China-based clinical-stage cell therapy company focusing on tumour-infiltrating lymphocyte (TIL) therapies Grit Biotechnology announced on Friday that it has received investigational new drug (IND) approval from the US FDA for clinical trials of GT201 in the United States.

This move follows GT201's IND approval in China in July 2023.

GT201, an advanced genetically engineered TIL product developed by Grit Biotechnology's platform StemTexp and StaViral, is claimed to boost T cell survival and function by expressing a vital membrane-bound cytokine complex. Grit Biotechnology adds that GT201 surpasses traditional TIL therapies in proliferation, tumour-killing efficacy and long-term survival with reduced dependence on IL-2. Now, GT201 IND is approved by both US FDA and China Center for Drug Evaluation (CDE) to enter clinical trials in both countries for advanced solid tumour patients.

Currently, the company's non-gene-engineered TIL program, GT101, is in phase two (pivotal) trials and is on track to file for Biologics License Application (BLA) in 2025.