China-based Antengene Corporation Limited (HKG: 6996) has announced that its in-house discovered and developed antibody drug conjugate (ADC), ATG-022, targeting Claudin 18.2, has been granted two Orphan Drug Designations (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. This brings the total number of ODDs received by Antengene from the FDA for its in-house products to three.
ATG-022: A Targeted Therapy for Claudin 18.2 Overexpression
ATG-022 is an innovative antibody-drug conjugate that targets Claudin 18.2, a protein overexpressed in various primary malignant tumors, including gastric, esophageal, and pancreatic cancers. Claudins are cell adhesion molecules that regulate cell permeability and are often expressed at the cell surface in cancer due to changes in cell polarity.
Ongoing Phase I CLINCH Study
The Phase I CLINCH study of ATG-022 in patients with advanced or metastatic solid tumors is currently underway in China and Australia, having received approval from the China National Medical Products Administration (NMPA) and Bellberry Human Research Ethics Committee (HREC) in Australia.
Significance of Gastric and Pancreatic Cancers
Gastric cancer, which arises in the gastric epithelium, was ranked ninth by mortality among all cancers according to the World Health Organization’s (WHO) 2019 statistics. In the U.S., there were an estimated 26,000 gastric cancer diagnoses and 11,000 gastric cancer-related deaths in 2022. Pancreatic cancer is a highly malignant type of gastrointestinal cancer, with over 55,000 newly diagnosed cases and 44,330 related deaths reported in the U.S. in 2018. Currently considered an orphan disease, pancreatic cancer is projected to become the second most common cause of cancer-related deaths by 2030.-Fineline Info & Tech
