In 2023, cancer is responsible for about three in 10 deaths across Australia. And among women, breast cancer remains the most commonly diagnosed. Over two million women worldwide are diagnosed with breast cancer annually, and approximately 20% of them are diagnosed with HER2+ (human epidermal growth factor receptor 2) breast cancer.

The growing ageing population and the fact that many cancers remain asymptomatic for years have created the need for an early detection solution. 

US-headquartered HealthTech company Imagion Biosystems (ASX: IBX) has been working on the same with its MagSense HER2 Imaging Agent tech for breast cancer. The Company has announced positive outcomes from the IBI10103 phase I clinical trial, which focused on assessing the safety and clinical viability of MagSense® HER2 Imaging Agent (MSH2IA) in conjunction with MRI for evaluating axillary lymph node metastasis in patients with HER2+ primary breast cancer. 

Thirteen women diagnosed with HER2+ breast cancer participated in the trial and were treated with the drug without any reported safety issues, toxicity, or drug-related adverse events.

The trial met its safety goals, showing that, unaware of specific details (i.e. “blinded”), radiologists could differentiate between lymph nodes affected by metastatic HER2+ cancer and those responding normally to the immune system without invasive methods.

Managing Director and CEO of Imagion, Dr. Isaac Bright, who presented the data at the international San Antonio Breast Cancer Symposium, said, “Patients with HER2 positive breast cancer need better staging options that are safe, reliable, comprehensive, and less invasive than today’s standard of care – axillary ultrasound and serial biopsy procedures. 

“Too many of these women endure unnecessary interventions that provide incomplete information and impose unnecessary costs on global healthcare systems. We are encouraged by MSH2IA’s potential to increase the accuracy of disease staging, and thus improve treatment decisions.”

Here’s how the tech works: Patients are given a low-dose injection of MagSense® imaging agent nanoparticles. These nanoparticles attach themselves to tumours, enabling specificity. These attachments are then enhanced during MRI scans, and alas, the nanoparticles are expelled via the liver. 

The IBI10103 clinical trial concluded in October 2023. Conducted as a multicenter open-label study, the trial confirmed the safety and good tolerance of the drug. Blinded radiologists internationally assessed MRI scans before and after administering the drug to patients. 

Unfortunately, five patients’ scans were not interpretable due to image artifacts or tumour invasion preventing lymphatic drainage of MSH2IA to axillary lymph nodes. Among the remaining eight patients, the radiologists identified MSH2IA uptake in both standard and malignant lymph nodes in a comprehensive evaluation.

Tumour-spreading lymph nodes showed uneven, scattered darkening. Notably, after using MSH2IA for imaging, MRI assessments “ achieved parity or outperformed” the standard axillary ultrasound imaging in all eight patients. Molecular MRI with MSH2IA achieved almost perfect agreement at the patient level, as seven out of eight patients identified with tumour-spreading lymph nodes in post-MSH2IA MRI were later confirmed by pathology analysis to have metastatic disease after surgery.

These positive results hold great promise for the advancement of precise oncology care. As the Company advances its breast cancer detection solution, it has also entered into a strategic partnership with Prestige Biopharma to develop an early pancreatic cancer diagnosis platform. It is also working on ovarian cancer detection, and Imagion received a $3.5 million R&D tax incentive from the Australian government.

Currently, Imagion is working on its Investigational New Drug application for submission to the US FDA for its HER2 breast cancer detection tech. Initially planned for Q1 2024, the submission may be delayed as the Company is still gathering adequate resources for advancing the clinical development of MagSense® imaging technology.