No Morphologic Evidence of Leukemia and Complete Neutrophil Recovery Observed in First Patient Treated with FT516 Monotherapy for AML following First Dosing Cycle
No Dose-limiting Toxicities or FT500-related SAEs Reported in First 12 Patients Treated with FT500 for Advanced Solid Tumors
Favorable FT500 Phase 1 Safety, Tolerability and Immunogenicity Profile Validates Novel Multi-dose Treatment Paradigm for Off-the-shelf, iPSC-derived NK Cell Products
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced initial clinical data for its FT516 and FT500 off-the-shelf, iPSC-derived natural killer (NK) cell product candidates.
“The safety, tolerability, and immunogenicity data from the Phase 1 dose-escalation stage of FT500, the first-ever cell therapy derived from a clonal master induced pluripotent stem cell line to undergo clinical investigation in the U.S., provide compelling evidence that multiple doses of iPSC-derived NK cells can be delivered off-the-shelf and administered without patient matching,” said Wayne Chu, M.D., Vice President of Clinical Development of Fate Therapeutics. “Additionally, initial clinical observations with FT516 are very encouraging, as an assessment of the first AML patient’s bone marrow at Day 42 following three once-weekly doses of FT516 demonstrated anti-leukemia activity and hematopoietic recovery.”
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