Gamida Cell is a clinical-stage biopharmaceutical company committed to developing advanced cell therapies with the potential to cure blood cancers and rare, serious hematologic diseases. We are leveraging our proprietary nicotinamide-based, or NAM-based, cell expansion technology to develop product candidates designed to address the limitations of cell therapies.
Our lead clinical candidate, omidubicel1, has the potential to serve as a life-saving allogeneic hematopoietic stem cell transplant solution for patients with high-risk blood cancers and bone marrow failure disorders. Omidubicel demonstrated rapid and durable time to engraftment in a Phase 1/2 clinical study sponsored by us.2 It is currently being evaluated in an international, multi-center Phase 3 study in patients with leukemia and lymphoma sponsored by us, as well as in a Phase 1/2 study in patients with severe aplastic anemia sponsored by the National Institutes of Health.
Beyond omidubicel, we are developing GDA-201, which is designed to harness the power of the anti-tumor properties found within natural killer (NK) cells. GDA-201 has the potential to serve as a universal donor-based therapy when combined with standard-of-care therapeutic antibodies. The GDA-201 program is currently being evaluated in an investigator-sponsored, Phase 1 study in patients with refractory non-Hodgkin lymphoma or multiple myeloma. Early data from the ongoing study demonstrated that GDA-201 was generally well tolerated, with encouraging signs of clinical activity in patients with advanced disease.3
1 Gamida Cell’s lead development candidate consists of omidubicel (expanded hematopoietic stem cells) and differentiated immune cells, including T cells. Gamida Cell refers to the two components collectively as “omidubicel.”
2 Phase I/II Study of Stem-Cell Transplantation Using a Single Cord Blood Unit Expanded Ex Vivo with Nicotinamide. Horwitz M.E., Wease S., Blackwell B., et al. Journal of Clinical Oncology. 2018 DOI: 10.1200/JCO.18.00053.
3 First-in-Human Phase I Study of Nicotinamide-Expanded Related Donor Natural Killer Cells for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma and Multiple Myeloma. Bachanova V. Presented at the 2019 TCT Meetings of ASBMT and CIBMTR.