Osemitamab Gets Orphan Drug Status for Pancreatic Cancer

The Food and Drug Administration (FDA) has granted Orphan Drug designation to osemitamab (TST001) for the treatment of patients with pancreatic cancer.

Osemitamab is a high affinity, humanized antibody-dependent cellular cytotoxicity (ADCC)-enhanced anti-Claudin18.2 monoclonal antibody. Preclinical studies have shown that osemitamab demonstrated potent antitumor activities in Claudin18.2 expressing pancreatic cancer tumor models independent of Kras mutation status. 

The designation is supported by preliminary antitumor activity data from a phase 1/2a trial (ClinicalTrials.gov Identifier: NCT04495296) which demonstrated that monotherapy treatment with osemitamab achieved a prolonged partial response in a Claudin18.2 low expressing pancreatic cancer patient who progressed from multiple cycles of chemotherapy. 

“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.