Grit Biotech's GT201 Secures U.S. FDA Clearance, Boosting Global Approval After China

Grit Biotechnology, a prominent player in clinical-stage cell therapy, has reached a significant achievement with its next-generation tumor-infiltrating lymphocyte (TIL) product, GT201. After securing investigational new drug (IND) approval in China in July 2023, GT201 has now also received IND clearance from the U.S. FDA, clearing the path for clinical trials in the United States. GT201, developed using Grit Biotechnology’s proprietary StemTexp® and StaViral® platforms, is a cutting-edge genetically engineered TIL therapy. 

It enhances T cell survival and function through the expression of a crucial membrane-bound cytokine complex. GT201 offers superior performance compared to conventional TIL therapies, including enhanced proliferation, tumor-killing ability, and prolonged survival, with less reliance on IL-2. With IND approvals from both the U.S. FDA and China’s Center for Drug Evaluation (CDE), GT201 is set to advance to clinical trials in both countries for patients with advanced solid tumors.

Grit Biotechnology, a trailblazer in clinical-stage cell therapy based in China, is at the forefront of developing tumor-infiltrating lymphocyte (TIL) therapies. The company’s cutting-edge platforms drive its progress in TIL and cell therapy innovations. These include StemTexp® for expanding stemness TILs, StaViral® for stable virus transduction, KOReTIL® for efficient CRISPR knockout, and ImmuT Finder® for comprehensive genome-wide CRISPR/Cas screening.

Leveraging these technologies, Grit Biotechnology has advanced the development of next-generation gene-edited TIL therapies and other cell treatments. Additionally, Grit's non-gene-edited TIL program, GT101, is currently in pivotal Phase 2 trials and is poised to apply for a Biologics License Application (BLA) in 2025, positioning it as the leading TIL pipeline in China.