Imagion Biosystems Gains FDA Fast-Track Approval for MagSense HER2 Breast Cancer Imaging Agent

Imagion Biosystems (ASX: IBX) has announced it will fast-track a new batch of MagSense HER2 imaging agent ahead of a Phase 2 breast cancer trial this year.

The decision follows a meeting with the US Food and Drug Administration where Imagion offered detailed responses on the structure and operation of the planned trial.

The agency’s written response confirmed no issues that could negatively impact Imagion’s future clinical and commercial development.

Encouraging Engagement

“Our clinical team was pleased and very encouraged with the level of engagement we had with the [FDA] reviewers,” executive chair Bob Proulx said.

“We believe the involvement of senior agency staff in the meeting was a sign that the FDA is interested in what we are doing, our Phase 2 plans and the potential impact our technology may have on breast cancer diagnosis and staging.”

Mr Proulx said the final steps of MagSense manufacturing and testing are in progress and that Imagion expects to complete them before the end of September.

Trial Leadership

Imagion’s multi-site open-label Phase 2 trial will look to optimise the dose of MagSense HER2 and the imaging protocol required to establish the diagnostic performance.

Principal investigator and surgical oncologist Dr William Dooley from the University of Oklahoma Health Sciences College of Medicine will lead the trial.

Dr Dooley developed and directed the Johns Hopkins Breast Centre, which has become an award-winning model for cancer care, and he also helped the University of Oklahoma’s Breast Institute become the first of its kind to be certified by the National Accreditation Program for Breast Centres.

Dr Dooley serves on the Commission on Cancer, which sets and monitors national quality standards for cancer care, and is a member of the Society of Surgical Oncology, the American Society of Breast Surgeons, the Fellowship of the American College of Surgeons, and the Society of University Surgeons.

New Approach

Dr Dooley praised Imagion’s breast cancer detection technology.

“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,” he said.

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