Imagion Biosystems Ltd
(ASX:IBX)Share Price and News
About Imagion Biosystems
Imagion Biosystems (Imagion) is an Australian diagnostic imaging technology developer. The company’s MagSense diagnostic imaging technology, is detectable by MRI scanners, and can potentially improve on other imaging modalities
Imagion also sells superparamagnetic iron oxide particles, branded as PrecisionMRX suited for biomedical applications. The FDA granted MagSense a Breakthrough Device designation in July 2019 as part of the Company’s plan to develop a proprietary detection platform. The company is targeting to use its technology for diagnosing multiple oncology indications including HER2 breast cancer, prostate cancer, ovarian cancer and brain cancer.
The MagSense technology is potentially better than other imaging modalities such as PET or non-targeted MRI as it does not involve ionizing radiation, radioactive tracers and does not provide specific detection of the cancer for non-targeted MRI. The technology uses magnetizable iron oxide nanoparticles conjugated to target-specific molecules, such as antibodies where the nanoparticles can be detected using readily available magnetic resonance imaging protocols.
MagSense works as a superior imaging tool because the magnetic property of the bio-safe nanoparticles allows the MRI scanner to detect the nanoparticles with an image pattern that is distinct when the antibody has bound the nanoparticles to its target. Imagion believes that the MagSense technology is more sensitive than CT scans, with tumours smaller than one centimeter potentially able to be detected. The integration of the MagSense imaging agent into mainstream clinical MRI scanners as a part of a standard diagnostic procedure makes the technology more accessible to the health care ecosystem. MagSense also demonstrates the potential of eliminating the standard invasive biopsy procedures.
Imagion Biosystems Company History
Dr. Edward Flynn, a nuclear physicist, who until the late 1990s was a researcher at Los Alamos National Laboratory, originally developed the MagSense technology. In the late 1990s, Dr Flynn founded a company called Senior Scientific to take the development of MagSense technology ahead. This company was acquired by New York-based Manhattan Scientifics in 2011, and it underwent a reverse take over in 2016, whereon the company was named Imagion Biosystems.
Imagion Biosystems went public on the ASX in June 2017 after raising A$12m at 20 cents per share. During 2017 and 2018, Imagion worked on further developing the technology from the basic proof-of principle to a state of readiness for moving into clinical testing. By September 2018, Imagion had initiated manufacturing of the first batch of nanoparticles as per GMP standards, which was needed for clinical testing. Imagion commenced pre-clinical safety and toxicology studies for its lead indication in February 2019. Notably, the FDA granted MagSense Breakthrough Device designation in July 2019. Although this is less relevant now considering the transition to using MagSense as an imaging agent, this achievement cannot be forgotten - the designation will help the cause of MagSense when Imagion eventually seeks FDA approval given it will be familiar with the technology.
In 2021, Imagion started a phase 1 trial for MagSense technology for detecting HER2 metastatic breast cancer started. In December 2022, the company presented the interim results of its phase 1 study at the San Antonio Breast Cancer Symposium, highlighting the specificity and safety of MagSense® and in February 2023 announced the strategic shift to use of MRI as the detection method. Full results were similarly positive showing that MagSense could distinguish cancerous and non-cancerous cells.
Imagion's goal was a Phase 2 trial. To this end it sought feedback from FDA in relation to its proposed trial design and positive feedback was received. Imagion is awaiting a final green light, having made an IND submission in early 2026. The plan is a Phase 2 trial for HER2+ breast cancer which would likely take 18-24 months.
Future Outlook of Imagion Biosystems (ASX:IBX)
Imagion's future hinges on its ability to advance MagSense through the clinic and onto the market, which will depend on successful clinical trial results and getting the green light from regulators. Even assuming a smooth path, it will take a lot of time and money.
Even the current phase of getting an IND for the proposed Phase 2 trial has taken longer than expected. However, it appears things are on track at last.
Nonetheless, Imagion will face challenges particularly in relation to distribution and training of healthcare professionals. Imaging agents can be complex because they often require dedicated hubs, have short shelf-lives or even specialised imaging hardware. MagSense overcomes some of these problems in having a long-shelf life and their ability to be stocked at hospital pharmacies.
There could be potential for the company to be bought out in the future. Companies like Eli Lilly, Bristol Myers Squibb, and AstraZeneca have made high-value deals to secure radiopharma assets, the latter made a $2bn bid for Fusion Pharmaceuticals. Companies in the space are taking steps to preserve their position by buying complementary technologies and manufacturing infrastructure.
Once approved, the company reckons it has a TAM of $2bn, of which $1bn is Prostate Cancer and $500m each for Ovarian Cancer and HER2+ Breast Cancer.
Is Imagion Biosystems (ASX:IBX) a Good Stock to Buy?
Imagion is a fascinating prospect. The promise of its technology is clear, but it's a balance of potential high rewards against the risks, and whether or not it stacks up may come down to your own financial circumstances and risk tolerance.
This being said, investors should consider that MagSense is not a 'never been tried before' drug or unproven medical device. Rather, MagSense is an imaging agent (a contrast media product), a category where the chances of regulatory approval are much higher. There is no longer fundamental technical risk and likely only needs to show non-inferiority to ultrasounds to gain approval as opposed to having to demonstrate superior efficacy.
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Frequently Asked Questions
MagSense is an imaging agent that can help detect cancers (i.e. providing molecular confirmation) and detect them earlier and with higher specificity than conventional imaging.