Proactive’s Tylah Tullys breaks down ‘Just the Facts’ from Imugene Ltd (ASX:IMU, OTC:IUGNF) latest ASX announcement.
It has received Orphan Drug Designation (ODD) from the United States FDA for its oncolytic virotherapy, CF33-hNIS (VAXINIA). This therapy is being developed for the treatment of cholangiocarcinoma, a rare and aggressive bile tract cancer. The ODD is granted to encourage the development of treatments for diseases affecting fewer than 200,000 people in the U.S. It offers several benefits, such as tax credits, grant funding, a waiver of the $3 million Prescription Drug User Fee, and seven years of market exclusivity upon approval.
Imugene's ODD application was supported by data from its Phase 1 Metastatic Advanced Solid Tumours (MAST) trial, which evaluated VAXINIA’s safety and efficacy. Results included a complete response in one patient and stable disease in another. The MAST trial is currently in the dose-escalation phase and has been expanded to include 10 patients with bile tract cancers.
The company views the ODD as a significant achievement, reflecting VAXINIA's potential to address the need for new treatments in cholangiocarcinoma, a condition with limited therapeutic options.