Imagion Biosystems Ltd

Dr. Edward Flynn, a nuclear physicist, who until the late 1990s was a researcher at Los Alamos National Laboratory, originally developed the MagSense technology. In the late 1990s, Dr Flynn founded a company called Senior Scientific to take the development of MagSense technology ahead. This company was acquired by New York-based Manhattan Scientifics in 2011, and it underwent a reverse take over in 2016, whereon the company was named Imagion Biosystems. Imagion Biosystems went public on the ASX in June 2017 after raising A$12m at 20 cents per share. During 2017 and 2018, Imagion worked on further developing the technology from the basic proof-of principle to a state of readiness for moving into clinical testing. By September 2018, Imagion had initiated manufacturing of the first batch of nanoparticles as per GMP standards, which was needed for clinical testing. Imagion commenced pre-clinical safety and toxicology studies for its lead indication in February 2019. Notably, the FDA granted MagSense Breakthrough Device designation in July 2019. Although this is less relevant now considering the transition to using MagSense as an imaging agent, this achievement cannot be forgotten – the designation will help the cause of MagSense when Imagion eventually seeks FDA approval given it will be familiar with the technology. In 2021, Imagion started a phase 1 trial for MagSense technology for detecting HER2 metastatic breast cancer started. In December 2022, the company presented the interim results of its phase 1 study at the San Antonio Breast Cancer Symposium, highlighting the specificity and safety of MagSense® and in February 2023 announced the strategic shift to use of MRI as the detection method. Full results were similarly positive showing that MagSense could distinguish cancerous and non-cancerous cells. Imagion’s goal was a Phase 2 trial. To this end it sought feedback from FDA in relation to its proposed trial design and positive feedback was received. Imagion is awaiting a final green light, having made an IND submission in early 2026. The plan is a Phase 2 trial for HER2 breast cancer which would likely take 18-24 months.