Imagion set to improve cancer detection through molecular MRI

Imagion Biosystems to use funds from $3m capital raise to advance MagSense platform technology
Through MagSense, Imagion aims to revolutionise cancer diagnosis by introducing molecular imaging to MRI
The company is pursuing initial indication in HER2+ breast cancer staging, with pipeline candidates for prostate and ovarian cancers

Special Report: Imagion Biosystems will use funds from its recent $3m capital raising to advance its revolutionary cancer-diagnosis MagSense platform towards commercialisation.

Imagion Biosystems’ (ASX:IBX) chief business officer Ward Detwiler said IBX’s proceeds from the capital raise would help achieve key milestones in 2025, including prioritising phase II clinical studies of MagSense in its first indication of HER2+ breast cancer and advancing two additional pipeline products in prostate and ovarian cancers.

It’s a well-known fact, backed up by the World Health Organization, that cancer is a leading cause of death globally. However, cancer mortality is reduced when cases are detected and treated early including through early diagnosis and screening programs.

Detwiler said MagSense improved on current techniques for cancer diagnosis such as X-Rays, magnetic resonance imaging (MRI), computed tomography (CT), ultrasounds and positron emission tomography (PET) by providing a more specific and personalised approach.

The MagSense imaging platform involves the use of iron oxide nanoparticles labelled with cancer-specific targeting antibodies, which can then be imaged with the widely available MRI.

Imagion’s lead imaging agent is targeting diagnosis of metastatic HER2+ breast cancer, a form cancer known to be highly aggressive.

“This study not only advances us one step closer to bringing MagSense to a large patient population in need, but also acts as a proof of concept which allows us to address a range of other cancers.”

Positive phase I study

The company has completed a phase I study (IBI010103), involving 13 HER2+ breast cancer patients at four Australian sites.

The results of that study were released in December 2023, which included:

The molecularly targeted MRI contrast agent MSH2IA (MagSense HER2 Imaging agent) was safe and well tolerated, with no adverse or serious adverse events
An independent panel of radiologists confirmed the detectable magnetic signature
The MagSense imaging agent could potentially reduce the need for lymph node biopsies

With funding secured, Imagion will progress with an investigational new drug application to the US FDA for a multi-site phase II study for HER2+ breast cancer in mid-2025.

“We are bringing something that is so much more powerful than the current standard of care allowing more accurate and timely patient diagnosis leading to personalised and appropriate treatments,” Ward said.

Could replace need for biopsy

Imagion’s newly appointed medical advisor Dr Susan Harvey, a breast imaging radiologist by training, said breast cancer was typically diagnosed using ultrasound, mammography and biopsy.

Harvey recently retired as vice president of medical affairs at Hologic, a world-leader in mammography and women’s health.

She previously served as director of breast imaging at the Johns Hopkins School of Medicine and is co-founder of the non-profit organisation Cure Women’s Cancer.

Harvey said these tools are effective, yet not specific, so false positives and false negatives occur.

“MagSense brings precision and specificity to breast cancer imaging,” she said.

“The technology has the promise of fewer false alarms and fewer overlooked cancers.

“Like a pregnancy test that is pink or blue, the MagSense technology could provide an accurate yes or no answer to MRI as to whether cancer is present, and thereby enable a more personalised treatment the woman will receive.

“This innovative tool will transform cancer detection and care, starting with HER2+ breast cancer.”

Potential to target other cancers

Following the capital raise, the company will be ready to recommence the MagSense platform for clinical development in HER2+ breast cancer, and advance other pipeline programs for prostate and ovarian cancers.

“The underlying technology is extendable to any type of cancer for which we have a targeting ligand,” said Detwiler.

“We already have products in the pipeline for HER2+ breast, prostate and ovarian cancers, representing over 7 million patients per year in the US market alone.

Detwiler said expanding to other types of cancer, such as pancreatic, lung, or any other cancer with a known biomarker could follow the same clinical development pathway.

“This will fundamentally change how MRI is used in cancer detection, expanding access and improving outcomes for millions of patients globally,” he said.

This article was developed in collaboration with Imagion Biosystems, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.