Imagion Biosystems Advances Towards Phase 2 Trial with Positive MagSense® Dosage Results

Imagion Biosystems has reported a key development in its clinical program for HER2-positive breast cancer, with successful outcomes from a dosage optimisation study conducted in collaboration with Wayne State University. The results mark a critical milestone ahead of the company’s planned Investigational New Drug application submission to the US Food and Drug Administration.

The study focused on evaluating the lower limits of detectability for the company’s proprietary MagSense HER2 Imaging Agent. The findings confirmed that a lower dose than previously used in Phase 1 is likely to be detectable in clinical settings. This supports a stronger safety profile and an improved patient experience, while maintaining imaging sensitivity.

Additionally, the study validated the use of optimised MRI imaging sequences developed in conjunction with Wayne State, which outperformed those used in the earlier Phase 1 trial. These sequences will form the basis of imaging protocols for the planned Phase 2 study.

A third outcome of the collaboration was the successful demonstration of how combining molecular imaging with quantitative imaging protocols may enable generation of AI-ready data, potentially enhancing diagnostic accuracy and accessibility in the future.

Imagion also confirmed that production of a new batch of the MagSense HER2 Imaging Agent has been completed. Analytical testing is underway in accordance with FDA guidance, and the product is expected to be ready for use in the Phase 2 study following regulatory approval.

The company remains on track to submit its IND application before the end of 2025, in line with previously stated timelines. Subject to approval, the Phase 2 clinical trial is expected to commence in the first quarter of 2026.

Imagion Biosystems is focused on developing MagSense, a proprietary magnetic nanoparticle technology aimed at improving the precision and safety of cancer detection. The HER2 program is part of a broader clinical strategy targeting a range of cancers including breast, prostate and ovarian cancers.

With the latest study complete and regulatory preparations underway, Imagion continues to build momentum toward a pivotal year for its clinical ambitions.