Fate Therapeutics (NASDAQ: FATE) presented initial clinical and preclinical data for FT825/ONO-8250, a CAR T-cell therapy targeting HER2 in advanced solid tumors. The Phase 1 study's first low-dose cohort of three heavily pre-treated patients showed favorable safety outcomes with no dose-limiting toxicities or adverse events. The therapy demonstrated CAR T-cell expansion and maintained activation state at Day 8 post-treatment.
The product incorporates a novel H2CasMab-2 binding domain designed to overcome on-target, off-tumor toxicity. Preclinical data showed selective targeting of cancer cells while limiting effects on normal HER2+ cells. The study continues enrollment at higher doses and in combination with EGFR-targeted antibody therapy.