Positive Results Received from WSU on MagSense Dosage
| Stock | Imagion Biosystems Ltd (IBX.ASX) |
|---|---|
| Release Time | 5 Nov 2025, 9:32 a.m. |
| Price Sensitive | Yes |
Positive Results Received from WSU on MagSense Dosage
- Collaboration with Wayne State University delivers positive and encouraging results on HER2 Imaging Agent dosages
- Results will form part of Phase 2 Clinical Trial for IBX HER2 Breast Cancer Investigational New Drug (IND) Submission
- FDA submission of the MagSense Imaging Agent HER2 Breast Cancer IND in Q4 2025 remains on schedule
Imagion Biosystems (ASX: IBX) has received positive and encouraging results from its collaboration with Wayne State University (WSU) on the dosage of its proprietary MagSense HER2 Imaging Agent. The WSU collaboration focused on establishing the lower limits of detectability of the MagSense HER2 Imaging Agent to help determine the optimal dose range for the planned Phase 2 study in HER2 breast cancer patients and to optimize imaging protocols for improved image quality. The results have substantiated that a lower dose of the MagSense HER2 Imaging Agent compared to the Phase 1 study is likely to be detectable, which is an important step for clinical development. Lower doses that still achieve the necessary detection sensitivity are expected to strengthen the product's safety profile and deliver a better care experience for patients. Additionally, the WSU-optimized sequences will serve as the foundation for the imaging procedures deployed in the planned Phase 2 study. The company also believes the use of quantitative imaging protocols in combination with molecular imaging agents may create AI-ready imaging data to improve and democratize diagnostic accuracy. Imagion Biosystems is pleased with the outcomes of the WSU collaboration and is on track to submit the Investigational New Drug (IND) application for the MagSense HER2 Breast Cancer Phase 2 Clinical Trial to the FDA in Q4 2025, with the commencement of the Phase 2 study expected in Q1 2026, subject to FDA approval.
The company is on track to submit the Investigational New Drug (IND) application for the MagSense HER2 Breast Cancer Phase 2 Clinical Trial to the FDA in Q4 2025, with the commencement of the Phase 2 study expected in Q1 2026, subject to FDA approval.