The FDA has signed off on Fate Therapeutics’ (FATE +3.7%) IND for FT596, an off-the-shelf chimeric antigen receptor (CAR) natural killer (NK) cell cancer immunotherapy that targets a range of tumor-associated antigens.
First up is a clinical trial evaluating FT596, as monotherapy and in combination with CD20-directed monoclonal antibodies, for the treatment of B-cell lymphoma and chronic lymphocytic leukemia.
CEO Scott Wolchko says, “FT596 is a ground-breaking product candidate with the potential to supplant current-generation patient-specific and allogeneic CAR19 T-cell immunotherapies, which recognize only one antigen and fail to address the significant risk of relapse due to antigen escape. Our robust clinical development strategy for FT596 is designed to target multiple tumor-associated antigens for the treatment of B-cell lymphomas and leukemias. We believe the product candidate’s engineered functionality, coupled with its ability to be cost-effectively administered on-demand in multiple treatment cycles, will deliver a deeper and more durable response to patients compared to single-antigen targeted CAR19 T cells.”
FT596 is derived from a clonal master induced pluripotent stem cell (iPSC) 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 (hnCD16) Fc receptor; and an interleukin-15 receptor fusion (IL-15RF).
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