HER-Vaxx (IMU-131), the proposed drug product, and P467-CRM197, the drug substance, in 10 mM phosphate buffered saline pH 7.4 (PBS) is under development as a therapeutic vaccine for the treatment of gastric cancer in patients with human epidermal growth factor receptor 2/neu (HER-2/neu)-overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction, referred to as advanced cancer of the stomach. This evidence concerns the gene ERBB2 and gastric cancer.