Definition

A population of cryopreserved, off-the-shelf (OTS) allogeneic natural killer (NK) cells derived from human placental hematopoietic stem cells (HSCs) expressing the CD34 surface antigen, and engineered to express a high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, with potential antineoplastic and immunostimulatory activities. Upon infusion of CYNK-101, the allogeneic CD16-expressing NK cells bind to the Fc portion of tumor cell-bound monoclonal antibodies that were administered as induction therapy. This enhances NK cell activation, cytokine secretion, and antibody-dependent cellular cytotoxicity (ADCC) in the presence of certain antibody therapeutics. 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. CYNK-101 NK cells’ hnCD16 Fc receptor prevents downregulation and optimizes binding to tumor-targeting antibodies for enhanced ADCC.