Imagion Biosystems Advances Toward Phase 2 Trial With Lower MagSense Dosage Findings

Highlights:

• Imagion Biosystems Limited (ASX: IBX) has identified that a lower dose of its MagSense imaging agent can still be accurately detected, supporting a safer and more comfortable patient experience, at the time of writing.
• Collaboration with Wayne State University produced enhanced MRI imaging protocols and data that may enable AI-assisted diagnostic accuracy in the upcoming Phase 2 trial.
• The company is preparing to submit an IND application to the U.S. FDA by year-end, with a new batch of MagSense currently undergoing final analytical testing for Phase 2 readiness.

At the time of writing, Imagion Biosystems Limited (ASX: IBX) has reported encouraging results from recent dosage evaluation studies for its HER2-positive breast cancer imaging agent, MagSense, supporting plans to proceed to a Phase 2 clinical trial.

Lower Dose Shows Detectability

Imagion, in collaboration with Wayne State University (WSU) in Michigan, conducted studies to determine the minimum effective dose of MagSense required for accurate tumour node detection. The findings suggest that a reduced dosage—lower than what was used in the Phase 1 trial—remains detectable in imaging scans. This outcome is significant, as it may improve the treatment experience for patients by lowering exposure levels while maintaining diagnostic performance.

Enhanced Imaging Protocols Developed

Researchers at WSU refined magnetic resonance imaging (MRI) sequences to improve clarity and detection sensitivity. These optimised imaging protocols will now form the basis of imaging procedures across Phase 2 trial sites. The study also explored quantitative MRI techniques, which could support the development of AI-assisted image analysis tools, potentially enabling greater diagnostic precision and reproducibility across treatment centres.

Next Steps Toward Phase 2

The company plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration later this year to commence the Phase 2 study. Meanwhile, a new batch of MagSense is undergoing analytical testing and is expected to be available for the trial pending regulatory approval.Chief Business Officer Ward Detwiler said the data bolsters confidence: “Improved imaging protocols and clearer dosage understanding provide a strong foundation as we prepare for the next phase of clinical development,” he noted.

Addressing a Critical Clinical Need

HER2-positive breast cancer accounts for up to 20% of global breast cancer diagnoses and is associated with fast progression and higher recurrence risk. Imagion believes MagSense could help clinicians more accurately assess lymph node involvement—an essential factor in treatment planning.

Disclaimer for Kapitales Research

The materials provided by Kapitales Research, including articles, news, data, reports, opinions, images, charts, and videos ("Content"), are intended for personal, non-commercial use only. The primary goal of this Content is to educate and inform readers. This Content is not meant to offer financial advice, nor does it include any recommendation or opinion that should be relied upon for making financial decisions. Certain Content on this platform may be sponsored or unsponsored, but it does not serve as a solicitation or endorsement to buy, sell, or hold any securities, nor does it encourage any specific investment activities. Kapitales Research is not authorized to provide investment advice, and we strongly advise users to seek guidance from a qualified financial professional, such as a financial advisor or stockbroker, before making any investment choices. Kapitales Research disclaims all liability for any direct, indirect, incidental, or consequential damages arising from the use of the Content, which is provided without any warranties. The opinions expressed by contributors or guests are their own and do not necessarily reflect the views of Kapitales Research. Media such as images or music used on this platform are either owned by Kapitales Research, sourced through paid subscriptions, or believed to be in the public domain. We have made reasonable efforts to credit sources where appropriate. Kapitales Research does not claim ownership of any third-party media unless explicitly stated otherwise.

Customer Notice:

Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.

Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com