Gamida Cell Ltd. has announced that new data from its clinical programs will be presented at the 2019 Transplantation & Cellular Therapy (TCT) Meetings of American Society for Blood and Marrow Transplantation (ASBMT) and Center for International Blood and Marrow Transplant Research (CIBMTR) taking place in Houston, Texas, February 20 – 24.
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.
NiCord®, Gamida Cell’s lead clinical program, is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. NiCord® has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration, making it the first bone marrow transplant alternative to receive this designation. It has also received U.S. and EU orphan drug designation. A Phase 3 clinical study evaluating NiCord® in patients with leukemia and lymphoma is ongoing in the United States, Europe and Asia. NiCord® is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia. The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn®, which is the same investigational development candidate as NiCord®.
There will be two presentations on NiCord®, including an oral presentation describing translational data from the completed Phase 1/2 study of NiCord® in patients with high-risk hematologic malignancies, or blood cancers. Initial data from a Phase 1/2 study of NiCord® in patients with severe aplastic anemia will also be presented. Data from other programs will also be presented.
Abstracts are available on the 2019 TCT Meetings of ASBMT and CIBMTR website.
Time: Wednesday, February 20, 2019, 9:00 a.m. – 5:00 p.m. CT (poster displayed) and 6:45 p.m. – 7:45 p.m. CT (presentation)
Title: Ex Vivo Nicotinamide-Expanded (NAM-Expanded) Unrelated Cord Blood Transplantation (UCB) for Refractory Severe Aplastic Anemia Results in Rapid Engraftment and Expedites Immune Recovery
Poster Number: 295
Lead Author: Joseph Clara, M.D., Hematology Branch, National Heart, Lung, and Blood Institute
Location: George R. Brown Convention Center, Level 3, Hall B
Time: Saturday, February 23, 2019, 4:45 p.m. – 5:00 p.m. CT (oral presentation)
Title: Rapid and Robust CD4+ and CD8+ T-, NK-, B-Cell, Dendritic Cell, and Monocyte Reconstitution after Nicotinamide-Expanded Cord Blood Transplantation
Abstract Number: 69
Lead Author: Jaap-Jan Boelens, M.D., Ph.D., Chief, Pediatric Stem Cell Transplantation and Cellular Therapies Service, Memorial Sloan Kettering Cancer Center
Location: Hilton Americas Houston, Grand Ballroom G
“We are pleased with our continued progress with NiCord®, our late-stage development program in bone marrow transplantation, and we are encouraged by the clinical profile of NAM-NK that is emerging from this first Phase 1 clinical study.” … “Collectively, the data that will be presented next month reinforce our belief that our proprietary nicotinamide, or NAM, cell expansion technology has the potential to deliver transformative treatments to patients.” – Ronit Simantov, M.D., chief medical officer at Gamida Cell