Imagion Biosystems (ASX: IBX) has announced it will expedite the production of a new batch of its MagSense HER2 imaging agent. This decision comes in anticipation of a Phase 2 breast cancer trial scheduled for later this year. Imagion Biosystems is an Australian company focused on improving healthcare through novel medical imaging technology. Their MagSense technology aims to detect cancer and other diseases earlier and more accurately.
The move follows a productive meeting with the US Food and Drug Administration (FDA), during which Imagion provided detailed responses regarding the structure and operation of the planned trial. According to Imagion, the FDA’s written response indicated no issues that would negatively impact the company’s clinical or commercial development plans. Executive chair Bob Proulx noted the clinical team was encouraged by the level of engagement with FDA reviewers, seeing it as a positive sign of the agency’s interest in their work and the potential impact of their technology.
The multi-site, open-label Phase 2 trial is designed to optimise the dose of MagSense HER2 and refine the imaging protocol required to establish diagnostic performance. Dr William Dooley, a surgical oncologist from the University of Oklahoma Health Sciences College of Medicine, will lead the trial. Dr Dooley has extensive experience in breast cancer care and research, including developing the Johns Hopkins Breast Centre.
Dr Dooley expressed enthusiasm for Imagion’s technology, highlighting its potential to image biological responses to pre-surgical treatments. He believes this new approach could be particularly valuable in guiding decision-making and ultimately improving patient outcomes. Imagion anticipates completing the final stages of MagSense manufacturing and testing before the end of September.
