Clinical-stage imaging company Imagion Biosystems (ASX:IBX) has reported encouraging new data from its collaboration with Wayne State University (WSU), supporting plans to progress its proprietary MagSense HER2 imaging agent toward a Phase 2 clinical trial in patients with HER2-positive breast cancer.
MagSense is a first-of-its-class molecular MRI technology that uses bio-safe magnetic nanoparticles to detect cancer with higher precision and without radiation exposure.
The study with WSU focused on establishing the optimal dose range and refining magnetic resonance imaging (MRI) protocols to improve image quality and diagnostic precision. The company stated that the findings confirmed that lower doses of its MagSense HER2 agent are still detectable, a result that could enhance the product’s safety profile and improve the patient experience in future trials.
The collaboration also demonstrated that new MRI sequences developed at WSU outperform those used in the company’s earlier Phase 1 study and will form the foundation for imaging procedures across Phase 2 trial sites. In addition, the use of quantitative imaging protocols has created the potential for AI-ready data that could help democratise diagnostic accuracy and consistency across clinical settings.
“We are delighted with the outcomes of our collaboration with Wayne State,” said Ward Detwiler, Chief Business Officer at Imagion Biosystems. “Optimised protocols and a better understanding of minimum dosage give us further confidence as we move forward toward our planned IND application this year. The findings from quantitative MRI techniques that could unlock greater diagnostic precision through AI are also extremely encouraging.”
Imagion confirmed that manufacturing of a new batch of the MagSense HER2 imaging agent has been completed, with analytical testing now underway in accordance with U.S. FDA guidance. The company expects these data to form part of its Investigational New Drug (IND) application, which remains on track for submission in late 2025. The Phase 2 trial is expected to commence in early 2026, pending regulatory approval.