Gravel Biotech Successfully Launches Pivotal Phase II Clinical Trial of TIL Therapy GT101 for Recurrent or Metastatic Cervical Cancer

April 1, 2024, byGravel BiotechApplication for "A Multicenter, Randomized Controlled, Open-Label Phase II Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT101 Injection) for the Treatment of Recurrent or Metastatic Cervical Cancer"Successfully held in Changsha, Hunan, in the form of online and offline meetings."

At the launch meeting, Wang Jing, President of Hunan Cancer Hospital, Zhang Yongchang, Director, and the clinical research team of the department, the Grail Bio team as the sponsor, and the ClinChoice team, among other relevant leaders, attended the meeting to jointly witness the occasion.The Smooth Launch of China's First Pivotal Phase II Clinical Trial for TIL Drugs. At the launch meeting, all parties conducted an in-depth discussion on the clinical research plan for GT101 injection and had full communication and exchange on the implementation process and corresponding details of the research plan.

GT101 injection, a TIL product independently developed and produced by Grail Bio, is China's first TIL product to enter clinical trials. Based on the Phase I trial results showing an objective response rate (ORR) of 45.5% in cervical cancer patients, GT101 has officially launched a pivotal Phase II clinical study in China. TIL therapy involves isolating tumor-infiltrating lymphocytes from tumors, expanding them in vitro, and then infusing them back into the patient. Due to the presence of a large number of patient antigen-specific TIL cells, it can specifically recognize and kill the patient’s cancer cells. The world's first TIL therapy was approved for marketing in the United States on February 16, 2024, for the treatment of advanced melanoma. The approval was primarily based on efficacy data showing an ORR of 31.4%.

The launch conference was successfully held, and subsequently, the recruitment of participants will be carried out in multiple clinical centers across China. Grail Bio will work together with clinical centers throughout China to strive for the early approval and market launch of TIL drugs in China, bringing world-leading treatment options to patients with cervical cancer.

Grit Bio was founded in 2019 as an innovative pharmaceutical company focusing on tumor immunotherapy and cell therapy, with a research and development pipeline represented by 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.

GT101 Injection, independently developed by Grail Bio, is the first TIL drug in China to be approved for registrational clinical trials and has now entered the pivotal Phase II clinical trial. The company's core R&D platforms include the StemTexp® stem-like TIL expansion technology platform, StaViral® stable viral production system, ImmuT Finder® immunomodulatory target discovery platform, and KOReTIL® high-efficiency gene knockout system, based on which a series of next-generation gene-edited TIL drugs have been developed. Grail Bio possesses world-leading technical reserves and industry resources, aiming to create groundbreaking solid tumor cell therapies and bring new hope to cancer patients.