Collaboration supports Phase 2 clinical trial
Imagion Biosystems has announced the renewal and extension of its collaboration agreement with Siemens Healthineers to support the company's Phase 2 clinical trial of the MagSense imaging agent in patients with HER2-positive breast cancer.
According to Imagion Biosystems, the extended agreement follows the recent FDA clearance of the Phase 2 clinical trial and builds on the companies' previous collaboration during the Phase 1 study.
Under the agreement, Siemens Healthineers will provide in-kind expertise and technical support to participating clinical sites. The company will work with Imagion Biosystems, clinical advisors, and investigators to optimize MRI protocols for the trial.
"We are very appreciative of the collaboration with Siemens Healthineers and grateful for their continued interest in the MagSense technology," said company president Ward Detwiler. "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."
Quantitative MRI techniques included in the study
According to Imagion Biosystems, the collaboration will support the implementation of advanced quantitative imaging techniques developed through the company's research collaboration with Wayne State University.
The company stated that these techniques are expected to improve image quality while reducing imaging time, even when using lower doses of the MagSense imaging agent. Imagion Biosystems also noted that it expects the combination of MagSense and quantitative imaging techniques to support the future development of AI-based diagnostic and imaging interpretation tools.
MagSense technology targets molecular MRI
According to Imagion Biosystems, MagSense is a molecular MRI imaging agent designed to improve cancer detection by adding molecular specificity without using radioactivity. The technology uses targeted magnetic nanoparticles that bind to cancer cells and are visualized using MRI.
The company stated that MagSense imaging agents are being developed for three cancer indications. Its lead product has completed a Phase 1 study for detecting nodal metastases in HER2-positive breast cancer and is now advancing into the Phase 1b/2 study. Additional MagSense imaging agents for prostate cancer and ovarian cancer have also been identified and may progress into IND-enabling studies as resources become available.
Phase 1 results and next steps
Imagion Biosystems reported that, during the completed Phase 1 study, a panel of independent radiologists determined that the MagSense HER2 Imaging Agent produced a readily identifiable change in MRI images that differentiated tumor-involved lymph nodes from non-involved nodes.
According to the company, the Phase 1b/2 clinical trial will establish the optimal imaging dose and timing while also evaluating the diagnostic performance of the imaging agent.
Imagion Biosystems stated that entering the Phase 1b/2 study represents an important development for the MagSense program and is expected to generate multiple clinical data outputs as the technology advances toward commercialization.
Source: Imagion Biosystems
