Radiopharm Theranostics has recently unveiled an innovative radiopharmaceutical technology called Ga68-Trivehexin (RAD 301). This ground-breaking drug is designed specifically for imaging patients with pancreatic ductal adenocarcinoma (PDAC).
Recognizing its potential, the U.S. Food and Drug Administration (FDA) has granted Trivehexin orphan drug designation.
Radiopharm is currently in the process of developing Trivehexin, an innovative radiopharmaceutical intended for both imaging and treatment of pancreatic cancer. Trivehexin stands out as a unique peptide-based molecule designed to specifically target αvβ6-integrin, a cellular marker associated with tumor invasion and metastatic growth.
The expression of αvβ6-integrin has been found to correlate with reduced survival rates in several types of carcinomas. Through the development of Trivehexin, Radiopharm aims to provide new possibilities for improved imaging and therapeutic approaches in the realm of pancreatic cancer.
The αvβ6-integrin receptor is a viable target for both diagnostic and therapeutic applications due to its high density on pancreatic cancer cells.
Notably, the company has received two FDA Orphan Drug Designations, one for the LRRC15 antibody DUNP19, which is designed for the treatment of osteosarcoma patients. This classification is given to medications or biological products that have the ability to diagnose, prevent, or treat rare diseases and ailments.
Those who receive the designation are entitled to various benefits and incentives, such as tax credits for eligible clinical trials, exemption from user fees, and the possibility of up to seven years of market exclusivity upon drug approval.
In line with this, Radiopharm has entered into an exclusive licensing agreement with TRIMT GmbH. This agreement grants Radiopharm the exclusive rights for the development and commercialization of RAD 301 in the United States, Australia, China, Hong Kong, and Japan. This strategic partnership sets the stage for advancing RAD 301 in these key markets.