Tiangang Yinuo Announces First Patient Dosed in Phase I Clinical Trial of TGI-6, a Novel Bispecific Antibody for Solid Tumors

HefeiJanuary 3, 2024PR Newswire -- January 3, 2024, Hefei TG ImmunoPharma Co., Ltd. (TGI), independently developed a bispecific antibody (Project Code: TGI-6), which has completed the first patient enrollment and dosing (FPI) in Phase I clinical trial at Peking University Cancer Hospital. TGI-6 from TGI is the second product of its kind globally and the first in China to enter the clinical stage.

This clinical study (TGI6-T1-02) is a first-in-human, open-label, multi-center Phase I trial, comprising a dose-escalation phase (Phase Ia) and a dose-expansion phase (Phase Ib), enrolling subjects with locally advanced or metastatic colorectal cancer (CRC) or subjects with locally advanced or metastatic solid tumors who are target-positive. The study aims to evaluate the tolerability, safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of TGI-6 following injection in subjects. The study is led by Professor Lin Shen from Peking University Cancer Hospital and involves three clinical trial centers in China.

TGI-6 is a bispecific antibody that simultaneously targets tumor antigens (tumor ligands recognized by NK cell receptors) and T cells. This tumor antigen is highly expressed in various solid tumors, including colorectal cancer, breast cancer, liver cancer, and pancreatic cancer. Preclinical data show that TGI-6 can achieve complete tumor clearance with a single dose in animal models of different cancer types, demonstrating potent anti-tumor activity. This study has been granted clinical trial approval by the U.S. FDA in June 2023 and by China's NMPA in October 2023. The project's clinical trial kick-off meeting was successfully held on December 8, 2023, where key aspects of the clinical trial were thoroughly discussed and consensus was reached.

Professor Zhigang Tian, academician of the Chinese Academy of Engineering and founder of TGI, stated: "The completion of the first patient dosing for TGI-6 marks an important milestone, signifying that the bispecific antibody injection TGI-6 has officially entered the clinical research stage. It also marks TGI's official entry as a biopharmaceutical company into the clinical trial phase. The ongoing Phase I study, as the first human trial of TGI-6, will primarily evaluate the safety and tolerability of TGI-6, providing a basis for further clinical development. We will actively advance the clinical research of TGI-6, assessing its potential value in clinical applications more quickly and effectively. As a completely new therapeutic solution, we hope TGI-6 can benefit more patients as soon as possible, offering cancer patients more opportunities for precision treatment and bringing the latest treatment concepts and innovative drugs to patients worldwide."