Antengene Receives Australian TGA Approval for ATG-018 Clinical Trial

China-based biopharma Antengene Corporation (HKG: 6996) has announced receiving approval from the Therapeutic Goods Administration (TGA) of Australia to initiate a Phase I clinical trial for its candidate ATG-018. The trial, named ATRIUM, will evaluate the drug in patients with advanced solid tumors and hematological malignancies.

Drug Mechanism
ATG-018 is an oral, potent, and selective small-molecule inhibitor of ataxia telangiectasia and Rad3-related (ATR) kinase, developed in-house by Antengene. ATR kinases are part of the phosphoinositide 3-kinase-related family, and their inhibition can increase single-strand DNA breaks, impacting DNA damage response (DDR) in tumor cells.

Pre-Clinical Findings
Pre-clinical studies indicate that ATR inhibitors, alone or in combination with other drugs (including DDR inhibitors), show therapeutic potential in various solid tumors (such as gastric, esophageal, and squamous cell carcinoma) and hematological tumors (including chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and multiple myeloma). The study also identified gene expression changes linked to ATG-018 sensitivity, suggesting potential predictive biomarkers.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry