Radiopharm Theranostics announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Ga68-Trivehexin (RAD 301) radiopharmaceutical technology for imaging of patients with pancreatic ductal adenocarcinoma (PDAC). Radiopharm is developing Trivehexin as a novel radiopharmaceutical for imaging and treatment of pancreatic cancer. Trivehexin is a proprietary peptide-based molecule that targets avb6-integrin, a cellular marker for tumor invasion and metastatic growth, the expression of which correlates with decreased survival in several carcinomas.

The avb6-integrin receptor is found in high density on most pancreatic carcinoma cells, making it an attractive diagnostic and therapeutic target. The Company now holds two FDA Orphan Drug Designations, along with the LRRC15 antibody DUNP19 for the treatment of patients with osteosarcoma. Designation is granted for a drug or biologic product with the potential to diagnose, prevent or treat rare diseases and conditions.

Recipients of the designation receive benefits and incentives including tax credits for qualified clinical trials, exemption from user fees and a potential seven years of market exclusivity if the drug is approved. Radiopharm signed an exclusive licensing agreement with TRIMT GmbH for development and commercialization of RAD 301 in USA, Australia, China, Hong Kong, and Japan.