Ganymed's IMAB362 Receives Orphan Drug Designation From FDA and EMA

Oct 25, 2013

Ganymed Pharmaceuticals AG, reported that  FDA and the European Medicines Agency (EMA) have granted orphan drug designation to IMAB362 for the treatment of pancreatic cancer. IMAB362 is a monoclonal antibody currently in Phase IIb clinical trial for gastroesophageal cancer.

IMAB362 is a monoclonal antibody selectively binding to the tight junction protein CLDN18.2, which is expressed in approximately 60% of primary and metastatic pancreatic cancers. CLDN18.2 is also expressed in up to 80% of gastroesophageal cancers as well as in other solid tumors. However, CLDN18.2 is absent from the vast majority of healthy tissues. This makes IMAB362 cancer cell selective with little or no effect on healthy cells and reduced risks of side effects.

Source: Ganymed Pharmaceuticals