Gravel Biotech's Next-Gen TIL Therapy GT307 Receives FDA IND Approval
Grit Biotherapeutics
Developer of Immunotherapy Drugs for Solid Tumors
12Month23Date, Grail Bio independently developed a new generation of gene-knockout tumor-infiltrating lymphocytes (Tumor-Infiltrating Lymphocytes, TIL) ProductGT307Injection, approved by the U.S. Food and Drug Administration (FDA) New Drug Clinical Trial (IND) Approval.
GT307Is a product based onCRISPRNext-Generation Dual-Gene Knockout Type of Gene Editing TechnologyTILProduct, aimed at solving traditionalTILKey bottleneck issues such as functional exhaustion and insufficient persistence tend to occur in the tumor microenvironment. Relying on Grail Bio's independently developed...ImmuT Finder®High-throughput immune regulation target screening platform, the company systematically discovered and identified inhibitorsTILKey immune regulatory factors for anti-tumor function, and throughCRISPRTechniques for precise knockout significantly enhanceTILAntitumor function and in vivo persistence.
In gene editing strategies,GT307Using high-fidelityCRISPR/AaCas12bMAXNuclease system, compared to the classical SpCas9 Nucleases have demonstrated significant advantages in editing safety, product phenotype, amplification, and functionality. Relevant research findings have been published in the journal 《Molecular Therapy》（DOI: 10.1016/j.ymthe.2025.09.009). The study shows,GT307Achieved zero off-target effects and an ultra-low frequency of chromosomal structural variations, providing strong data support for the safety of its gene editing.
Gravel Biotech was founded in2019Year, is a company focused on immunocyte therapy, withTILAn innovative pharmaceutical company with a research and development pipeline represented by cell therapy and off-the-shelf cell therapy. The company's self-developedGT101The injection is the first clinically approved product in China.TILDrug, currently entering a critical phaseIIPhase Clinical Trial. World's First Membrane-BoundIL-15Complex Editor TypeTILProductGT201The injectable solution has completed dual clinical trial applications in China and the United States.
GT307Obtained in the United StatesFDA INDApproval reflects Grail Bio's advancement in the next generationTILThe strength in product design and development, safety control of gene editing, etc. It is reported that,GT307Is the only one in the world that has shown efficacy in cold tumors.TIL Product. Currently,GT307ChinaINDThe application process is also being actively promoted.
PharmaCube Pro