Imagion Targets Q4 2025 FDA IND Submission Following Encouraging MagSense® Data

Imagion Biosystems and Wayne State University Collaboration

Imagion Biosystems Limited (ASX – IBX) has announced promising progress in its development of the MagSense® HER2 imaging agent, a novel molecular MRI technology aimed at improving early detection of HER2-positive breast cancer. The company’s collaboration with Wayne State University (WSU) has yielded positive and encouraging results, particularly in establishing the minimum effective dosage of the imaging agent for clinical use.

This collaboration focused on refining the dose range and optimising MRI imaging protocols, which are critical steps ahead of the planned Phase 2 clinical trial. The findings suggest that a lower dose than previously tested in Phase 1 remains detectable, a development that could enhance the safety profile of the agent and improve patient comfort during imaging procedures.

Optimised Imaging Protocols and AI-Ready Data

Beyond dosage, the WSU team has improved MRI sequences, which will form the foundation for imaging protocols in the upcoming Phase 2 trial. These optimisations are expected to deliver higher quality images, potentially increasing diagnostic accuracy. Notably, the use of quantitative imaging techniques combined with molecular agents like MagSense® may generate AI-ready data sets, opening the door to advanced diagnostic tools that could democratise and enhance cancer detection.

Manufacturing and Regulatory Milestones

Imagion Biosystems has also confirmed that manufacturing of a new batch of the MagSense® HER2 imaging agent is progressing well, with analytical testing underway in accordance with FDA guidelines. This batch will be used in the Phase 2 clinical trial once regulatory approval is secured.

The company remains on track to submit its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025. Subject to FDA approval, the Phase 2 clinical trial is expected to commence in the first quarter of 2026, marking a significant step forward in the clinical development of this promising imaging technology.

Looking Ahead

Imagion’s progress underscores the potential of MagSense® to transform cancer diagnostics by enabling earlier and more precise detection of HER2-positive breast cancer. The combination of lower effective doses, improved imaging protocols, and AI-compatible data sets positions the company well for the next phase of clinical evaluation and eventual commercialisation.