Gracell Biotechnologies Receives NMPA IND Approval for GT201, China's First Gene-Edited TIL Therapy

On July 12, 2023, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration displayed that Gravel Biotherapeutics Co., Ltd. (hereinafter referred to as “Gravel Bio”) independently developedGT201 Injection(Acceptance No.: CXSL2300290) has officially received approval from the National Medical Products Administration (NMPA)Implied Approval for Clinical Trials.

 GT201 is the first gene-edited TIL drug in China to enter registration clinical trials.

GT201 is Gracell Biotechnologies’ proprietary next-generation gene-edited TIL (tumor-infiltrating lymphocyte) product that expresses membrane-bound cytokines.The Shali R&D team compared and selected the most optimized structural design in preclinical studies, and tailor-made the retroviral vector system StaViral for engineered TIL therapy.^®, enabling stable expression of the target gene in TIL cells from multiple batches and different tumor types.

 GT201 is based on the self-developed viral editing platform, StaViral.^®Next-Generation TIL Pipeline

GT201 demonstrated superior performance compared to traditional TILs both in vitro and in vivoEnhanced Proliferative Capacity, Tumor Cytotoxicity, and Cytokine ReleaseandBetter Persistence, and can reduce the dependence on IL-2, potentiallyReducing the Dosage of IL-2 in Clinical Applications, thereby overcoming the challenges faced by traditional TIL therapies. In investigator-initiated trials (IITs), the drug GT201 in the treatment ofDemonstrated a favorable safety profile in multiple patients with advanced solid tumors, and demonstrateStable expansion and preliminary clinical efficacy.

Shali Biotech is set to officially launch the Phase I clinical trial of GT201, and will recruit patients with solid tumors from the general public at that time.

GravelBio, established in 2019, is a comprehensive cell therapy company dedicated to the research, development, and clinical application of tumor-infiltrating lymphocytes (TILs). GravelBio has completed multiple rounds of equity financing and has received support from numerous renowned venture capital funds both in China and abroad.

GT101 injection, independently developed by Gravel Bio, is the first tumor-infiltrating lymphocyte (TIL) therapy approved for clinical trials in China. The company’s core R&D platforms include StemTexp^®Dry TIL Expansion Technology Platform, StaViral^®Viral Stable Cell Line Process, ImmuT Finder^®Immunomodulatory Target Discovery Platform, KOReTIL^®High-efficiency gene knockout system, leveraging the platform to develop a series of next-generation gene-edited TIL therapeutics. Gravel Bio possesses internationally leading technological reserves and industrial resources, aiming to create pioneering cell therapies for solid tumors and bring new hope to cancer patients worldwide.