Definition

An allogeneic, off-the-shelf, natural killer (NK) cell product derived from a clonal master induced pluripotent stem cell (iPSC) line, and engineered to express a high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, with potential antineoplastic and immunostimulatory activities. Upon administration, iPSC-derived CD16-expressing NK cells FT516 bind to the Fc portion of tumor cell-bound monoclonal antibodies and activate NK cell activation, cytokine secretion and antibody-dependent cellular cytotoxicity (ADCC). CD16, also known as Fc-gamma receptor III, is normally expressed on the surface of NK cells, neutrophils, monocytes and macrophages, and plays a key role in initiating ADCC. It is often downregulated in certain cancers, thereby inhibiting the anti-tumor immune response. FT516 NK cells’ hnCD16 Fc receptor prevents downregulation and optimizes binding to tumor-targeting antibodies for enhanced ADCC.