Transcenta’s Osemitamab (TST001) Targeting Claudin18.2 Granted Orphan Drug Designation for Treatment of Pancreatic Cancer

Transcenta, a clinical-stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Osemitamab (TST001), its high affinity humanized ADCC-enhanced monoclonal antibody, for the treatment of patients with pancreatic cancer. This is the second Orphan Drug Designation for Osemitamab (TST001), following its designation in 2021 for the treatment of gastric cancer and gastroesophageal junction cancer.

Orphan drugs are used for the prevention, treatment, and diagnosis of rare diseases. The ODD granted by the US FDA is applicable to drugs and biologics for rare diseases with less than 200,000 patients in the United States each year. The drugs that have been certified can potentially enjoy tax incentives in the United States, a seven-year market exclusivity period after listing, as well as other policy incentives.

Pancreatic cancer is one of the most challenging cancers to treat, as it 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. According to the data from National Institutes of Health, it is estimated that in 2022 approximately 62,200 people will be diagnosed with pancreatic cancer and approximately 50,000 will die from the disease.

Previously Transcenta presented preliminary anti-tumor activity data in pancreatic cancer of Osemitamab (TST001) at the 2022 International Gastric Cancer Congress, the data 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.

“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.