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Antengene Receives Clinical Trial Approval in Australia for Phase I ATTRACT Study of ATG-201 (CD19 x CD3 TCE) in B Cell-related Autoimmune Diseases
The study will test safety, tolerability and preliminary efficacy in adult patients as Antengene advances a multi-regional autoimmune disease program.
- On Monday, Antengene Corporation Limited received approval from the Human Research Ethics Committee in Australia for the Phase I ATTRACT study of its proprietary ATG-201, a CD19/CD3 bispecific T-cell engager antibody for B cell-related autoimmune diseases.
- The drug utilizes the proprietary AnTenGager 2.0 platform, featuring "2+1" bivalent binding to minimize cytokine release syndrome while targeting CD19-expressing B cells through the body's immune system.
- This Australian approval follows clearance from China's NMPA in June, advancing Antengene's multi-regional development strategy; additionally, Antengene granted UCB worldwide exclusive rights to develop, manufacture, and commercialize ATG-201.
- The ATTRACT study will consist of two phases: dose escalation and dose expansion, with primary objectives including evaluating safety and tolerability of ATG-201 monotherapy to determine the recommended Phase II dose.
- To date, Antengene has obtained 34 investigational new drug approvals in the U.S. and Asia, remaining committed to developing differentiated, first-in-class therapies for patients addressing significant unmet medical needs worldwide.
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Antengene Receives Clinical Trial Approval in Australia for Phase I ATTRACT Study of ATG-201 (CD19 x CD3 TCE) in B Cell-related Autoimmune Diseases
SHANGHAI and HONG KONG, Aug. 24, 2026 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies,…
·Pennsylvania, United States
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