Gracell Biotechnologies Receives FDA IND Approval for GT201, a First-in-Class Membrane-Bound IL-15 Complex-Engineered TIL Therapy

Sep 02, 2024 16:06 CST Updated 16:06

Grit Biotherapeutics

Developer of Immunotherapy Drugs for Solid Tumors

In August 2024, Grit Biotechnology's GT201 injection, the world's first membrane-bound IL-15 complex-engineered TIL (Tumor-Infiltrating Lymphocyte) product, reached a significant milestone. Recently, following its IND approval in China in July 2023, GT201 successfully obtained IND approval from the U.S. FDA, marking a new chapter for Grit Biotechnology to initiate clinical trials in the U.S. market. In the Phase 1 clinical study in China, GT201 injection demonstrated excellent safety and promising clinical efficacy, with related clinical research findings presented at the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024).

TIL Therapy Shows Significant Efficacy in the Treatment of Various Solid Tumors, Greatly Extending the Survival of Advanced-Stage Patients. However, during the large-scale expansion of TIL cells, their functionality may decline or become exhausted, affecting anti-tumor efficacy and long-term outcomes. In response, Grail Bio has meticulously designed a genetically engineered TIL product, GT201, which enhances the persistence and anti-tumor capabilities of TIL cells in vivo by overexpressing a membrane-bound IL-15 complex that boosts T-cell function.

In terms of design, GT201 differs from other cell products that overexpress secreted or membrane-bound IL-15, as it chooses to overexpress the membrane-bound IL-15/IL-15Ra complex. This unique design enables GT201 to enhance its functionality while ensuring good safety, thereby improving therapeutic efficacy across a broader range of solid tumor indications.

In terms of safety, GT201 performed well, with no serious adverse events directly related to GT201 TIL cells observed. All adverse reactions disappeared or dropped to grade 2 or lower within 14 days.

In terms of clinical efficacy, the tumors of many patients significantly shrank and their conditions improved. One patient experienced a 69% reduction in tumor size after receiving GT201 treatment compared to before 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 steadily expanded in all patients, and GT201 cells persisted and expanded in patients for over six months.

For patients with advanced or metastatic solid tumors who have undergone multiple lines of treatment, Grit Biotechnology's GT201 injection has demonstrated controllable safety and favorable clinical efficacy.

E.N.D

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