MagSense milestone moves Imagion closer to phase II breast cancer trial

• Manufacturing completed on Imagion’s MagSense HER2 breast cancer imaging agent for its Phase II clinical trial
• Imagion, Siemens and Wayne Street University AI imaging protocol optimisation collaboration progressing, with results to be included in US FDA IND submission
• Completion of $3.5m placement will support HER2 breast cancer Phase II trial and advance preclinical studies in prostate and ovarian cancer programs

Special Report: Imagion Biosystems has achieved a major milestone in its mission to improve the early detection of cancer, completing manufacturing of its MagSense HER2 breast cancer imaging agent ahead of its planned Phase II clinical trial.

Imagion Biosystems’ (ASX:IBX) contract manufacturer has successfully completed production of the new clinical batch of the MagSense HER2 imaging agent and is now finalising analytical testing ahead of its release for patient use in the Phase II study.

The completion represents a significant step forward for Imagion and its proprietary MagSense technology – a molecular imaging platform designed to improve how cancers are detected and monitored.

The technology aims to provide earlier, and more precise diagnosis compared to conventional imaging methods.

“We are very happy with the recent progress of our contract manufacturer in completing the new batch of the MagSense imaging agent,” said IBX executive chairman Bob Proulx.

“Once testing is complete, we anticipate submitting the IND application, which we believe will be in order based on our previous communications with the FDA.”

Strategic partnerships strengthen program

Adding to its momentum, Imagion’s new collaboration with leading MRI experts at Wayne State University in the US is bolstering its existing agreement with Siemens Healthineers – the world’s leading manufacturer of MRI equipment.

Imagion announced in August a collaborative service agreement with Dr Mark Haacke and Dr Sagar Bush to develop optimised imaging protocols for its MagSense technology.

Both researchers have long collaborated with Siemens and have access to its state-of-the-art scanners.

The research is focusing on developing quantitative MRI sequences compatible with Siemens and other commercially available scanners.

By combining these advanced imaging techniques with MagSense agents, Imagion aims to enable AI-driven image interpretation and deliver more accurate, data-rich insights for cancer detection and patient care.

Based on current timelines, the company anticipates the protocol work to be completed in the coming weeks to support the proposed IND filing in H2 2025.

Fully funded to advance key programs

In September, shareholders approved the second tranche of a $3.5 million capital raise, providing Imagion with the resources to move confidently into the next phase of its development plan.

The funds will support the planned HER2 breast cancer Phase II trial and the advancement of preclinical studies in the company’s prostate and ovarian cancer programs – both key areas where MagSense has shown strong potential.

Key objectives for the HER2 Phase II program include:

• Completion of drug manufacturing of the MagSense imaging agent for the study
• Submission of the investigational new drug (IND) application to the US Food and Drug Administration (FDA)
• Development of new intellectual property around molecular MRI
• Initiation of the clinical trial and completion of the first patient cohort

Listen to more from IBX: Accelerating early detection of cancer

Regulatory pathway on track despite US shutdown

Imagion noted that the current US Federal Government shutdown was not expected to impact the planned IND submission or delay the start of the trial.

The company said it would continue to monitor any protracted closure of the FDA and any future impact on the proposed approval timelines.

Imagion is also investigating alternative pathways in advancing its clinical programs, including the planned Phase II trial, should any extended disruption occur at the FDA.

This article was developed in collaboration with Imagion Biosystems, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.