IBX AGM Business Update
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Released
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Company Announcement
IMAGION BIOSYSTEMS LIMITED
ASX: IBX
29 May 2025
Imagion AGM Business Update
MELBOURNE – Imagion Biosystems (Company, ASX: IBX), a company dedicated to improving
healthcare outcomes through the early detection of cancer, is pleased to provide shareholders
with a general business update in advance of its Annual General Meeting.
As previously noted, the main focus of the company’s business has been the continued
development of the MagSense® HER2 Imaging Agent which is intended to be used in the
assessment of axillary nodal disease in patients diagnosed with HER2+ breast cancer.
Manufacturing of the imaging agent drug is expected to commence in June and be completed
in July, with the company still planning to be filing its Investigational New Drug (IND) application
for a Phase 2 study with the U.S. Food and Drug Administration (FDA) in the third quarter of
2025.
Other key updates associated with the IND milestone include:
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The Company has recently been in communication with the FDA regarding the
planned application and is expecting to receive feedback in mid-July before
making the final submission;
A Principal Investigator for the study has been identified; and
Optimization of the MRI protocols is expected to commence in June in
collaboration with Siemens and experts from Wayne State University.
Commenting on the Company’s progress, Executive Chairman, Bob Proulx said, “Whilst
progressing our business plan in the most cost-effective way, I am very pleased with the
progress we have been making and that we remain on track to advance our MagSense® HER2
product to the next phase of clinical testing. As we have continued to reach out to clinicians
and prospective partners in the imaging markets, it is clear that there is an unmet need and
that our first-of-its-kind molecular MRI technology is addressing a gap that should result in
significant value creation for the company.”
“Whilst the majority of the Company’s business activities have focused on developments of the
HER2 breast cancer program, the company is pleased to report that Dr. Kayat-Bittencourt,
Vice Chair of Innovation at University Hospitals and an Associate Professor of Radiology at
Case Western Reserve University has been engaged as clinical advisor for the Company’s
prostate cancer program. Dr. Kayat-Bittencourt is a leader in the field of prostate cancer
research using multiparametric MRI (mpMRI), with over 45 peer-reviewed publications and
110 conference abstracts. Previously IBX had reported strong preclinical evidence for the
MagSense® PSMA imaging agent that was under development for the detection of prostate
cancer but has limited activities on this product based on funds available.”
“As we approach having the breast cancer program move to Phase 2 clinical trial, we are
anticipating restarting the prostate and ovarian cancer programs. Working with Dr. KayatBittencourt gives us the chance to have input into the clinical development program from one
of the world’s leading prostate cancer imaging experts.”
ENDS
About Imagion Biosystems
Imagion Biosystems is developing a new non-radioactive and precision diagnostic molecular
imaging technology. Combining biotechnology and nanotechnology, the Company aims to detect
cancer and other diseases earlier and with higher specificity than is currently possible.
For more information, visit https://imagionbiosystems.com/investor-hub/
Authorization & Additional information
This announcement was authorized by the Board of Imagion Biosystems Limited.
Media & Investor Relations:
Email: info@imagionbio.com
AU: +61 3 9692 7222
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