Commercial-stage biotech company Antengene Corporation Limited (SEHK:6996.HK) announced on Monday that the Phase I ATTRACT study of its proprietary ATG-201, a CD19/CD3 bispecific T-cell engager (TCE) antibody for B cell-related autoimmune diseases, has received approval from the Human Research Ethics Committee (HREC) in Australia, and completed the Clinical Trial Notification (CTN) process with the Therapeutic Goods Administration (TGA).

ATG-201 is a CD19 targeting bispecific TCE incorporating steric hindrance masking technology, designed to eliminate CD19-expressing B cells. 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.

The Phase I clinical study is designed to evaluate the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell related autoimmune diseases. The study will consist of two phases: dose escalation and dose expansion. The primary objectives of the study 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 worldwide exclusive rights to further develop, manufacture, and commercialise ATG-201, and access to its associated manufacturing technology in relation to ATG-201. Antengene will conduct the Phase I clinical trials in China and Australia.