Imagion Resumes MagSense® Nanoparticle Manufacturing Capabilities

MELBOURNE, Australia--(BUSINESS WIRE)--Imagion Biosystems, Ltd. (ASX: IBX) announced it will resume MagSense® Nanoparticle manufacturing capabilities ahead of its Phase 1b/2 clinical trial and potential commercialization. The company has contracted nanoComposix, a nanoparticle Contract Development and Manufacturing Organization (CDMO). Under the signed agreement, Imagion will provide the proprietary nanoparticle synthesis equipment, software and procedures required for the CDMO to start manufacturing under the company’s direction.

“We’re very pleased to be partnering with nanoComposix,” said company President Ward Detwiler. “The core particles are a key component of our proprietary MagSense® technology and, therefore, essential to the long-term success of our business.”

The Phase 1b/2 trial, which received IND clearance from the U.S. FDA earlier this year, is designed to confirm the safety profile (Phase 1b) and evaluate efficacy in detecting nodal metastases (Phase 2) in patients with HER2+ breast cancer. Each year, approximately 450,000 women receive a HER2+ breast cancer diagnosis globally, and accurate nodal assessment to support early cancer diagnosis represents an unmet need.

Biotechnology companies often choose to partner with a CDMO to avoid fixed costs, secure scalable production, and accelerate the timeline toward product commercialization. Imagion previously partnered with nanoComposix for nanoparticle production to support its Phase 1 trial and the initial material required for its Phase 1b/2 trial. Manufacturing pharmaceutical-grade material under Good Manufacturing Practice (GMP) quality is required to meet the FDA’s requirements.

About MagSense®

Conventional MRI 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 cancer 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.

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.