Imagion Biosystems is set to submit its Investigational New Drug application for the MagSense® HER2 breast cancer imaging agent in December 2025, paving the way for a Phase 2 clinical trial in early 2026. Collaboration with Wayne State University has refined the trial design, promising improved patient safety and diagnostic precision.
- IND submission for MagSense® HER2 imaging agent scheduled for December 2025
- Phase 2 clinical trial design finalized with Wayne State University collaboration
- Reduced imaging agent dose to enhance patient safety and cost efficiency
- Optimized MRI sequences developed with Siemens Healthineers support
- Strategic US trial partners selected to expedite trial commencement in early 2026
Progress Towards FDA Submission
Imagion Biosystems Limited (ASX, IBX) has announced significant progress in its development of the MagSense® HER2 breast cancer imaging agent, with the company on track to submit its Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) in December 2025. This milestone is a critical step towards initiating a Phase 2 clinical trial aimed at improving early detection and diagnostic accuracy for HER2-positive breast cancer, an aggressive cancer subtype with substantial unmet medical needs.
Collaboration Yields Optimized Trial Design
Central to this advancement is the collaboration with MRI experts at Wayne State University, which has delivered compelling data supporting a refined Phase 2 trial protocol. Notably, the research enabled a reduction of the MagSense® imaging agent dose to one-third of that used in the earlier Phase 1 study. This reduction is expected to enhance patient safety and reduce manufacturing costs, addressing two key considerations for clinical development and eventual commercialisation.
Additionally, Wayne State researchers developed optimized MRI sequences that maintain detection sensitivity while potentially shortening scan times. These improvements could streamline clinical workflows and lower barriers to adoption in routine practice. The imaging protocols will be supported by Siemens Healthineers, a global leader in MRI technology, further strengthening the trial’s technical foundation.
Strategic Partnerships and Trial Readiness
Imagion has also completed a rigorous selection process for strategic trial partners in the United States. These collaborators will manage clinical site identification, participant recruitment, and data oversight, ensuring compliance with Good Clinical Practices. With these partnerships in place, the company is well-positioned to commence the Phase 2 trial in early 2026, pending FDA acceptance of the IND application.
The Phase 2 study is designed in three parts, an initial cohort to gather additional safety data as requested by the FDA, followed by evaluation of the reduced dose and optimized imaging in a second cohort, and finally a larger group to establish diagnostic performance. The trial is expected to run for 18 to 24 months, providing a robust dataset to support further development.
Implications for Cancer Imaging and Beyond
Beyond dose reduction and imaging optimization, the trial incorporates quantitative imaging techniques that could generate AI-ready data. This opens the door for future integration of artificial intelligence diagnostic algorithms, potentially enhancing radiologists’ ability to detect and stage cancer more accurately. If successful, MagSense® could represent a significant leap forward in molecular MRI, offering a non-radioactive, bio-safe alternative for cancer detection.
Executive Chairman Bob Proulx highlighted the importance of these developments, emphasizing the company’s commitment to delivering innovative solutions that address critical healthcare challenges while creating shareholder value.
Bottom Line?
Imagion’s upcoming IND submission and Phase 2 trial launch mark a pivotal moment in advancing safer, smarter cancer imaging.
Questions in the middle?
- Will the FDA accept the IND application without additional data requests?
- How will the reduced imaging agent dose impact diagnostic accuracy in diverse patient populations?
- What timelines and milestones should investors watch for during the Phase 2 trial?