Imagion collaboration with Wayne Street University yields positive results

• Wayne State University collaboration delivers initial positive results on HER2 imaging agent dosages
• Results will form part of phase II clinical trial for IBX HER2 breast cancer IND submission with US FDA
• IND submission on schedule for Q4 2025 with final steps of MagSense drug product manufacturing in progress

Special Report: Imagion Biosystems collaboration with Wayne State University (WSU) in the US to establish lower limits of detectability for its proprietary MagSense HER2 Imaging Agent and dose range for the upcoming Phase II study has yielded positive results. 

The collaboration substantiated that a lower dose of the MagSense HER2 imaging agent compared to the Phase I study was likely to be detectable, which Imagion Biosystems (ASX:IBX) said was an important step for clinical development.

Lower doses of the molecular imaging agent technology that still achieve the necessary detection sensitivity are expected to strengthen its safety profile, whilst also delivering a better care experience for patients. 

The collaboration has also established optimised MRI imaging sequences to improve upon those used in the Phase I study.

These optimised sequences will serve as a foundation for the imaging procedures deployed to sites participating in Imagion’s upcoming Phase II clinical trial for its HER2 breast cancer imaging agent.

Furthermore, Imagion said the collaboration substantiated use of quantitative imaging protocols in combination with molecular imaging agents may create AI-ready data to enhance and democratise diagnostic accuracy.

Results to support IND application

Imagion announced in August a collaboration with leading MRI experts Dr Mark Haacke and Dr Sagar Bush at the WSU School of Medicine.

The collaboration further bolsters the existing relationship Imagion has with Siemens Healthineers, the world’s leading manufacturer of MRI equipment.

Both researchers have had a long-standing collaboration with Siemens and are equipped with its top-of-the-line scanners.

Imagion intends to use the results in support of its upcoming Investigational New Drug (IND) application to be submitted with the US Food and Drug Administration (FDA) for its Phase II clinical trial.

Chief business officer Ward Detwiler said Imagion was delighted with the outcomes of the collaboration with WSU.

“Optimised protocols and a better understanding of minimum dosage give us further confidence as we move forward toward our planned IND application this year,” Detwiler said.

“Furthermore, the findings from quantitative MRI techniques that could unlock greater diagnostic precision through AI are extremely encouraging.”

Analytical testing of MagSense agent underway

Imagion recently announced that a new batch of the MagSense HER2 imaging agent had been completed.

It has now confirmed that analytical testing of the agent, in line with FDA guidance, is underway and on track for the results to be completed and included in the IND.

The new batch of the imaging agent will be available for use in the Phase II study following regulatory approval of the IND application.

Based on the current manufacturing of the MagSense HER2 imaging agent and product release timeline, which remains in-line with previous market guidance, the company expects to submit the IND application in Q4 2025.

The Phase II study is subject to FDA approval of the IND and expected to start in Q1 2026.

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.