The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
News|Articles|October 25, 2013
Ganymed's IMAB362 Receives Orphan Drug Designation From FDA and EMA
Author(s)Pharmaceutical Technology Editors
Ganymed Pharmaceuticals receives orphan drug designation from FDA and EMA for IMAB362 for the treatment of pancreatic cancer.
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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.
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