Imagion Biosystems has received FDA fast-track approval for its MagSense HER2 imaging agent, marking a significant milestone in the company's development of advanced breast cancer diagnostic technology. The approval comes following productive discussions with the US Food and Drug Administration regarding the company's planned Phase 2 clinical trial.
FDA Engagement and Approval Process
The FDA's written response confirmed no issues that could negatively impact Imagion's future clinical and commercial development. Executive Chair Bob Proulx expressed satisfaction with the regulatory engagement, noting the encouraging level of interaction with FDA reviewers.
"Our clinical team was pleased and very encouraged with the level of engagement we had with the [FDA] reviewers," 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."
The company has received formal written feedback from the FDA that included positive feedback and constructive input regarding the study plan and outcomes. Proulx emphasized the significance of this regulatory milestone: "I'm very pleased with the trajectory of our communications with the FDA. We view the feedback from the FDA as very encouraging and can now confidently press forward with the formal submission and plans for undertaking the Phase 2 clinical study knowing we are in good shape regarding the regulatory path."
Phase 2 Trial Design and Leadership
Imagion's multi-site open-label Phase 2 trial will focus on optimizing the dose of MagSense HER2 and establishing the imaging protocol required to determine diagnostic performance. The study will be led by Principal Investigator Dr. William Dooley, a surgical oncologist from the University of Oklahoma Health Sciences College of Medicine.
Dr. Dooley brings extensive expertise to the trial, having developed and directed the Johns Hopkins Breast Centre, which has become an award-winning model for cancer care. 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. His credentials include service on the Commission on Cancer, which sets and monitors national quality standards for cancer care, and membership in multiple professional organizations including the Society of Surgical Oncology and the American Society of Breast Surgeons.
Technology and Clinical Potential
Dr. Dooley praised Imagion's innovative approach to breast cancer detection, highlighting its potential clinical impact. "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."
Manufacturing and Timeline
The company is currently completing the final steps of MagSense manufacturing and testing, with completion expected before the end of September. Imagion plans to file the Investigational New Drug (IND) application for the Phase 2 study in the third quarter of the 2025 calendar year, positioning the company to advance its HER2 breast cancer imaging technology through clinical development.
