We are preclinically developing FT825, a multiplexed-engineered, iPSC-derived, CAR T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2)-expressing solid tumors, under our collaboration with Ono Pharmaceutical.  HER2, also known as Human Epidermal Growth Factor Receptor 2, is a receptor tyrosine kinase that is overexpressed on many solid tumors, such as breast, gastric, bladder, and lung cancers.

FT825 incorporates seven novel synthetic controls of cell function.  In preclinical studies, the product candidate’s HER2 binding domain showed a highly selective and differentiated targeting profile including in comparison to other HER2-directed agents, exhibited robust dose-dependent cytolytic activity against both HER2-high and HER2-low cell lines from multiple tumor types, demonstrated limited activity against HER2-expressing cell lines from healthy tissue, and exhibited enhanced trafficking and migration properties in vitro and in vivo.  In addition to its CAR-mediated anti-tumor activity against HER2, co-activation of the product candidate’s HER2-targeted CAR and hnCD16 Fc receptor through combination with mAb therapy showed enhanced anti-tumor activity in preclinical models.

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