The US Food and Drug Administration 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-enhanced anti-CLDN18.2 monoclonal antibody.

In preclinical studies, osemitamab demonstrated antitumor activity in CLDN18.2-expressing pancreatic cancer models, independent of KRAS mutation status. 

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The orphan drug designation for osemitamab is supported by preliminary antitumor activity observed in a phase 1/2a trial ( Identifier: NCT04495296). Osemitamab produced a prolonged partial response in a patient with CLDN18.2-low expressing pancreatic cancer that progressed on multiple cycles of chemotherapy. 

Osemitamab also has orphan drug designation for the treatment of gastric cancer and gastroesophageal junction cancer.


Transcenta’s osemitamab (TST001) targeting Claudin18.2 granted orphan drug designation for treatment of pancreatic cancer. News release. Transcenta Holding Limited. Accessed March 29, 2023.

This article originally appeared on MPR