Grit Biotechnology's TIL Therapy GT201 Cleared for US Trial in Advanced Solid Tumors

Grit Biotechnology received FDA clearance for GT201, a genetically-engineered TIL therapy for advanced solid tumors, based on StemTexp and StaViral platforms. GT201, which enhances T-cell survival and function without heavy reliance on IL-2, previously received IND clearance from China's Center for Drug Evaluation. Early data presented at ASGCT and ASCO 2023 showed stable in-vivo expansion and good safety profile. Grit is also developing GT101, a non-genetically engineered TIL product, on track for a China BLA submission in 2025.