Imagion Biosystems (ASX: IBX) has secured firm commitments for AU$3.75 million (US$2.59 million) in new capital following FDA clearance of its IND application for a Phase 2 clinical trial of MagSense, a molecular MRI imaging agent, in HER2+ breast cancer. The company has begun trial activation activities and expects to start patient recruitment later this year.
MagSense uses targeted nanoparticles to add molecular specificity to MRI. While conventional MRI can identify regions of interest based on anatomical features, it cannot reliably differentiate benign from malignant tumors. MagSense aims to close that gap, helping clinicians make cancer diagnoses with greater certainty using non-radioactive, bio-safe magnetic nanoparticles.
“We are very pleased with the strong demand we saw from investors following our milestone achievement of receiving clearance from the FDA for our MagSense imaging to proceed with the clinical trial,” said executive chairman Robert Proulx. “With this kind of shareholder support we can continue to advance our MagSense molecular imaging technology and change how cancer is detected.”
The raise was led by CPS Capital Group in a two-tranche placement, with the second and larger tranche (approximately AU$3.2 million) pending shareholder approval. Beyond breast cancer, Imagion has conducted preclinical studies of imaging agents targeting prostate and ovarian cancers.
The company has also renewed and extended its collaboration with Siemens Healthineers to support the Phase 2 trial. Siemens Healthineers will contribute expertise and technical support to clinical sites, working with Imagion to optimize MRI protocols and implement advanced quantitative imaging techniques developed through the company’s research collaboration with Wayne State University. Those techniques are expected to improve image quality and reduce imaging time even at lower doses of the MagSense agent, and Imagion sees the combination as groundwork for future AI diagnostic and imaging interpretation tools.
“Having the expertise and support of the world’s leading MRI manufacturer not only helps position us for success but also underscores the importance of molecular MRI to the broader diagnostic imaging market,” said company president Ward Detwiler.
