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In August 2024, Grail Bio's GT201 injection, the world's first membrane-bound IL-15 complex-edited TIL (Tumor Infiltrating Lymphocyte) product, achieved a significant milestone. Following its IND approval in China in July 2023, GT201 has now received IND approval from the U.S. FDA, marking a new chapter for Grail Bio to initiate clinical trials in the U.S. market.Autologous Tumor-Infiltrating Lymphocyte Injection (GT201) is a gene-edited TIL product independently developed by Grail Bio. This product exhibits stronger proliferation ability, tumor killing, cytokine release, and better persistence both in vivo and in vitro compared to traditional TILs. It also reduces dependency on IL-2, thereby overcoming the challenges faced by traditional TIL products.Fig: Schematic diagram of the structural design of GT201
GT201 is the first gene-edited TIL product in China to have applied for and received clinical trial approval, and is currently undergoing a Phase 1 clinical study for metastatic/recurrent advanced solid tumors.GT201 Injection Demonstrates Good Safety and Clinical Efficacy in Phase 1 Clinical Study in China; Relevant Clinical Research Findings Were Presented at the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024).In terms of safety, GT201 demonstrated good safety, with no SAEs directly related to GT201 TIL cells observed. All adverse reactions disappeared within 14 days or decreased to grade 2 or lower. In terms of clinical efficacy, the tumors of multiple patients significantly shrank and their conditions improved, with one patient experiencing a 69% reduction in tumor size after receiving GT201 treatment. Among all non-small cell lung cancer patients, the disease control rate (partial tumor elimination or stable condition for over 24 weeks) of GT201 reached 100%. Additionally, regarding cell persistence, after the infusion of GT201 TILs, T cells stably expanded in all patients, and the expansion and persistence of GT201 cells in patients lasted for more than 6 months.Meanwhile, another non-gene-edited drug, GT101 Injection developed by Grail Bio, has officially launched a pivotal Phase II clinical study in China. Subsequently, the recruitment of subjects with recurrent or metastatic cervical cancer will be carried out at multiple clinical centers across the country. Other pipelines of Grail Bio, such as GT201, are also recruiting patients with advanced solid tumors who have metastasized or relapsed at hospital research centers throughout China.Grit Bio was founded in 2019 as an innovative pharmaceutical company focusing on tumor immunotherapy and cell therapy, with a representative R&D pipeline of TIL drugs. Grit Bio has completed multiple rounds of equity financing and received support from several well-known venture capital funds both in China and internationally.
Source: PharmaCloud Database
The company's core R&D platforms include the StemTexp® dry TIL expansion technology platform, StaViral® viral stable transfection process, ImmuT Finder® immunomodulatory target discovery platform, and KOReTIL® high-efficiency gene knockout system, and based on these platforms, a series of next-generation gene-edited TIL drugs have been developed.Currently, there are 6 TIL drugs in its pipeline, targeting various solid tumors such as melanoma, cervical cancer, lung cancer, ovarian cancer, and gastrointestinal tumors.
Product Pipeline
Source: Grail Bio
