Gracell Biotechnologies Receives IND Approval in China for GT101 TIL Therapy Combined with PD-1 Inhibitor as First-Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Recently, the clinical trial application (Acceptance No.: CXSL2600365) for GT101, a tumor-infiltrating lymphocyte (TIL) therapy product independently developed by Beijing Grit Biotherapeutics Co., Ltd. (hereinafter referred to as “Grit Biotherapeutics” or the “Company”), in combination with a PD-1 monoclonal antibody for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (“HNSCC”), has received implicit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration.

GT101 is a globally leading TIL cell therapy product and the first TIL therapy approved to conduct clinical trials in China. It is currently in Phase II pivotal clinical development for cervical cancer. The recent approval of the IND for GT101 in the first-line treatment of HNSCC marks a new stage in the clinical development of this TIL cell therapy for solid tumors beyond cervical cancer, further demonstrating Grit Biotherapeutics’ continued advancement in TIL therapies and next-generation solid tumor immunotherapies.

Dr. Liu Yarong, Chairman and Chief Executive Officer of Grit Biotherapeutics, stated:

"The treatment of solid tumors is highly complex, with factors such as patient population, disease stage, tumor immune microenvironment, and prior treatment history all potentially influencing the clinical performance of cell therapies. As one of the pioneering innovative cell therapy companies in China to systematically develop TIL (Tumor-Infiltrating Lymphocyte) therapy, Grit Biotherapeutics remains committed to a clinical value-driven approach, continuously advancing the clinical translation of TIL therapy for solid tumors."

As the first TIL cell therapy product approved to conduct clinical trials in China, GT101 has demonstrated positive efficacy signals and a manageable safety profile in previous clinical studies. The implicit approval by the CDE of the IND application for GT101 in combination with PD-1 monoclonal antibody for the treatment of head and neck squamous cell carcinoma marks a significant advancement for the company in the direction of combination TIL therapies.

“Looking ahead, the Company will continue to explore the therapeutic value of TIL therapy across various solid tumor indications and in combination treatment regimens, further expanding the application boundaries of next-generation cell therapies in the field of solid tumors, and striving to provide safe and effective innovative treatment options for a broader population of patients with solid tumors.”

ASCO GT101: Monotherapy Demonstrates Preliminary Antitumor Activity in Patients with Recurrent or Metastatic Cervical Cancer

Efficacy Results

• Among the 11 patients who received treatment, the objective response rate (ORR) following GT101 monotherapy was 45.5% (5/11).

• Disease Control Rate (DCR) was 90.9% (10/11).

• 4 patients (36.4%) achieved confirmed partial response (PR), and 1 patient (9.1%) achieved complete response (CR).

• Five patients (45.5%) achieved stable disease (SD).

• The median duration of response (mDoR) was 6.4 months.

• The median progression-free survival (mPFS) was 4.83 months, and overall survival (OS) is still under follow-up.

• One patient with cervical squamous cell carcinoma achieved a confirmed complete response (CR), with a duration of response of 14.5 months; the sum of diameters of target lesions at baseline was 71.57 mm, and complete response was achieved at Week 12.

Safety Results

• GT101 demonstrated a favorable and manageable safety profile.

• The majority of adverse events in the study were Grade 1–2.

• Grade ≥3 adverse events were primarily common adverse events associated with lymphocyte-depleting preconditioning and IL-2 therapy.

• Most grade ≥3 adverse events resolved or improved to grade ≤2 within 14 days.

• No treatment-related serious adverse events (SAEs) or dose-limiting toxicities (DLTs) were observed with GT101.

About GT101

As the world’s first TIL cell therapy product targeting cervical cancer, GT101 is an autologous tumor-infiltrating lymphocyte (TIL) therapy independently developed by Grit Biotherapeutics. It is currently undergoing clinical studies for indications including recurrent or metastatic cervical cancer and other solid tumors. GT101 aims to enhance patients’ own anti-tumor immune responses by isolating and expanding T cells with tumor-recognition capabilities from patient tumor tissues, followed by reinfusion. In the Phase I study announced recently, GT101 demonstrated a manageable safety profile and clinically meaningful anti-tumor activity in patients with recurrent or metastatic cervical cancer. Currently, the pivotal trial of GT101 is ongoing.

AboutGrit Biotherapeutics

Grit Biotherapeutics, founded in 2019, is an innovation-driven, late-stage clinical biopharmaceutical company.，Dedicated to pioneering next-generation immunotherapies for patients with cancer and autoimmune diseases worldwide. Leveraging profound insights in the field of immunotherapy, cutting-edge R&D and technological platforms, as well as world-class manufacturing capabilities, Grit Biotherapeutics has established multiple proprietary technology platforms in China and the United States, along with a diversified R&D pipeline comprising several candidate products, to address significant unmet clinical needs. The company’s independently developed GT101 injection is the first Tumor-Infiltrating Lymphocyte (TIL) therapy approved for registered clinical trials in China and is currently advancing into pivotal Phase II clinical trials. Its independently developed GT201 injection is the world’s first TIL product featuring membrane-bound IL-15 complexes; it has completed dual Investigational New Drug (IND) submissions in both China and the United States and has received approval to enter Phase I clinical trials. Additionally, the company boasts a portfolio of highly innovative products, including dual gene-knockout autologous TIL therapies, mRNA vaccines targeting tumor neoantigens, the world’s first universal CAR-iNKT cell therapy derived from stem cells, and next-generation in vivo CAR-T therapies, thereby forming a comprehensive product matrix focused on pan-solid tumor TIL drugs and off-the-shelf cell therapies.