IND enabling development of FT516: A Natural Killer Cell Immunotherapy for Cancer Derived from a Human Inducible Pluripotent Stem Cell

FT516 is a universal, off-the-shelf, targeted NK cell product candidate derived from a clonal master iPSC line engineered to express a novel high-affinity, non-cleavable variant of CD16 (hnCD16) that enhances its binding to therapeutic antibodies and prevents its down-regulation. A publication in December 2019 by scientists from the Company, the University of Minnesota, and the University of California, San Diego in the journal Blood (https://doi.org/10.1182/blood.2019000621), entitled “Pluripotent stem cell-derived NK cells with high-affinity non-cleavable CD16a mediate improved anti-tumor activity,” highlights preclinical proof-of-concept data for FT516. CIRM-funded IND-enabling work resulted in the successful filing of an IND for FT516 for use in blood cancers. We continue to conduct the dose-escalation stage of the FT516 Phase 1 clinical trial as a monotherapy for acute myeloid leukemia and in combination with rituximab for advanced B-cell lymphoma. In addition, we successfully expanded the clinical scope of our FT516 program to advanced solid tumors as part of our partnership with CIRM. In January of 2020, the FDA allowed our second IND application for FT516, enabling clinical investigation in combination with PDL1-, PD1-, EGFR- and HER2-targeting monoclonal antibody therapies across a broad range of solid tumors. We intend to initially evaluate FT516 in combination with avelumab, an ADCC-competent, anti-PDL1 immune checkpoint inhibitor, in patients with advanced solid tumors who are refractory to, or have relapsed following, at least one line of anti-PDL1 therapy and the clinical trial is scheduled to begin shortly.