Gamida Cell Ltd. (Nasdaq:GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, received a positive meeting correspondence from the U.S. Food and Drug Administration (FDA). The company plans to initiate a rolling Biologics License Application (BLA) submission for Omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. Gamida‘s aim with Omidubicel—an allogeneic, off-the-shelf, hematopoietic stem cell therapy—is to reduce the time to neutrophil engraftment, which results in patients being able to make healthy new cells.
As previously disclosed in late 2021, the FDA requested a revised analysis of the manufacturing data generated at Gamida’s wholly-owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced Omidubicel for the Phase 3 study. Gamida and the FDA have now reached alignment that analytical comparability has been established between the commercial manufacturing facility and the product that was manufactured for the Phase 3 study. Based on the demonstration of comparability, along with positive clinical results of the Phase 3 study, the FDA has agreed that the initiation of a rolling BLA submission is appropriate. Additional clinical data will not be required to initiate the BLA submission.
“We are very pleased that our productive interactions with the FDA have resulted in alignment on the Omidubicel manufacturing comparability analysis and agreement to initiate a rolling submission of our BLA application,” said Julian Adams, Ph.D., Chief Executive Officer of Gamida. “Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the FDA and has the potential to be the first FDA-approved advanced cell therapy for allogeneic bone marrow transplant. Initiating the BLA submission will move us one step closer toward bringing potentially curative therapies to patients. We plan to complete the full BLA submission in the first half of this year, which will be an important achievement for Gamida and the bone marrow transplant community.”
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with blood cancers. Omidubicel is the first bone marrow transplant graft to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S and EU. For more information about Omidubicel please visit https://www.gamida-cell.com.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
Gamida is pioneering a diverse immunotherapy pipeline of potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of Nikotinamide (NAM) to allogenic cell sources including umbilical cord blood-derived cells and natural killer (NK) cells to create therapies with the potential to redefine standards of care. These include Omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solidid tumors and hematological malignancies. For additional information, please visit www.gamida-cell.com or follow
Gamida Cell on Linkedin, Twitter, Facebook, or Instagram at @GamidaCellTx.
Courtney Turiano, Stern Investor Relations, Inc. courtney.turiano AT sternir.com
Source: Gamida https://www.gamida-cell.com/
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