Imagion Biosystems Ltd
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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. In March 2023, Imagion received positive feedback from FDA in relation to its proposed phase 2 trial design, based on which the company is planning to conduct a multi-site phase 2 clinical trial in the US. As of June 2024, phase 2 has not yet begun as the company is waiting to be granted Investigational New Drug (IND) approval from the FDA.
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, and the company spent a few months in suspension for lodging its financial reports late.
Is Imagion Biosystems (ASX:IBX) a Good Stock to Buy?
No. Even though its unique approach to cancer diagnosis may appear compelling it's important to note the company is facing financial challenges, including rising losses and the need for more funding to keep the research going. The promise of their technology is clear, but it's a balance of potential rewards against the risks, and it does not stack up in our view.
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Frequently Asked Questions
Imagion uses special MRI technology with safe nanoparticles, offering a more accurate and less invasive way to spot cancer, a major leap forward in diagnosing and caring for patients.