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HER2-CAR-ipsNKT cells is an investigational, off-the-shelf, allogeneic chimeric antigen receptor (CAR) invariant natural killer T (iNKT) cell therapy derived from induced pluripotent stem cells (iPSCs). Developed by BrightPath Biotherapeutics in collaboration with RIKEN and Chiba University, the therapy is engineered to express a CAR targeting human epidermal growth factor receptor 2 (HER2). By utilizing iPSC-derived iNKT cells as a cellular backbone, the therapy aims to overcome manufacturing limitations associated with the low abundance of native iNKT cells in peripheral blood. HER2-CAR-ipsNKT cells exert direct cytotoxicity against HER2-positive tumor cells and promote a robust, indirect anti-tumor immune response by releasing cytokines (such as IFN-gamma, TNF-alpha, and IL-4), inducing dendritic cell maturation, promoting M1 macrophage polarization, and activating host endogenous tumor-specific cytotoxic T lymphocytes (CTLs) within the tumor microenvironment.
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