Positive Results Received from WSU on MagSense Dosage
Released
Released
Announcement PDF
Imagion Biosystems Limited
ASX: IBX ACN 616 305 027
Suite 2, Level 11 385 Bourke Street Melbourne VIC 3000
http://www.imagionbiosystems.com/ | investor@imagionbio.com
Company Announcement
General
IMAGION BIOSYSTEMS LIMITED
ASX: IBX
5 November 2025
Positive Results Received from WSU on MagSense®
Dosage – Phase 2
Clinical Trial on HER2 Breast Cancer Imaging Agent
FDA Submission of IND for MagSense® HER2 Phase 2 Clinical Trial on Track Q4 2025
Key Highlights:
Wayne State University Collaboration Program Delivers Positive and Encouraging
Results on HER2 Imaging Agent Dosages
Important Milestone Met – WSU Program 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
Final Steps of MagSense® Drug Product Manufacturing in Process
Imagion Biosystems (ASX: IBX) (Company or Imagion), a company dedicated to improving healthcare
outcomes through the early detection of cancer utilising its proprietary MagSense® imaging
technology, is pleased to provide the markets with an update on progress towards the Company’s
planned Phase 2 study for HER2 Breast Cancer.
Positive Initial Results from Wayne State University on MagSense® Imaging Studies
The Wayne State University (WSU) collaboration, which focused on establishing the lower limits of
detectability of the Company’s proprietary MagSense® HER2 Imaging Agent to help establish the dose
range for the planned Phase 2 study in HER 2 breast cancer patients and optimising imaging protocols
for improved image quality, has yielded positive and encouraging results. This is a very important
program with WSU, as the Company intends to use these results in support of its upcoming
Investigational New Drug (IND) application to be submitted with the U.S. Food and Drug
Administration (FDA) for its Phase 2 Clinical Trial.
The WSU/IBX collaboration has substantiated that:
1. A lower dose of the proprietary 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, whilst also delivering a better care experience for patients.
Imagion Biosystems Limited
ASX: IBX ACN 616 305 027
Suite 2, Level 11 385 Bourke Street Melbourne VIC 3000
http://www.imagionbiosystems.com/ | investor@imagionbio.com
Company Announcement
General
2. The WSU-optimised sequences improve upon the MRI sequences used in the Phase 1 study
and will serve as the foundation for the imaging procedures deployed to sites participating in
the planned Phase 2 study.
3. The use of quantitative imaging protocols in combination with molecular imaging agents may
create AI-ready imaging data to improve and democratise diagnostic accuracy.
“We are delighted with the outcomes of the collaboration with Wayne State. Optimised protocols and
a better understanding of minimum dosage give us further confidence as we move forward toward our
planned IND application this year,” said Chief Business Officer Ward Detwiler. “Furthermore, the
findings from quantitative MRI techniques that could unlock greater diagnostic precision through AI
are extremely encouraging.”
MagSense® Manufacturing Progress Update
As previously disclosed, production of a new batch of the MagSense® HER2 Imaging Agent was
completed. The Company is pleased to confirm that analytical testing of the Company’s proprietary
MagSense® agent, in line with FDA guidance, is underway and is on track for the testing results to be
completed and included in the IND. The new batch of the imaging agent will available for use in the
anticipated Phase 2 clinical study following regulatory approval of the IND application.
FDA Submission of IND for HER2 Breat Cancer Phase 2 Clinical Trial Remains on Schedule Q4 2024
Based on the current manufacturing MagSense® HER2 Imaging Agent and product release timeline,
which remains in-line with previous market guidance, the Company expects the planned IND
application to be submitted to the FDA in the current quarter of 2025. Commencement of the Phase
2 study is subject to approval of the IND by the FDA and is expected to start in Q1 2026.
Authorisation & Additional Information
This announcement was authorised by the Board of Imagion Biosystems Limited.
ENDS
About Imagion Biosystems
Imagion Biosystems (ASX: IBX) is a clinical-stage, medical imaging company dedicated to transforming
how cancer is diagnosed and treated. The company produced and is developing 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
https://imagionbiosystems.com.
Imagion Biosystems Limited
ASX: IBX ACN 616 305 027
Suite 2, Level 11 385 Bourke Street Melbourne VIC 3000
http://www.imagionbiosystems.com/ | investor@imagionbio.com
Company Announcement
General
Executive Chairman Contact Details
Bob Proulx
investor@imagionbio.com
AU: +61 3 9692 7222
Media Enquiries & Investor Relations:
Erich Boileau, Boileau & Co.
imagionbio@boileau.co
US : +1 (616) 786-4461
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