On September 15, Amgen/BeOne Medicines’ Class 1 new drug AMG 199 was approved for clinical trials in China, intended for the treatment of MUC17-positive gastric or gastroesophageal junction (G/GEJ) cancer.
Advanced G/GEJ cancer has a poor prognosis, creating an urgent need for new therapeutic approaches. MUC17 is a transmembrane protein overexpressed on the cell membrane of G/GEJ cancer cells, while being minimally expressed in normal cells.
AMG 199 is a CD3/MUC17 bispecific antibody that facilitates the binding of CD3-positive T cells to MUC17-positive gastric/gastroesophageal junction (G/GEJ) cancer cells, promoting cross-linking between T cells and tumor cells, and inducing T cell activation and proliferation.
Currently, the Phase I clinical trial (NCT04117958) of this drug for gastric cancer or gastroesophageal junction cancer is ongoing. In June 2020, the FDA granted orphan drug designation to AMG 199.