Imagion Biosystems, Ltd. (ASX: IBX) has announced that the US Food and Drug Administration (FDA) completed its review of the company’s investigational new drug (IND) application, issuing a “Study May Proceed” letter for Phase 1b/2 clinical trials of the MagSense® Imaging Agent in HER2+ breast cancer.

MagSense® is a first-of-its-class molecular MRI (mMRI) imaging agent that uses non-radioactive, bio-safe nanoparticles to help clinicians detect cancer earlier and with greater precision. Phase 1b/2 will be a combined trial designed to confirm the safety profile (Phase 1b) and evaluate efficacy in detecting nodal metastases (Phase 2) in patients with HER2+ breast cancer.

“This is a major win for our team and partners and an important milestone for the company. Molecular MRI could be a true breakthrough in medical imaging,” said Imagion Biosystems President Ward Detwiler. “We are one step closer to helping the many patients battling HER2+ breast cancer.”

Dr. Mohammad Eghtedari, section chief of Women's Imaging at City of Hope Cancer Center in Los Angeles, will serve as the trial’s principal investigator (PI). A recognized expert in diagnostic radiology, Eghtedari previously participated as an independent reviewer of MagSense® in the company’s Phase I trial.

The company expects the trial to yield insights into the potential impact on cost of care, patient outcomes, and clinical value. Paired with quantitative imaging techniques, the trial may produce critical training data for AI diagnostic tools.

Conventional imaging can identify regions of interest using anatomical or morphological features, but without molecular specificity, cannot reliably differentiate benign from malignant tumors. MagSense® uses targeted nanoparticles to increase imaging specificity, making it easier for clinicians to make diagnoses with certainty. The platform technology’s applications extend beyond breast cancer—Imagion has conducted pre-clinical studies of two additional imaging agents that target prostate and ovarian cancers, which will be prepared for IND-enabling studies.

About Imagion Biosystems

Imagion Biosystems is a clinical-stage imaging company pioneering a new category of MRI technology that changes suspicion into certainty. The company has developed and is advancing 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, bio-safe 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.

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“This is a major win for our team and partners and an important milestone for the company. Molecular MRI could be a true breakthrough in medical imaging,” said Ward Detwiler. “We are one step closer to helping the patients battling HER2+ breast cancer."