Fate Therapeutics has opened its current Good Manufacturing Process (cGMP) compliant manufacturing facility for the clinical production of its off-the-shelf natural killer (NK) cell and chimeric antigen receptor (CAR) T-cell product candidates. The Company’s cGMP facility, located in San Diego, California, is custom designed for the manufacture of off-the-shelf allogeneic cell products using clonal master induced pluripotent stem cell (iPSC) lines as a starting cell source. The new facility has been commissioned and qualified, and the Company has been issued a drug manufacturing license by the State of California, Department of Health Services, Food and Drug Branch.
“The on-time launch of our cGMP manufacturing facility is a significant milestone that positions the Company as the leading manufacturer and developer of off-the-shelf NK cell and CAR-T cell cancer immunotherapies,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “With full control of cGMP production, combined with our proven ability to genetically-engineer induced pluripotent stem cells and create clonal master iPSC banks qualified for clinical use, we believe we have established operational capabilities unique to the industry to ensure consistent, large-scale, and cost-effective manufacture of best-in-class off-the-shelf cell products for on-demand delivery to patients.”
In early September, Fate Therapeutics announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application for FT596, its off-the-shelf, iPSC-derived CAR NK cell product candidate engineered to target multiple tumor-associated antigens, for the treatment of B-cell lymphoma and chronic lymphocytic leukemia. The Company is also conducting first-in-human clinical trials of FT516, an off-the-shelf, iPSC-derived NK cell product candidate engineered to express a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, for the treatment of acute myeloid leukemia and B-cell lymphoma, and FT500, an off-the-shelf, iPSC-derived NK cell product candidate, for the treatment of advanced solid tumors.