Radiopharm Theranostics receives FDA Orphan Drug Designation for trivehexin in pancreatic cancer

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The US FDA has granted orphan drug designation to Radiopharm Theranostics' (ASX:RAD) Ga68-Trivehexin (RAD 301) radiopharmaceutical technology for imaging patients with pancreatic ductal adenocarcinoma.

The company is developing Trivehexin as a novel radiopharmaceutical for the imaging and treatment of pancreatic cancer.

Trivehexin is a proprietary peptide-based molecule that targets αvβ6-integrin, a cellular marker for tumour invasion and metastatic growth, the expression of which correlates with decreased survival in several carcinomas.

The αvβ6-integrin receptor is found in high density on most pancreatic carcinoma cells, making it an attractive diagnostic and therapeutic target.

“Orphan Drug Designation for RAD 301 comes on top of FDA IND approval for a Phase I clinical trial in pancreatic cancer, which is planned to start in the next few weeks in the United States,” said Riccardo Canevari, CEO and managing director of Radiopharm Theranostics.

“This important designation further reinforces the excitement of investigators conducting the study. The FDA’s decision highlights the significant demand for effective imaging agents for improved and earlier diagnosis of pancreatic cancer, which has one of the highest levels of unmet needs among all cancer types.”

The company said it now holds two FDA Orphan Drug Designations, along with the LRRC15 antibody DUNP19 for treating patients with osteosarcoma.

Radiopharm signed an exclusive licensing agreement with TRIMT GmbH to develop and commercialise RAD 301 in the US, Australia, China, Hong Kong, and Japan.