29 Mar 2023: Osemitamab (TST001) / Pancreatic Cancer / Transcenta: US FDA granted Orphan Drug Designation
FDA has granted Orphan Drug Designation to Osemitamab (TST001) for the treatment of patients with pancreatic cancer
Osemitamab has been designated as an orphan drug for the second time, following its designation in 2021 for the treatment of gastric cancer and gastroesophageal junction cancer
Osemitamab is a humanized anti-Claudin18.2 monoclonal antibody with high affinity and enhanced antibody-dependent cellular cytotoxicity (ADCC)
“Osemitamab (TST001) is currently being evaluated for the treatment of different Claudin18.2 positive indications. We believe it also has the potential to be transformative for advanced pancreatic adenocarcinoma who lack effective therapeutic options. We look forward to progressing our program in this indication.” said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development, and Chief Medical Officer