Fate Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for FT536, an off-the-shelf, multiplexed-engineered, iPSC-derived, chimeric antigen receptor (CAR) NK cell product candidate. FT536 is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with four functional elements, including a novel CAR that uniquely targets the a3 domain of the major histocompatibility complex (MHC) class I related proteins A (MICA) and B (MICB). MICA and MICB are stress proteins that are expressed at high levels on many solid tumors.

The Company plans to initiate clinical investigation of FT536 as a monotherapy and in combination with tumor-targeting monoclonal antibody therapy for the treatment of multiple solid tumor indications. FT536 also incorporates a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; an IL-15 receptor fusion (IL-15RF) that augments NK cell activity; and the deletion of the CD38 gene (CD38KO), which promotes persistence and function in high oxidative stress environments such as the suppressive tumor microenvironment. The multi-center Phase 1 clinical trial of FT536 is designed to determine the maximum tolerated dose of FT536 and assess its safety and clinical activity as monotherapy and in combination with one of an array of five monoclonal antibodies for the treatment of advanced solid tumors.

Eligible tumor types include advanced non-small cell lung cancer, colorectal cancer, head and neck cancer, gastric cancer, breast cancer, ovarian cancer, and pancreatic cancer. The Phase 1 clinical protocol allows for administration of FT536 initially in up to two, 30-day cycles, with each cycle consisting of three days of conditioning chemotherapy and three weekly doses of FT536. Patients with clinical benefit may be re-treated with up to two additional cycles.

Furthermore, for those patients that achieve initial clinical response, additional treatment with FT536 may be administered following disease progression. The off-the-shelf treatment regimen is designed to be administered in the outpatient setting.