Imagion Biosystems (ASX:IBX) has announced that it has lodged an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for its MagSense targeted imaging agent.
If approved, the filing will clear the way for a Phase 2 clinical trial focused on detecting nodal metastases in patients with HER2-positive breast cancer.
For the Melbourne-based, clinical-stage medical imaging company, the IND submission represents a regulatory milestone and a validation of scientific and operational work. Company president Ward Detwiler described the filing as a moment of pride for the organisation, crediting the team for delivering a high-quality submission and emphasising its importance in addressing an unmet need in cancer diagnosis.
At the centre of the announcement is MagSense, a first-of-its-kind molecular MRI platform that uses iron oxide nanoparticles engineered to target specific disease biomarkers, such as HER2. Unlike conventional contrast agents that distribute broadly throughout the body, MagSense is designed to be detectable only where cancer is present. When imaged with MRI, iron oxide produces a distinct, measurable contrast change, offering clinicians clearer, more precise information to guide diagnosis and treatment planning.
Detwiler characterised the technology as potentially 'game-changing' for radiologists and oncologists who must make high-stakes decisions based on imaging results. By enabling earlier and more accurate detection of cancer spread, the company believes MagSense could improve both clinical confidence and patient outcomes.
Based on historical FDA review timelines, Imagion anticipates that patient enrollment for the Phase 2 trial could begin as early as the first quarter of 2026. In preparation, the company has already engaged its strategic trial partners, initiated clinical site outreach, and begun advancing study logistics in line with Good Clinical Practice requirements.