Imagion Biosystems Advances Precision Cancer Imaging with FDA IND Filing for MagSense® Phase 2 Trial
Imagion Biosystems, a molecular imaging company focused on transforming cancer detection and diagnosis, has announced a significant regulatory milestone with the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its proprietary MagSense® targeted imaging agent. The IND filing represents a critical step forward in the company’s efforts to bring a new class of molecular magnetic resonance imaging (mMRI) technology into clinical practice.
Subject to FDA clearance of the IND, Imagion Biosystems plans to initiate a Phase 2 clinical trial evaluating MagSense® for the detection of nodal metastases in patients with HER2-positive (HER2+) breast cancer. This next-stage clinical study is designed to further assess the safety, imaging performance, and clinical utility of the MagSense® platform in a real-world oncology setting, where accurate staging and early detection of metastatic disease are essential to effective treatment planning.
President of Imagion Biosystems, Ward Detwiler, highlighted the importance of the IND submission for both the company and the broader field of cancer imaging.
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,” Detwiler said. “This is a crucial step in our mission to enable first-class molecular imaging and address a major unmet need in cancer detection.
Addressing a Critical Gap in Cancer Imaging
Accurate detection of cancer metastasis, particularly in lymph nodes, remains one of the most persistent challenges in oncology. In HER2+ breast cancer, determining whether cancer cells have spread beyond the primary tumor site plays a pivotal role in guiding treatment decisions, including surgery, chemotherapy, radiation therapy, and targeted therapies. Current imaging techniques often lack sufficient sensitivity or specificity to reliably detect small or early-stage metastatic deposits, leading to uncertainty in clinical decision-making.
Imagion Biosystems’ MagSense® technology is designed to directly address these limitations by enabling molecular-level imaging using MRI, one of the most widely available and non-invasive imaging modalities in modern medicine. Unlike conventional contrast agents that enhance imaging broadly and non-specifically, MagSense® is engineered to only generate signal changes where targeted cancer biomarkers are present.
A First-of-Its-Kind Molecular MRI Platform
MagSense® is a first-of-its-class molecular MRI (mMRI) platform built on iron oxide nanoparticles that are functionalized with custom targeting moieties, such as antibodies. These targeting agents are designed to bind selectively to specific disease biomarkers, including HER2, which is overexpressed in a significant subset of breast cancers.
When administered to a patient, the MagSense® particles circulate through the body and selectively bind to cancer cells expressing the targeted biomarker. The iron oxide core of the particle produces a pronounced and measurable change in MRI signal where it accumulates, enabling clinicians to visualize cancer presence with high specificity.
This targeted approach stands in contrast to traditional MRI contrast agents, which distribute non-selectively and can obscure subtle disease signals. By only “lighting up” when cancer is present, MagSense® has the potential to significantly reduce false positives and false negatives, offering clinicians clearer, more actionable imaging data.
Empowering Clinicians with Better Information
The ability to visualize cancer at the molecular level using MRI could have far-reaching implications for radiologists, oncologists, and surgeons. Improved confidence in imaging results may lead to more precise staging, better-informed treatment strategies, and potentially fewer unnecessary surgical procedures.
“We see this as a game-changing technology for radiologists and oncologists who need to make decisions with precision and certainty,” Detwiler said. “Earlier, more accurate cancer detection is just over the horizon.”
By enhancing the diagnostic power of MRI without introducing ionizing radiation, MagSense® also aligns with broader healthcare trends focused on patient safety, repeatability, and cost-effective imaging solutions.
Focus on HER2+ Breast Cancer
The planned Phase 2 clinical trial will focus on patients with HER2+ breast cancer, a subtype characterized by overexpression of the human epidermal growth factor receptor 2. HER2+ breast cancer tends to be more aggressive than other forms but has also benefited from significant advances in targeted therapies over the past two decades.
Despite these therapeutic advances, accurate imaging of lymph node involvement remains challenging. The MagSense® HER2-targeted imaging agent is designed to complement existing diagnostic workflows by providing clinicians with more detailed information about the presence and extent of metastatic disease.
The Phase 2 study will build upon earlier clinical work and preclinical data, further evaluating MagSense® performance in detecting nodal metastases and supporting its potential role as a clinical decision-support tool.
Regulatory Progress and Clinical Readiness
Based on historical FDA review timelines for IND applications, Imagion Biosystems anticipates that patient enrollment for the Phase 2 trial could begin as early as the first quarter of 2026, pending regulatory clearance. In preparation for the study, the company has already taken several important operational steps to ensure a smooth trial launch.
Imagion has selected and engaged its required strategic clinical trial partners, including organizations responsible for trial management, regulatory compliance, imaging analysis, and data oversight. The company has also begun the process of engaging clinical study sites and advancing study logistics in accordance with Good Clinical Practice (GCP) standards.
This proactive approach reflects Imagion’s commitment to maintaining high-quality clinical execution while meeting regulatory expectations in the United States.
Vision for MagSense
While the upcoming Phase 2 trial is focused on HER2+ breast cancer, Imagion Biosystems views MagSense® as a versatile platform technology with potential applications across a wide range of cancers and disease biomarkers. By modifying the targeting moiety attached to the iron oxide nanoparticle, the platform could theoretically be adapted to image other cancer types or disease states where specific molecular markers are known.
The company’s long-term vision is to establish molecular MRI as a new standard in precision imaging, expanding the diagnostic capabilities of MRI beyond anatomical visualization to include highly specific molecular information.
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