• Imagion holds positive meeting with senior US FDA staff on planned Phase II clinical trial for HER2 breast cancer
• Company plans to submit investigational new drug application for MagSense HER2 imaging agent in Q3 CY25
• Renowned surgical oncologist Dr William Dooley to be principal investigator for the multi-site, open-label study

Special Report: Imagion Biosystems is on track to start its Phase II clinical trial for HER2 breast cancer and submit an investigational new drug (IND) application after a positive meeting with the US Food and Drug Administration (FDA).

The meeting enabled the FDA to seek detailed responses from Imagion Biosystems (ASX:IBX), while also providing the company with clarification on written feedback regarding the structure and operation of its planned Phase II trial.

Earlier this month, Imagion announced it had received written feedback providing constructive input on its MagSense HER2 imaging agent study, helping to shape the clinical trial design and expected outcomes.

 In the latest meeting, Imagion reported that no issues were identified that could negatively impact its plans with the dialogue including input regarding future clinical and commercial development considerations.

Imagion’s clinical team that attended the FDA meeting was led by executive chairman Bob Proulx, chief business officer Ward Detwiler and medical affairs advisor Dr Susan Harvey.

“Our clinical team was pleased and very encouraged with the level of engagement we had with the reviewers,” Proulx said.

Senior FDA figures take part in call 

As well, IBX management said they were particularly pleased to see “senior Agency staff” from the FDA take part in the call, which they feel is a particularly positive sign for the future of the trial.

“We view the fact that senior agency staff participated on the call as a sign that the agency is interested in what we are doing, our plans for the Phase II trial in the US and the potential impact our technology may have on breast cancer diagnosis and staging,” Proulx said.

Enhancing current diagnostic methods

The MagSense HER2 imaging agent is part of Imagion’s broader proprietary MagSense Imaging platform, which aims to enhance current cancer diagnostic methods – including X-rays, MRI, CT, ultrasound and PE – by offering a more targeted and personalised approach.

The platform uses iron oxide nanoparticles tagged with cancer-specific targeting antibodies, which can be visualised using standard MRI equipment.

HER2-positive metastatic breast cancer is particularly aggressive, with a high risk of recurrence and metastasis, and ~400,000 new cases diagnosed globally each year.

Imagion described its Phase II clinical trial as a critical milestone in the development of the MagSense HER2 imaging agent, which is designed to detect cancer spread to the lymph nodes in patients with HER2-positive breast cancer.

Accurate nodal staging is a key component in the clinical management of breast cancer.

Currently, ultrasound is the most used method but it has diagnostic sensitivity ranging from 49% to 87% and specificity between 55% and 97%.

Given the aggressive nature of HER2-positive disease, Imagion believes a more sensitive and specific imaging solution could provide significant clinical value.

Based on recent communications and feedback from the FDA, Imagion plans to fast-track manufacturing of the MagSense HER2 imaging agent for the Phase II trial.

Final steps of manufacturing and testing are in process and expected to be completed in Q3 2025.

Renowned surgical oncologist to lead trial

This positive outcome of the FDA meeting paves the way for the company to file an IND application for its MagSense HER2 imaging agent for the Phase II study in the third quarter of 2025.

Dr William Dooley, an experienced and renowned surgical oncologist at the University of Oklahoma Health Sciences College of Medicine, will serve as principal investigator for the multi-site, open-label study.

Dooley is board certified by the American Board of Surgery and received his medical degree from Vanderbilt, with surgical training at Johns Hopkins. He undertook oncology training at Oxford and Johns Hopkins.

He developed and directed the award-winning Johns Hopkins Breast Center and later transformed the OU Breast Institute into Oklahoma’s first nationally accredited breast centre.

Recognised internationally for advancing cancer care standards, he serves on the Commission on Cancer and is a member of several leading surgical and oncology societies.

“Throughout my career, I have been involved with numerous clinical trials seeking to bring knowledge of biological responses and resistance to neoadjuvant treatments prior to surgery,” Dooley said.

“This new approach offers the potential ability to image these responses following pre-surgical treatment, which is particularly important for guiding decision making and improving patient outcomes.”

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.