Topnovate Biotech Launches First-in-Class B7-H3-Targeted CAR-T Therapy TX103 in Pivotal Phase I Clinical Trial for Recurrent or Progressive Grade 4 Glioma Across U.S. and China

Recently, Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. (hereinafter referred to as "Tuoxin Tiancheng") held a meeting at Beijing Tiantan Hospital, Capital Medical University, regarding the B7-H3-targeted chimeric antigen receptor T-cell (TX103).Kick-off Meeting for the Phase I Clinical Trial in China for the Treatment of Recurrent or Progressive Grade 4 Glioblastoma, and has begun recruiting participants. This trial is the world's first China-US dual-registration clinical trial of B7-H3 CAR-T cell therapy for glioblastoma, and will be conducted simultaneously in both China and the United States.In China, the study is led by Director Nan Ji of the Neurosurgery Department at Tiantan Hospital, with participation from the Neurology Department at Shijitan Hospital. This marks an important milestone for Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. in advancing its globally leading CAR-T cell therapy for solid tumors.

Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd.'s TX103 CAR-T Cell Therapy for the Treatment of Recurrent and Progressive Grade 4 Glioblastoma: Phase I Clinical Trial Approved by the U.S. Food and Drug Administration (FDA) in October 2023 and by the Center for Drug Evaluation (CDE) of the National Medical Products Administration in January 2024. The study is designed as a single-arm, open-label, dose-escalation multicenter collaborative trial.Its main purpose is to evaluate the safety of TX103 injection in treating recurrent and progressive grade 4 glioma, further confirm the appropriate dosage and usage, and verify its efficacy. 

Grade 4 glioma is one of the most aggressive and difficult tumors to treat. It shows very limited response to existing treatments such as surgery, radiotherapy, and chemotherapy, with nearly a 100% recurrence rate. The median survival for patients with recurrent grade 4 glioma is only 6-8 months, urgently requiring us to explore new treatment methods.

CAR-T Cell Therapy: Revolutionizing Cancer TreatmentCAR-T cell therapy genetically engineers a patient's T cells to enable them to recognize and attack tumor cells. In the field of hematologic malignancies, CAR-T cell therapy has achieved remarkable success, but its application in solid tumors is still under exploration. Excitingly, novel CAR-T therapies targeting glioblastoma are gradually advancing and have already shown significant progress.

The Principal Investigator (PI) of this trial）Professor Ji Nan pointed out: "TX103, a CAR-T cell therapy targeting B7-H3 developed by Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd., has brought us new hope.B7-H3 is expressed in nearly 100% of grade 4 gliomas and is highly expressed in 70% of patients.By targeting this site, CAR-T cells can precisely identify and attack tumor cells.

In our earlier IIT studies, TX103 demonstrated good safety and positive efficacy signals. The results were presented at this year’s ASCO meeting, drawing widespread attention from the industry. As a neurosurgeon, I am hopeful about the future of TX103 and look forward to TX103 cell therapy becoming a new breakthrough in the treatment of glioblastoma, bringing new hope for patients in terms of efficacy and survival.

TX103 is a CAR-T cell therapy drug independently developed by Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd., with patents authorized in China and internationally, targeting B7-H3. The preliminary clinical results of TX103 in treating recurrent glioblastoma were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting; current research findings indicate that no dose-limiting toxicity has been observed in any patients to date, demonstrating good safety.Compared with the median survival time of 6-8 months for recurrent glioma patients, TX103 showed significant improvements in both median survival rate and 12-month overall survival rate.; At the same time, durable partial and complete responses were achieved in patients at the medium dose level.

Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. is a clinical-stage innovative biopharmaceutical company focused on developing T-cell immunotherapy products, founded byFounded by pioneers in tumor immunology, Professor Chen Lieping, and expert in immunocyte therapy, Professor Huang Gangxiong.Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. is a company with a mission of research and innovation, focusing on the development of innovative technologies and drugs in the field of tumor immunology and immune cell therapy. The company has established a professional team covering the entire drug development process, including scientific research, technology development, quality management, production processes and registration, and clinical research. Under the leadership of Professor Chen Lieping, the Tuoxin Tiancheng team is committed to addressing unmet medical needs by developing globally innovative immunotherapy drugs, bringing new hope to more cancer patients.