CARsgen Therapeutics’ CT041 Gets Orphan Drug Designation

The FDA has granted an Orphan Drug designation to China-based CARsgen Therapeutics’ T-cell treatment for gastric and gastroesophageal cancer, CT041.

The chimeric antigen receptor T-cell treatment is targeted for tumors with a specific protein, claudin18.2, found on cells in the lining of the gut.

The drug previously received an Investigational New Drug designation from the FDA as well as from China’s drug regulatory authority.