Fate Therapeutics Announces Clinical Data from Landmark Phase 1 Studies of First-ever Universal, Off-the-shelf, iPSC-derived NK Cell Cancer Immunotherapy Programs

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

SAN DIEGO, Dec. 07, 2019 (GLOBE NEWSWIRE) -- 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.”

FT516 Universal, Off-the-shelf, Engineered iPSC-derived NK Cell Product Candidate
The FT516 study is an open-label, multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia (AML) and in combination with CD20-directed monoclonal antibodies for the treatment of advanced B-cell lymphoma, and is the first-ever clinical investigation of a cell product derived from a clonal master engineered induced pluripotent stem cell (iPSC) line. Two patients, both heavily pretreated, have been treated with FT516 to date, and the first clinical findings include:

• FT516 First AML Patient. The first patient enrolled for the treatment of AML was refractory to initial 7+3 induction therapy, multiple subsequent re-induction attempts with chemotherapy, and a combination therapy of venetoclax plus decitabine. Following outpatient lympho-conditioning, the patient received a first cycle of three once-weekly doses of FT516 (90 million cells per dose) as a monotherapy and IL-2 cytokine support. A bone marrow biopsy obtained at Day 42 following the completion of the first FT516 treatment cycle showed no morphologic evidence of leukemia and evidence of hematopoietic recovery. Concurrently, no circulating leukemia cells were observed in the peripheral blood, and the patient showed neutrophil recovery without growth factor support (>1,000 per µL). In addition, no dose-limiting toxicities (DLTs), Grade ≥3 adverse events (AEs) or serious adverse events (SAEs) related to FT516 were reported. The patient is expected to receive a second FT516 treatment cycle of three once-weekly doses of FT516. A formal response assessment will be performed following completion of this second FT516 treatment cycle.
• FT516 First Lymphoma Patient. Prior to treatment with FT516, the first patient enrolled with high-risk diffuse large B-cell lymphoma (DLBCL) having relapsed after multiple rituximab combination regimens, autologous hematopoietic stem cell transplant, and chimeric antigen receptor (CAR) T-cell therapy. Following outpatient lympho-conditioning, the patient received a first cycle of three once-weekly doses of FT516 (30 million cells per dose) in combination with rituximab and IL-2 cytokine support. A second treatment cycle of three once-weekly doses of FT516 in combination with rituximab has been initiated. A formal response assessment will be performed following completion of this second FT516 treatment cycle.

FT500 Universal, Off-the-shelf, iPSC-derived NK Cell Product Candidate