Biopharmaceutical company Transcenta Holding Limited (Transcenta) (HKEX:06628), a provider of antibody-based therapeutics, reported on Wednesday that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to its high affinity humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody, Osemitamab (TST001), to treat pancreatic cancer patients.

Transcenta stated that this is the second Orphan Drug Designation for Osemitamab (TST001) and followins its 2021 designation for the treatment of gastric cancer and gastroesophageal junction cancer.

The company added that pancreatic cancer is often diagnosed at an advanced stage with typically poor outcomes to available therapies. The 5-year survival rate at diagnosis is around 10% and the median overall survival barely exceeds 9 months for advanced or metastatic disease.

Earlier, Transcenta presented preliminary anti-tumor activity data in pancreatic cancer of Osemitamab (TST001), which indicated that monotherapy treatment with Osemitamab (TST001) led to a prolonged partial response in a Claudin18.2 low expressing pancreatic cancer patient who progressed from multiple cycles of chemotherapy. In preclinical studies, Osemitamab (TST001) has shown potent anti-tumor activities in Claudin18.2 expressing pancreatic cancer tumor models independent of Kras mutation status.