GRIT Biotechnology Showcases Promising Clinical Data for Three TIL Therapies—GT101, GT201, and GT300—at ASCO 2025

Title: Assessing the Safety and Efficacy of GT201: A First-in-Class Autologous Tumor-Infiltrating Lymphocyte Monotherapy in Advanced Solid Tumors

Exhibition Time: June 2, 2025, 9:00 AM – 12:00 PM (Local Time)

Abstract Number: 6038

Poster Number: 446

Report Highlights:

Granite Bio's next-generation TIL therapy product GT201, which expresses membrane-bound IL-15, has demonstrated excellent safety and breakthrough efficacy in early clinical trials for patients with advanced solid tumors who failed multiple lines of treatment. In 9 evaluable patients, GT201 achieved an objective response rate (ORR) of 55.6% and a disease control rate (DCR) of 77.8%, showing remarkable efficacy particularly in difficult-to-treat indications such as squamous cell carcinoma of the head and neck and non-small cell lung cancer. Clinical data showed that GT201 was well-tolerated, with no grade 3 or higher treatment-related adverse events observed. After infusion, the gene-edited TIL cells persisted durably in vivo. These results preliminarily highlight the significant potential of the GT201 product in clinical development.

Poster 3

Title: Evaluating the Safety and Efficacy of CRISPR/Cas12b-Modified Tumor Infiltrating Lymphocytes (GT300) as Monotherapy in Advanced Solid Tumors

Exhibition Time: June 1, 2025, 9:00 AM – 12:00 PM (Local Time)

Abstract Number: 5613

Poster Number: 511

Report Highlights:

GT300 is a next-generation TIL product genetically engineered using CRISPR/AaCas12bMax, designed to overcome the immunosuppressive microenvironment in "cold tumors." As the first CRISPR gene-edited TIL therapy applied in clinical practice, GT300 has preliminarily demonstrated excellent efficacy and good safety in treating drug-resistant gynecological malignancies. Among a total of 5 enrolled patients, GT300 achieved an objective response rate (ORR) of 60%, including 2 complete responses and 1 partial response, with no dose-limiting toxicity observed. Significant TIL expansion and an early increase in IFN-γ levels closely associated with clinical benefit were detected post-infusion, preliminarily demonstrating GT300’s potential to induce durable immune responses in "cold tumors."

In recent years, the global conferences that Grit Biotechnology has participated in also include:

At the 2025 American Society of Gene & Cell Therapy (ASGCT), three groundbreaking research achievements were announced, including a next-generation tumor neoantigen vaccine utilizing a combined antigen-presenting cell (APC) targeted delivery platform, an innovative tumor-infiltrating lymphocyte (TIL) editing approach based on a lipid nanoparticle (LNP) system, and a universal in vivo CAR-T cell therapy driven by an LNP system targeting T cells.

At the 2025 American Association for Cancer Research (AACR), three innovative research data were announced, including two next-generation gene-edited tumor-infiltrating lymphocytes (TIL) based on CRISPR technology, and a next-generation neoantigen vaccine based on an artificial intelligence-assisted discovery and antigen-presenting cell (APC) targeted delivery platform.

At the 2024 Society for Immunotherapy of Cancer (SITC), a series of latest research achievements in the field of cell therapy were announced, including: the application of patient-derived autologous organoids (PDO) to enrich tumor-specific TILs, the preparation of next-generation gene-edited TILs supported by the AaCas12bMax technology platform from Tianze CloudTech, and the clinical trial design for the next-generation gene-edited TIL therapy GT300.

At the 2024 TIL Therapies Summit, share the potential and opportunities of Tumor Infiltrating Lymphocyte (TIL) therapy in achieving breakthroughs across more indications through various formats such as expert panel discussions and keynote presentations, and showcase the company’s R&D progress and clinical trial results for next-generation gene-edited TIL products.

At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, a series of latest research achievements in the field of cell therapy were announced: Phase I clinical data for TIL injection GT101 demonstrated good safety and clinical efficacy in multiple patients with advanced solid tumors; the latest Phase I clinical data for GT201, the world's first membrane-bound IL-15 complex-edited TIL injection, showed good safety and clinical efficacy in several patients with advanced solid tumors; and GT316, the world’s first CRISPR dual-target gene-edited TIL injection, also exhibited good safety and clinical efficacy in multiple patients with advanced solid tumors.

At the 2024 Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), a series of latest research findings in the field of cell therapy were announced: The high-throughput CRISPR screening platform ImmuT Finder® aided in the discovery of key immune regulatory targets in NK cells, the latest preclinical and clinical data of the dual-knockout TIL product GT316 with anti-exhaustion capabilities, and the latest research achievements from external collaboration projects: the latest data on identifying novel antigen-presenting cell-targeting LNPs for mRNA tumor vaccine development.

At the 2024 American Association for Cancer Research (AACR) Annual Meeting, two latest research achievements in the TIL (Tumor-Infiltrating Lymphocytes) field were announced: GT216, a novel gene-edited TIL product designed to enhance efficacy in solid tumors, and the latest data on GT307, a next-generation dual-knockout TIL product based on the high-throughput CRISPR screening platform ImmuT Finder®.

At the 2023 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), the company fully showcased its screening achievements of tumor-reactive biomarkers during the TIL in vitro expansion phase.

At the 2023 TIL Therapies Summit, the company announced the latest preclinical and clinical trial results of its high-throughput CRISPR screening platform, ImmuT Finder®, and the next-generation double-knockout TIL product, GT316, developed based on this platform.

At the 2023 American Association for Cancer Research (AACR) Annual Meeting, the company announced its high-throughput CRISPR screening platform ImmuT Finder® and the preclinical study of the next-generation double-knockout TIL product GT316 developed based on this platform.

At the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, the company announced the clinical trial progress of its GT201 product. GT201 demonstrated stable amplification capability and showed good safety and preliminary clinical efficacy in multiple patients with advanced solid tumors.

At the 2023 Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), the company presented preclinical research findings on its next-generation gene-edited TIL product, GT201. Using a customized retroviral system designed for engineered TIL therapy, GT201 achieved stable expression and functional enhancement across multiple batches of TIL cells derived from various tumor types.

At the 2022 American Association for Cancer Research (AACR) Annual Meeting, the company unveiled the technical highlights of its proprietary TIL stemness expansion platform, StemTexp®, as well as the next-generation TIL product GT202, developed based on the viral process platform StaViral®.

Grit Bio was founded in 2019 as an innovative pharmaceutical company focused on tumor immunotherapy and the development of TIL-based drug pipelines. 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 Grit Bio, is the first TIL drug in China to be approved for registrational clinical trials and has now entered a pivotal Phase II clinical trial. GT201 Injection, the world’s first membrane-bound IL-15 complex-engineered TIL product developed by Grit Bio, has completed dual IND submissions in both China and the U.S. The company's core R&D platforms include StemTexp® (a stem-like TIL expansion technology platform), StaViral® (a stable viral production process), ImmuT Finder® (an immune-modulatory target discovery platform), and KOReTIL® (a highly efficient gene knockout system). Based on these platforms, Grit Bio has developed a series of next-generation gene-edited TIL drugs. With leading international technological expertise and industry resources, Grit Bio aims to create groundbreaking cell therapies for solid tumors, bringing new hope to cancer patients worldwide.