Grit Biotechnology Receives U.S. FDA Clearance of Investigational New Drug Application for GT201, a genetically engineered TIL, following its Chinese IND Approval

Grit Biotechnology, a leading clinical-stage cell therapy company focusing on tumor-infiltrating lymphocyte (TIL) therapies, has achieved a major milestone with its genetically engineered TIL product, GT201. Following its investigational new drug (IND) approval in China in July 2023, GT201 has now also received IND clearance from the U.S. FDA, paving the way for clinical trials in the United States.

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

Grit Biotechnology is a clinical stage cell therapy company leading TIL therapy development based in China. Core technology platforms supporting its TIL and other cell therapy development include StemTexp® (proprietary stemness TIL expansion platform), StaViral® (stable virus transduction system), KOReTIL® (efficient CRISPR KO system) and ImmuT Finder® (genome-wide CRISPR/Cas screening platform). These platforms have enabled the development of next-generation gene-edited TIL products and other cell therapies.

In addition, Grit’s non-gene-engineered TIL program, GT101, is currently in Phase 2 (pivotal) trials and is on track to file for Biologics License Application (BLA) in 2025, making it the leading TIL pipeline in China.

SOURCE Grit Biotechnology