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FT516 is an investigational, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master human induced pluripotent stem cell (iPSC) line. The cells are genetically engineered to express a high-affinity, non-cleavable variant of the CD16a (FcgammaRIIIa) receptor, which enhances their ability to mediate antibody-dependent cellular cytotoxicity (ADCC). This modification prevents down-regulation by the metalloprotease ADAM17 and maximizes binding to tumor-targeting antibodies. The product is designed for use as monotherapy or in combination with approved monoclonal antibodies that rely on ADCC for anti-tumor activity. Developed as a universal, mass-producible therapy, FT516 aims to provide immediate patient access and multi-dose administration for advanced cancers[2][3][4][5][6][8].
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