Fate Therapeutics announces FDA clearance of IND application for FT596
Fate Therapeutic announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug application for FT596, the Company's first off-the-shelf chimeric antigen receptor natural killer cell cancer immunotherapy which targets multiple tumor-associated antigens. FT596 is derived from a clonal master induced pluripotent stem cell line engineered with three functional modalities designed to optimize anti-tumor activity: a proprietary CAR targeting B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 Fc receptor; and an interleukin-15 receptor fusion. The Company plans to initiate clinical investigation of FT596 as a monotherapy and in combination with CD20-directed monoclonal antibodies for the treatment of B-cell lymphoma and chronic lymphocytic leukemia. FT596, which is the first cellular immunotherapy engineered with three active anti-tumor components cleared for clinical investigation by the FDA, is uniquely designed to overcome CD19 antigen escape. In addition to a proprietary CAR targeting CD19, FT596 expresses a novel hnCD16 Fc receptor that has been modified to augment antibody-dependent cellular cytotoxicity, enabling coincident targeting of CD19 and additional antigens such as CD20. FT596 also expresses IL-15RF, a potent cytokine complex that promotes survival, proliferation and trans-activation of NK cells and CD8 T cells without the need for systemic cytokine support. Together, these features of FT596 are intended to maximize potency and minimize toxicity in treated patients. FT596 is the third off-the-shelf, iPSC-derived NK cell product candidate from the Company's proprietary iPSC product platform cleared for clinical investigation by the FDA in less than one year. The Company is conducting first-in-human clinical trials of FT516, an off-the-shelf NK cell cancer immunotherapy engineered to express hnCD16, for the treatment of acute myeloid leukemia and B-cell lymphoma, and FT500, an off-the-shelf NK cell cancer immunotherapy, for the treatment of advanced solid tumors.