Medical-imaging company Imagion Biosystems Lodges IND with FDA for Phase 2 Trial of MagSense® HER2 targeted imaging agent

MELBOURNE, Australia–(BUSINESS WIRE)–$IBX #FDA–Imagion Biosystems, Ltd. (ASX: IBX) announced that the company has lodged an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its MagSense® targeted imaging agent. Following FDA approval, the company expects to start a Phase 2 clinical trial with the imaging agent for the detection of nodal metastases in HER2+ breast cancer patients.

“I am thrilled to announce this milestone to the market and am especially proud of our entire team for delivering a quality submission we can feel confident submitting to the FDA,” said Imagion Biosystems President Ward Detwiler. “This is a crucial step in our mission to enable first-class molecular imaging and address a major unmet need in cancer detection.”

MagSense® is a first-of-its-class molecular MRI (mMRI) platform technology that uses iron oxide nanoparticles with custom moieties (e.g., antibodies) to target specific disease biomarkers. Unlike general purpose contrast agents, MagSense® particles are only detected when and where cancer is present. Using MRI, the presence of iron oxide produces a significant, identifiable change in image contrast, empowering clinicians with better information for diagnosis and treatment planning.

“We see this as a game-changing technology for radiologists and oncologists who need to make decisions with precision and certainty,” said Detwiler. “Earlier, more accurate cancer detection is just over the horizon.”

Based on historical FDA review timelines, the company anticipates enrollment for the Phase 2 trial could begin as early as Q1 2026. The company has selected and engaged all required strategic trial partners to manage the study and has begun the process of clinical study site engagement and progressing study logistics in compliance with Good Clinical Practices.

About Imagion Biosystems, Ltd.

Imagion Biosystems (ASX: IBX) is a clinical-stage, medical imaging company dedicated to transforming how cancer is diagnosed and treated. The company produced and is developing clinical applications for MagSense®, a first-of-its-class MRI imaging agent that enables clinicians to detect cancer earlier and with greater precision. Advancing molecular MRI, the company is using non-radioactive, biosafe magnetic nanoparticles to improve diagnostic certainty for a broad range of applications, including HER2+ breast cancer, prostate cancers and ovarian cancers. For more information, visit imagionbiosystems.com.

Contacts

Media Contact
Erich Boileau, Boileau & Co.
imagionbio@boileau.co
US: +1 (616) 786-4461