard umbilical cord blood transplant. The neutrophil recovery observed with omidubicel also resulted in fewer days spent in the hospital compared to the comparator cohort.” … “These data suggest an important potential step toward making stem cell transplantation safer and more accessible to patients with lethal blood cancers, and I am pleased to be participating in the Phase 3 study currently enrolling patients.” – Joanne Kurtzberg, M.D., Director of the Marcus Center for Cellular Cures and the Carolinas Cord Blood Bank, Duke University Medical Center
“At Gamida Cell, our aspiration is to bring the first FDA-approved cell therapy for bone marrow transplantation to patients.” … “These data demonstrate the potential of omidubicel to give patients with high-risk blood cancers, particularly those who would not otherwise receive a bone marrow transplant from a matched donor, an opportunity for a cure.” – Ronit Simantov, M.D., chief medical officer, Gamida Cell