Antengene-B (06996) has announced a significant regulatory milestone, with its self-developed investigational drug ATG-201 receiving approval from the Australian Human Research Ethics Committee (HREC) for the Phase I ATTRACT study.
ATG-201 is a CD19/CD3 bispecific T-cell engager antibody designed to target B-cell mediated autoimmune diseases, marking an important step forward in the company's clinical development pipeline.
The company's board confirmed that in addition to the HREC approval, the clinical trial notification (CTN) submission process with the Therapeutic Goods Administration (TGA) has also been completed, paving the way for the trial's initiation in Australia.