Highlights

  • Wayne State University study delivers positive outcomes on MagSense® HER2 dosage optimization.
  • Findings support Imagion’s upcoming FDA submission for Phase 2 clinical trial in Q4 2025.
  • Manufacturing of MagSense® drug product progressing, with IND submission on schedule.

Imagion Biosystems Limited (ASX:IBX) announced encouraging results from its collaboration with Wayne State University (WSU) on MagSense® HER2 imaging agent dosage studies. The program, focused on determining the lower limits of detectability and refining imaging protocols, has yielded results that will contribute to Imagion’s upcoming Phase 2 clinical trial for HER2 breast cancer.

The WSU study confirmed that a lower dose of the MagSense® HER2 imaging agent—compared to that used in Phase 1—is likely to be detectable. This advancement is expected to enhance the product’s safety profile and improve patient experience while maintaining detection sensitivity.

Additionally, WSU’s optimized MRI sequences demonstrated improved imaging performance over those used in the prior trial. These refined protocols will form the basis for imaging procedures in the Phase 2 study. The collaboration also highlighted that quantitative imaging combined with molecular imaging agents could generate AI-ready data, potentially improving diagnostic precision.

“We are delighted with the outcomes of the collaboration with Wayne State. Optimised protocols and a better understanding of minimum dosage give us further confidence as we move forward toward our planned IND application this year,” said Chief Business Officer Ward Detwiler. “Furthermore, the findings from quantitative MRI techniques that could unlock greater diagnostic precision through AI are extremely encouraging.”

Manufacturing Progress and IND Submission Timeline

The company confirmed that production of a new batch of the MagSense® HER2 Imaging Agent has been completed, and analytical testing—conducted in line with FDA requirements—is in progress. The testing results are expected to be finalized and included in the Investigational New Drug (IND) submission.

Following regulatory approval of the IND, the newly produced imaging agent will be used in the Phase 2 clinical trial. Imagion stated that the FDA submission for the HER2 breast cancer Phase 2 study remains on track for Q4 2025.

Next Steps Toward Phase 2 Clinical Trial

With the IND submission planned for the current quarter, the company anticipates initiating the Phase 2 clinical study in Q1 2026, pending FDA approval. The trial will further evaluate the safety and efficacy of the MagSense® HER2 imaging agent for early cancer detection.

Share performance of IBX

IBX’s shares traded at AUD 0.025 per share on 05 November 2025, up by 8.69% from its previous close of AUD 0.023.