Imagion Biosystems

Phase 2 HER2 Clinical Trial Manufacturing Commenced, WSU Imaging Optimisation Program Underway

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 shareholders with a progress update regarding the Company’s business and MagSense® HER2 Breast Cancer diagnostic imaging program, supporting the planned Phase 2 Clinical Trial expected to commence towards the end of 2025.


Highlights:

  • Dr Nina Webster appointed as IBX Non-Executive Director, bringing significant clinical development expertise and corporate experience to the IBX Board ahead of HER2 Breast cancer Phase 2 clinical trial, on schedule to commence by end of 2025
  • Major milestone met with the commencement of the MagSense® HER2 clinical supply manufacturing for the Phase 2 clinical trial
  • IBX, Siemens and Wayne State University (WSU) artificial intelligence Imaging Protocol Optimisation collaboration has commenced
  • Initial results from the WSU led AI Imaging Protocol collaboration anticipated to be received during September 2025
  • The WSU collaboration bolsters the existing agreement the Company has with Siemens Healthineers, the world’s leading manufacturer of MRI equipment
  • Ongoing engagement between FDA and IBX supports planned IND filing H2 2025
  • Funding secured through successful $3.5m fundraising led by CPS Capital in August 2025, settlement to complete late September following shareholder General Meeting

MagSense® HER2 Manufacturing Update – Major Milestone

A significant milestone has been achieved by the Company, with the commencement of manufacturing of the MagSense® HER2 imaging agent by Imagion’s US based contract manufacturer which is expected to be completed by end of September 2025. Analytical testing of the drug product to support use in the planned Phase 2 clinical trial will be completed shortly thereafter.

“Progress towards our IND submission and the Phase 2 clinical trial initiation remains our primary focus,” said Bob Proulx, Imagion Executive Chairman. “Establishing the appropriate manufacturing processes and analytical testing methods are critical in the product development process. If not done correctly at this stage it can delay future trials and regulatory authorisation. By developing robust manufacturing processes now, Imagion can ensure that the appropriate methods are in place and avoid any future delays in the development program as we work towards potential commercialisation.”

IND Update

The Company has continued its formal communications with the US Food and Drug Administration (FDA) following on from the positive feedback in July 2025 regarding its plans to submit an Investigation New Drug (IND) application. Preparation of the IND application is underway with submission anticipated in Q4 2025, subject to completion of the analytical testing by the contract manufacturer.

Dr Nina Webster – New Strategic Board Appointment

As announced on September 1, Dr Nina Webster has joined the IBX Board of Directors as a Non- Executive Director. Nina’s extensive experience in the Australian listed biotech space and successful career in drug development and commercialisation will be a welcome addition to the IBX leadership team as the Company continues to mature and develop the MagSense® technology.

Wayne State University Collaboration – Imaging Protocol Optimisation Commenced

As recently announced, the Company has entered into a collaborative service agreement with MRI experts at Wayne State University (WSU) to develop optimised imaging protocols for use with the MagSense® HER2 imaging agent. The Company is pleased to report that work on the project has already begun and the outcomes are expected to be ready for inclusion in the Company’s IND application.

With the support of Siemens Healthineers, under an existing collaboration agreement Imagion has with the world leader in MRI systems, it is anticipated that the protocols now being developed by WSU will be implemented at each of the clinical sites of the Phase 2 study. The quantitative imaging techniques that have been pioneered by the researchers at WSU could significantly improve the diagnostic utility of the Company’s molecular MRI technology and set the stage for the development of AI diagnostic tools using the Phase 2 study data.


Click here for the full ASX Release

This article includes content from Imagion Biosystems, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

The Conversation (0)
Stethoscope on stacked gold coins, symbolizing healthcare costs or medical finance.

Trump Tariffs to Raise US Medical Device Costs, Hospitals Hold Off on Stockpiling

President Donald Trump’s new round of tariffs —this time targeting copper— has intensified concerns about rising costs across key sectors, including healthcare.

But despite significant price pressures on steel, aluminum, and now copper, all vital to medical device production, there is no indication that US hospitals are stockpiling equipment ahead of expected price hikes, according to recent findings from GlobalData.

Keep reading...Show less
Actinogen

Actinogen confirms 100th participant in XanaMIA phase 2b/3 Alzheimer’s disease trial and interim analysis timeline

Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to announce that the 100th participant in its pivotal XanaMIA phase 2b/3 randomized trial of Xanamem® for Alzheimer’s disease (AD) has now passed all screening tests and is scheduled for randomization and treatment in July. This establishes the timeline for the planned safety and efficacy futility interim analysis by an independent Data Monitoring Committee (DMC).

Keep reading...Show less
Emyria Limited

Medibank to Fund Emyria’s PTSD Program at Perth Clinic

Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) a leader in developing and delivering innovative mental health treatments, is pleased to announce that Medibank Private Limited (“Medibank”), Australia’s largest private health insurer, has commenced funding for eligible customers to access Emyria’s Empax PTSD care program delivered in association with Perth Clinic.

Keep reading...Show less
ASX:HIQ

HITIQ Announces Exclusive Global Agreement with Shock Doctor for PROTEQT Instrumented Mouthguard

Common Shareholder Questions – Entitlement Offer

HITIQ Limited (ASX: HIQ) (HITIQ or the Company), a pioneer in concussion management, proudly announces an exclusive global agreement with Shock Doctor, the world’s leading mouthguard innovator. This landmark agreement marks Shock Doctor’s two-year effort to design a mouthguard that will integrate HITIQ’s PROTEQT technology. The result is a fully developed, market-ready solution that merges HITIQ’s smart sensor technology with Shock Doctor’s unmatched global production partner capabilities.

Keep reading...Show less
HeartSciences Inc

HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis

Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems

Keep reading...Show less
Zoono Group

Exclusive UK Packaging Agreement signed between Sharpak Aylesham Limited, Zoono, and OSY

Zoono Group Limited (Company) (ASX: ZNO) is pleased to update the market on an exclusive contract signed with Sharpak Aylesham Limited (Sharpak) and the Company’s partner in the food supply chain sector, OSY Group Limited (OSY).

Keep reading...Show less

Latest Press Releases

Related News

×