Sherpa-Backed Gravel Biotech's Next-Gen CRISPR-Edited TIL Therapy GT307 Receives FDA IND Approval

Dec 24, 2025 18:48 CST Updated 18:48

Grit Biotherapeutics

Developer of Immunotherapy Drugs for Solid Tumors

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On December 23, 2025, GT307 Injection, a next-generation gene-knockout Tumor-Infiltrating Lymphocytes (TIL) product independently developed by Sherpa Venture-backed Grail Bio, received approval from the U.S. Food and Drug Administration (FDA) for a new drug clinical trial (IND). This marks another significant milestone in the field of high-safety gene-edited TILs following the completion of clinical applications for the company’s GT201 product in both China and the U.S., signifying that multiple cell therapy pipelines of Grail Bio have entered the U.S. clinical stage.

On December 23, 2025, GT307 Injection, a next-generation gene-knockout Tumor-Infiltrating Lymphocytes (TIL) product independently developed by Sherpa Investment-backed Grail Bio, received approval from the U.S. Food and Drug Administration (FDA) for a new drug clinical trial (IND). This marks another significant milestone in the field of high-safety gene-edited TILs following the completion of clinical applications for the company’s GT201 product in both China and the U.S., indicating that multiple cell therapy pipelines of Grail Bio 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 bottlenecks of traditional TILs, such as susceptibility to functional exhaustion and insufficient persistence in the tumor microenvironment. Relying on Gracell Bio's proprietary ImmuT Finder® high-throughput immune regulatory target screening platform, the company systematically discovered and identified critical immune modulatory factors that suppress TIL anti-tumor functions, and precisely knocked them out using CRISPR technology, significantly enhancing the anti-tumor functionality and in vivo persistence of TILs.

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

Centered on this editing technology system, Grail Bio has established compliance with FDA guidelines.Systematic Safety Assessment Framework, covering key dimensions such as off-target risks and chromosomal structural variations. This evaluation system systematically supports the preclinical safety study of GT307 injection. The research results show that GT307 injection has achievedZero off-target, ultra-low frequency of chromosomal structural variations, providing strong data support for the safety of its gene editing. As an important part of the submission materials, the safety study, together with core modules such as CMC and clinical research, forms a complete set of submission documents, supporting the smooth approval of GT307 Injection by the U.S. FDA IND. During the FDA's review and information exchange process, the safety study did not trigger further supplementary study requirements, indicating the reliability and applicability of this safety assessment plan in actual submissions.Provided a practical reference for the international clinical application of gene-edited cell products.。

The approval of GT307 Injection by the U.S. FDA for IND application fully demonstrates Grail Bio's comprehensive capabilities in the design and development of next-generation TIL products, safety control in gene editing, process development, quality control, as well as the establishment of an international regulatory compliance system.GT307, as the world's only TIL product showing efficacy in cold tumors, verified itsInnovative Target SelectionThe clinical feasibility of the product strategy has established 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 clinical research of GT307 in various advanced or metastatic solid tumors, providing more cancer patients with cell therapy solutions that have breakthrough potential.

About Gravel Bio

Grit Bio was founded in 2019 as an innovative pharmaceutical company focused on immune cell therapy, with R&D pipelines represented by TIL cell therapy and off-the-shelf cell therapy. Grit Bio has completed multiple rounds of equity financing, receiving support from several well-known venture capital funds both in China and internationally.

GT101 Injection, independently developed by Grail Bio, is the first TIL drug in China to be approved for clinical trials. It is currently in the critical phase II clinical trial stage. GT201 Injection, Grail Bio's globally pioneering membrane-bound IL-15 complex-edited TIL product, has completed dual clinical trial applications in both China and the United States. The company’s core R&D platforms include the StemTexp® stem-like TIL expansion technology platform, StaViral® stable viral production system, ImmuT Finder® immunomodulatory target discovery platform, and KOReTIL® highly efficient gene knockout system. Based on these platforms, a series of next-generation gene-edited TIL drugs have been developed. Additionally, Grail Bio possesses deep technological expertise in delivery systems and AI-driven neoantigen discovery. With internationally leading technical reserves and industrial resources, Grail Bio aims to create groundbreaking cell therapies, bringing new hope to patients with cancer and other diseases.

About

Sherpa Investment

Sherpa Investment is a fund management company focused on early-stage and growth-stage healthcare investments. We adhere to the philosophy of "investing early, investing in innovation, and investing accurately."Based on the long-term accumulated industry knowledge and advantageous resources,Targeting the unmet rigid clinical needs in the field of major diseases, we build an investment portfolio around tracks such as gene technology and its applications, biopharmaceuticals, device diagnostics, and digital healthcare. We expand along the depth of the industry and its upstream and downstream sectors to form enterprise synergies, with investment layouts in both China and the United States.

The Sherpa team, with both industry and investment backgrounds, actively shares operational management experience and provides a forward-looking perspective across the entire industry chain. It supports critical decision-making during key stages of enterprise development, helping companies achieve growth in business performance and corporate value. A decade of dedication, professional focus, and continuous learning has built the Sherpa Investment brand and established a comprehensive capability system encompassing project sourcing, post-investment value-added services, and exit strategies.

The medical enterprises invested in and led by Sherpa team members include over a hundred companies such as Innovent Biologics, New Horizon Health, Belief BioMed, Berry Genomics, NanoView Biosciences, Singleron Biotechnologies, NorthX Biologics, Wuxi AppTec, Wuxi Biologics, Cytek Biosciences, Axonics, Urotronic, Visen Pharmaceuticals, Avida Biomed, Alamar Biosciences, Bota Biosciences, Vazyme Biotech, HoyoGene, Xinwei Medical, Olive Branch Health, Jianhai Technology, and Mekodakon.

Adhering to the values of "investing in health, achieving success for others and oneself," the Sherpa team is honored to join hands with many outstanding entrepreneurs. Through innovative technologies and products, we contribute to human health, participate in and witness the growth of China's medical industry together, and strive to become the most trusted Sherpa for entrepreneurs scaling the peak of life sciences.

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