Grit Biotechnology Gets U.S. FDA Clearance for GT201 After Chinese IND Approval

SHANGHAI, Aug. 30, 2024 -- Grit Biotechnology, a prominent clinical-stage cell therapy company specializing in tumor-infiltrating lymphocyte (TIL) therapies, has accomplished a significant milestone with its advanced genetically engineered TIL product, GT201. This achievement comes after GT201 received investigational new drug (IND) approval in China in July 2023 and has now secured IND clearance from the U.S. FDA, setting the stage for clinical trials in the United States.

Developed through Grit Biotechnology's innovative platforms, StemTexp® and StaViral®, GT201 stands out as an advanced genetically engineered TIL product. It enhances T cell survival and function by expressing an essential membrane-bound cytokine complex. GT201 outperforms traditional TIL therapies by demonstrating superior proliferation, tumor-killing efficacy, and long-term survival, while also showing a reduced reliance on IL-2. With IND approvals from both the U.S. FDA and the China Center for Drug Evaluation (CDE), GT201 is set to enter clinical trials in both countries, targeting patients with advanced solid tumors.

Grit Biotechnology, a leading name in TIL therapy development in China, is at the forefront of clinical-stage cell therapy. The company's core technology platforms support the development of TIL and other cell therapies. These platforms include StemTexp® (a proprietary stemness TIL expansion platform), StaViral® (a stable virus transduction system), KOReTIL® (an efficient CRISPR KO system), and ImmuT Finder® (a genome-wide CRISPR/Cas screening platform). These technologies have been instrumental in the creation of next-generation gene-edited TIL products and other cell therapies.

Beyond GT201, Grit Biotechnology is also advancing its non-gene-engineered TIL program, GT101. Currently in Phase 2 (pivotal) trials, GT101 is on course to file for a Biologics License Application (BLA) in 2025, positioning it as the leading TIL pipeline in China.

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