Chinese biotech company Antengene Corporation Limited (SEHK:6996) announced on Tuesday that China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for the Phase I ATTRACT study of ATG-201, a CD19/CD3 bispecific T cell engager (TCE) antibody, for the treatment of B cell related autoimmune diseases.

ATG-201 is a CD19 targeting bispecific TCE incorporating steric hindrance masking technology, designed to eliminate CD19-expressing B cells. The company says that this bispecific interaction with T and B cells through CD3 and CD19 has demonstrated potential in treating B cell-driven diseases by leveraging the body's own immune system for precise and potent action. Antengene intends to promptly initiate and advance the Phase I ATTRACT study in China, while concurrently preparing for the clinical development of ATG-201 in Australia.

The ATTRACT study is designed to evaluate the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell related autoimmune diseases. Primary objectives are to evaluate the safety and tolerability of ATG-201 monotherapy and to determine its recommended Phase II dose (RP2D). Secondary objectives include evaluating the pharmacokinetic and pharmacodynamic profiles, immunogenicity, preliminary efficacy of ATG-201.

Antengene and UCB (Euronext Brussels:UCB) have entered into an agreement that grants UCB a worldwide exclusive licence to develop, manufacture, and commercialise ATG-201, along with access to its associated manufacturing technology. Antengene will conduct the first-in-human Phase I clinical trials in China and Australia, and thereafter transfer all further clinical development activities to UCB.