Antengene Corporation (Antengene) has announced that its Phase 1 ATTRACT clinical study of ATG-201, a proprietary CD19/CD3 bispecific T-cell engager 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 T-Cell Engager (TCE) that incorporates steric-hindrance masking technology and is designed to selectively eliminate CD19-expressing B cells. By simultaneously engaging CD19 on B cells and CD3 on T cells, the investigational therapy is intended to harness the body’s immune system to target B cells that contribute to autoimmune disease.

The Phase 1 ATTRACT study will evaluate the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell-related autoimmune diseases. The study will comprise dose-escalation and dose-expansion phases.

The primary objectives are to assess the safety and tolerability of ATG-201 and determine its recommended Phase 2 dose (RP2D). Secondary assessments will examine the drug’s pharmacokinetic and pharmacodynamic profiles, immunogenicity and preliminary efficacy.

The Australian regulatory milestone follows the clearance of ATG-201’s clinical trial application by China’s National Medical Products Administration (NMPA) in June 2026, marking another step in Antengene’s strategy to develop the programme across multiple clinical markets.

Antengene has entered into an agreement with UCB granting the company worldwide exclusive rights to further develop, manufacture and commercialise ATG-201, along with access to associated manufacturing technology. Under the agreement, Antengene will conduct Phase I clinical trials in China and Australia.

The simultaneous advancement of ATG-201 in China and Australia is expected to support its development as a potential global treatment programme for B cell-driven autoimmune diseases. The company said the milestones also demonstrate its ability to advance clinical programmes across key international markets while expanding its development focus beyond oncology and haematology.

ATG-201 is being developed using Antengene’s proprietary T-cell engager technology platform. The company is seeking to develop differentiated therapies for diseases with significant unmet medical needs, including autoimmune conditions where targeted depletion of pathogenic B cells could offer a potential therapeutic approach.

Antengene’s broader pipeline includes investigational programmes spanning oncology, haematology and autoimmune diseases, with candidates including ATG-022, ATG-037, ATG-101, ATG-125 and ATG-207, alongside additional T-cell engager programmes developed using its proprietary platform.