On July 1, the clinical trial application for AMG 910 submitted by Amgen/BeOne Medicines was accepted by the CDE. This drug is currently in Phase I clinical trials globally for gastric cancer or gastroesophageal junction cancer.
AMG 910 is a CD3/CLDN18.2 bispecific antibody. CLDN18.2 is a protein encoded by the CLDN18 gene, belonging to the claudin family of tight junction proteins, and regulates molecular flux between epithelial cell layers.
CLDN18 has two splice variants, namely CLDN18.1 and CLDN18.2. CLDN18.2 is highly expressed in various tumor tissues, such as gastric cancer (60–80%), pancreatic cancer (50%), esophageal cancer (30–50%), and lung cancer (40–60%), but is barely expressed in normal tissues. In contrast, CLDN18.1 is selectively expressed in cells of the normal lung. Therefore, specific inhibition of CLDN18.2 is widely recognized as an effective therapeutic approach for advanced or metastatic gastric cancer.