Gravel Biotech's CRISPR/AaCas12b-Based Dual-Gene Knockout TIL Therapy GT307 Receives FDA IND Approval

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On December 23, Grail Bio independently developed a new generation of gene-knockout tumor-infiltrating lymphocytes.（Tumor-Infiltrating Lymphocytes, TIL）ProductGT307 Injection, Granted by the U.S. Food and Drug Administration（FDA）New Drug Clinical Trials（IND）Approval. This is after the company's GT201 product completed clinical trials in both China and the US, Grail Biotechnology inAnother Significant Milestone Achieved in the Field of High-Safety Gene-Edited TIL, marking that the company's multiple cell therapy pipelines have entered the U.S. clinical stage.

GT307 is a next-generation dual-gene knockout TIL product based on CRISPR gene editing technology, designed to address key bottleneck issues of traditional TILs, such as susceptibility to functional exhaustion and insufficient persistence in the tumor microenvironment. GT307 is developed leveraging Grail Bio's self-developed ImmuT Finder platform.^®High-throughput immune modulation target screening platform. The company systematically discovered and identified key immune modulators that suppress the anti-tumor function of TILs, and precisely knocked them out using CRISPR technology, significantly enhancing the anti-tumor function and in vivo persistence of TILs.

In gene editing strategies,GT307 adopts the high-fidelity CRISPR/AaCas12bMAX nuclease system.Compared with the classic SpCas9 nuclease, it shows significant advantages in editing safety, product phenotype, amplification, and functionality. The relevant research results have been published in "Molecular Therapy," providing key scientific evidence for the clinical application of AaCas12bMAX nuclease in the field of cell therapy.（DOI: 10.1016/j.ymthe.2025.09.009）。

GT307 Injection Receives U.S. FDA IND Approval, Demonstrating Grit Bio's Comprehensive Strength in Next-Generation TIL Product Design and Development, Gene Editing Safety Control, Process Development, Quality Control, and International Regulatory Compliance System Construction.GT307: The world's only TIL product showing efficacy in cold tumors., validating the clinical feasibility of its innovative target selection and product strategy, and establishing its differentiated competitive advantage in the solid tumor TIL field.

Currently, GT307 InjectionChina IND SubmissionThe work is also actively advancing. In the future, Grit Bio will rely onChina-US Dual Clinical Research Platform, accelerating the advancement of GT307 in clinical research for various advanced or metastatic solid tumors, providing more cancer patients with cell therapy solutions that have breakthrough potential.

Reference: Grail Bio