Imagion Biosystems Australia California
07.08.2025 - 17:59:58Imagion Announces Positive Results from IBI10103 Phase I Study Demonstrating Safety and Clinical Feasibility of Molecular MRI with MagSense® HER2 Imaging Agent
About HER2+ Breast Cancer
More than 2 million women worldwide are diagnosed with breast cancer annually, and approximately 20% of them are diagnosed with HER2+ breast cancer. Accurate disease staging is crucial, as treatment strategies vary based on primary tumor characteristics, lymph node status, and more distant metastatic disease. The current clinical standard of care for breast cancer staging relies on clinical assessment and diagnostic imaging. Axillary ultrasound for staging breast cancer is highly subjective and operator-dependent – as many as 50% of breast cancer patients may have their disease inaccurately staged. Inaccuracies at the outset of disease management leave a number of patients inadequately treated and subject others to wasteful and potentially harmful treatments and interventions. Molecular MRI with MSH2IA may emerge as the new standard of care for accurately staging the disease in patients diagnosed with HER2+ breast cancer.
About MagSense® HER2 Imaging Agent
The MagSense® HER2 Imaging Agent features a superparamagnetic iron oxide nanoparticle core synthesized at Imagion's GMP-compliant facility in San Diego, CA. It is coated with biocompatible polymers and functionalized with the monoclonal antibody trastuzumab or Herceptin®. MSH2IA is designed to be a single dose injected near the primary tumor and has been proven to drain through lymphatics, specifically targeting and binding to HER2+ breast cancer cells.
About Imagion Biosystems
Established in 2017 and headquartered in the San Diego, California, US, Imagion Biosystems is an ASX-listed company dedicated to developing innovative medical imaging technologies for various cancer types. Imagion Biosystems is advancing clinical development of its MagSense® platform technology to revolutionize cancer diagnosis, introducing molecular imaging to MRI. The Company's lead program has demonstrated its innovative technology embodied in MagSense® HER2 Imaging Agent (MSH2IA) is safe and well-tolerated in patients diagnosed with HER2+ breast cancer. Imagion Biosystems' MagSense® pipeline includes prostate cancer, ovarian cancer, pancreatic cancer, and brain cancer programs.
For more information, visit https://imagionbiosystems.com
Authorisation & Additional information
This announcement was authorised by the Disclosure Committee of Imagion Biosystems Limited.
Australian Media & Investor Relations:
Geoff Hollis, CFO and Company Secretary
geoff.hollis@imagionbio.com
+61 438 168 008
U.S. Media Contact
Casie Ost
casie.ost@imagionbio.com
+1-619-693-4428
Video - https://mma.prnewswire.com/media/2299580/Phase_I_Study_update_with_MagSense_HER2_Imaging_Agent.mp4
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