FT516 is an off-the-shelf NK cell product candidate created from a clonal master iPSC line engineered with a high-affinity, non-cleavable CD16 (hnCD16) Fc receptor. Our novel hnCD16 Fc receptor has been modified to augment its binding affinity to monoclonal antibodies and to prevent the receptor’s shedding from the surface of NK cells upon activation, which can otherwise diminish the cells’ anti-tumor activity.
Engineered high-Affinity non-Cleavable CD16 Fc Receptor
In preclinical studies, we have shown that our FT516 cell therapy product candidate exhibits potent and persistent anti-tumor activity in multiple tumor cell recognition and killing assays:
- FT516 cells augment anti-tumor activity in combination with trastuzumab (brand name Herceptin) in vivo, as compared to mice treated with trastuzumab alone, in a HER2+ ovarian cancer model;
- FT516 cells exhibit superior ADCC when combined with cetuximab (brand name Erbitux), as compared to conventional NK cells sourced from peripheral blood and cord blood, in an in vitro killing assay of a human ovarian cancer cell line; and
- FT516 cells show a dose-dependent killing response in combination with rituximab (brand name Rituxan) in vitro in a CD20+ human lymphoblast-derived B-lymphocyte cell line killing assay.