Highlights
- Orphan Drug Designation (ODD) has been secured from the US FDA for VAXINIA (CF33-hNIS).
- Benefits of ODD include grant funding, tax credits, fee waivers, and seven years of market exclusivity following FDA approval.
- The MAST trial, which supported the FDA application, has expanded to include an additional cohort of 10 patients with bile duct cancers.
Imugene Limited (ASX:IMU) has achieved a significant regulatory milestone. The U.SFood and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for IMU’s VAXINIA, a novel oncolytic virotherapy (CF33-hNIS)This drug is being investigated for the treatment of cholangiocarcinoma, an aggressive form of bile tract cancer that affects fewer than 200k people in the US.
The FDA's Orphan Drug Designation provides several potential benefits to Imugene, including eligibility for grant funding, tax credits on clinical research costs, waiver for certain application fees, and seven years of market exclusivity if the drug receives FDA approval.
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Imugene’s application for ODD was supported by recent data from its ongoing Phase 1 MAST trial, which aims at evaluating the efficacy and safety of VAXINIAEncouraging outcomes have been reported, including one patient with cholangiocarcinoma achieving a complete response and another maintaining stable disease following treatment with VAXINIA.
The MAST trial is currently in the dose-escalation stage and is testing the oncolytic virus both as a standalone treatment and in combination with checkpoint inhibitorsThe company also has expanded the trial to include an additional cohort of 10 patients with bile duct cancers, including those diagnosed with cholangiocarcinoma.
Data source: Company update
IMU share price was AU$0.051 during early morning trading hours on 19 September 2024.