Gracell Biotechnologies Announces First Complete Response in Oral Cancer Patient Treated with Innovative TIL Therapy GT201 in Collaboration with Shanghai Ninth People's Hospital

Recently, according to a report from Shanghai Ninth People's Hospital, the innovative Tumor-Infiltrating Lymphocyte therapy (TIL) GT201, co-developed by Grail Bio and Shanghai Ninth People's Hospital, achieved complete response (“CR”) in the efficacy evaluation of the first head and neck cancer patient in a clinical study, with the tumor lesion completely disappeared. This marks a significant breakthrough in China in the field of TIL cell therapy for solid tumors. GT201 is a membrane-bound IL-15 complex genetically engineered Tumor-Infiltrating Lymphocyte therapy (“TIL”) product. Currently led by Dr. He Yue, Director of the Department of Oral and Maxillofacial-Head and Neck Oncology at Shanghai Ninth People's Hospital affiliated with Shanghai Jiao Tong University School of Medicine, it is being explored in advanced squamous cell carcinoma of the head and neck.

Comparison of PET-CT Images Before and After Treatment

GT201 is a retroviral platform named StaVrial, independently developed by Grail Bio with proprietary intellectual property.^®GT201, a membrane-bound IL-15 complex-engineered TIL therapy developed in-house, enhances the persistence and functionality of TIL cells while alleviating immunosuppressive effects in the tumor microenvironment. This provides a new treatment option for patients with advanced squamous cell carcinoma of the head and neck (SCCHN) who have failed first-line therapy, fully demonstrating Grail Bio's strong technical expertise and R&D capabilities. In September 2023, the team led by Professor He Yue from Shanghai Ninth People’s Hospital, in collaboration with Grail Bio, applied for the second round of the "Three-Year Action Plan to Promote Clinical Skills and Innovation in Municipal Hospitals" under the Shanghai Shenkang Hospital Development Center’s Medical-Enterprise Fusion Innovation Collaboration Program. The team led by Professor He Yue is responsible for designing and conducting clinical trials targeting oral and head and neck squamous cell carcinoma. Principal investigator Professor He Yue noted: "The five-year survival rate for SCCHN patients who fail first-line treatment is only around 20%, with very limited treatment options. Preliminary results from this clinical study show that GT201 demonstrates good safety and encouraging efficacy in patients, building confidence for subsequent studies and offering a new path for medical-enterprise collaboration." In February 2024, Lifileucel, the world’s first TIL therapy product, was approved for marketing at a price of $515,000. By comparison, significant progress has been made in the independent development and clinical trials of TIL therapies in China, providing more accessible treatment options for domestic patients.

The Department of Oral and Maxillofacial-Head and Neck Oncology at Shanghai Ninth People's Hospital, under the joint efforts of Professor Zhang Xize, Academician Qiu Weiliu, and Academician Zhang Zhiyuan, has become a leading discipline both in China and internationally. Zhang Zhiyuan's research team and Grail Biotechnology have carried out extensive research and exploration since 2019, guiding Dr. Zhou Rong and Dr. Han Yong from the research team to complete applications for multiple projects, including the National Natural Science Foundation of China. Academician Zhang Zhiyuan of the Chinese Academy of Engineering stated: "We began exploring tumor-infiltrating lymphocyte therapy more than 30 years ago, but at that time, limited by technological conditions, the results were not satisfactory. Now, with advancements in the industry, the preliminary efficacy shown by novel engineered tumor-infiltrating lymphocyte therapies undoubtedly brings new hope to patients with head and neck cancer. In the future, our department will rely on the advantageous resources of the National Center for Stomatology to focus on building immunotherapy cell treatment wards and a research platform, promoting the development of key technologies in cell-based immunotherapy, and providing continuous momentum for the development of Chinese-style oral and maxillofacial-head and neck oncology."

GT201 is a gene-engineered TIL product independently developed by Grail Bio. This product overexpresses a membrane-bound IL-15 complex that enhances T-cell function, thereby strengthening the in vivo persistence and anti-tumor capabilities of TIL cells.GT201 Injection has completed dual clinical trial applications in China and the United States, and has demonstrated good safety and clinical efficacy in clinical studies conducted in China.Relevant clinical research results have been showcased at the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024).