Imagion Biosystems Starts Manufacturing for Phase 2 HER2 Trial, Raises $3.5M to Fuel Growth
Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.
- Manufacturing of MagSense® HER2 imaging agent commenced for Phase 2 trial
- Dr Nina Webster appointed as Non-Executive Director to strengthen board expertise
- AI imaging protocol collaboration underway with Wayne State University and Siemens Healthineers
- IND application preparation progressing with FDA engagement planned for Q4 2025
- Successful $3.5 million fundraising led by CPS Capital to support clinical development
Progressing Towards Phase 2 Clinical Trial
Imagion Biosystems Limited (ASX, IBX) has announced significant progress in advancing its MagSense® HER2 breast cancer diagnostic imaging program. The company has commenced manufacturing of its proprietary MagSense® HER2 imaging agent through a US-based contract manufacturer, marking a critical milestone ahead of the planned Phase 2 clinical trial expected to start by the end of 2025. This manufacturing phase is essential to ensure the imaging agent meets stringent analytical testing requirements, which will support regulatory submissions and clinical use.
Strengthening Leadership with Clinical Expertise
In a strategic move to bolster its leadership team, Imagion appointed Dr Nina Webster as a Non-Executive Director. Dr Webster brings extensive experience in clinical development and biotech commercialisation, which will be invaluable as the company navigates the complexities of clinical trials and regulatory pathways. Her addition signals Imagion’s commitment to maturing its corporate governance alongside its technological advancements.
Innovating Imaging with AI and Industry Partnerships
Imagion has also initiated a collaboration with Wayne State University (WSU) to optimise imaging protocols using artificial intelligence (AI). This partnership, supported by Siemens Healthineers, the global leader in MRI technology, aims to refine the diagnostic capabilities of the MagSense® HER2 agent. The AI-driven imaging protocol optimisation is expected to enhance the precision and utility of molecular MRI scans, potentially setting a new standard for cancer detection. Initial results from this collaboration are anticipated in September 2025 and will be integrated into the company’s upcoming IND application.
Regulatory Engagement and Funding Support
Imagion continues its dialogue with the US Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application, with submission targeted for the fourth quarter of 2025. This regulatory milestone is crucial for commencing the Phase 2 trial. To underpin these developments, the company successfully raised $3.5 million in August 2025, led by CPS Capital. The fundraising proceeds will support manufacturing, clinical trial preparation, and ongoing research activities, with settlement expected following shareholder approval later this month.
Looking Ahead
Imagion’s progress reflects a well-orchestrated approach to advancing its innovative cancer imaging technology from early development to clinical validation. The integration of AI, strategic partnerships, and strengthened leadership positions the company to potentially transform breast cancer diagnostics. However, the coming months will be critical as the company finalises manufacturing, submits its IND application, and awaits initial data from its AI collaboration.
Bottom Line?
Imagion’s next steps in regulatory approval and AI-driven imaging could redefine cancer diagnostics, investors will watch closely.
Questions in the middle?
- Will the IND application be submitted on schedule following completion of analytical testing?
- How will the AI imaging protocol results impact the design and outcomes of the Phase 2 trial?
- What commercial partnerships might emerge as the MagSense® technology advances toward market?
