Imagion Receives FDA Clearance for Phase 1b/2 Trial
Key points
- FDA clears IND for MagSense® HER2 Imaging Agent
- Phase 1b/2 trial in HER2+ breast cancer patients to begin
- Anticipated patient recruitment in Q3 2026
- MagSense® aims to improve cancer detection
Full summary
Imagion Biosystems Limited (ASX: IBX) has received a Notice to Proceed from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for the MagSense® HER2 Imaging Agent. This clearance allows the company to proceed with its Phase 1b/2 clinical trial in HER2+ breast cancer patients. The trial, designed in three parts, aims to collect safety data, evaluate dosing regimens, and establish diagnostic performance. Patient recruitment is anticipated to begin in the third quarter of 2026. The MagSense® HER2 Imaging Agent, a non-radioactive MRI imaging agent, aims to improve cancer detection by adding molecular specificity, potentially transforming cancer diagnosis and treatment.
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