Changing the Way We Look at Cancer
Accelerating our path to commercial product
Our goal has always been to use medical imaging to change clinical practice, eliminate unnecessary biopsies and aid the early detection of cancer.
The data coming out of our Phase 1 clinical trial supports a shift in our strategy to a path that takes risks out of the plan and should accelerate our path to commercialization.
What our data shows
The clinical data obtained in our Phase I MagSense® HER2 imaging agent study indicates our molecularly targeted nanoparticle technology could be effective in helping to detect tumor in the regional lymph nodes of HER2-positive breast cancer patients when used in conjunction with conventional MRI scanners. Leveraging these results, we can now commit to developing our molecular imaging agents for use with MRI scanners as the fastest path to commercialization.
What this means for IBX
The shift to MRI as the detection technology eliminates the costs, risks and time to develop and seek regulatory approval for a new imaging platform. MRI systems are widely available in hospitals around the globe, making it easier to undertake clinical studies, and making market access easier and faster, which should allow us to attract a strategic commercial partner sooner.
Key points of this strategy shift
- Increased market size due to number of existing MRI sites already widespread worldwide
- Total Addressable Market (TAM) of $500M AUD per year in HER2 Breast cancer nodal imaging as a first disease target
Pathway to Commercialization
- Path to market simpler, eliminating the challenges and costs of introducing a new piece of capital equipment
- Cost and time to commercialization reduced
- Improves ease of clinical adoption and subsequent commercial returns
- Pipeline of targeted imaging agents for additional disease classes including prostate and ovarian cancers
- Partnerships to explore the utility of MRX technology for use in doctor’s offices
Technology Update FAQs
Below we have tried to anticipate key questions and address the implications for the Company. We hope these FAQs help.
Magnetic Resonance Imaging (MRI) is a well-known and accepted medical imaging modality. There are more than 30,000 MRI scanners available around the world. By focusing the development of our imaging agents for use with MRI, we avoid the time and costs of developing a new type of imaging system that would have to compete for space and budget in the hospital. By making our imaging agents work with conventional MRI scanners, we anticipate faster commercial introduction and market uptake/acceptance – and a more attractive proposition for strategic commercial partners.
We will face the same risks associated with new product entry in established and entrenched markets where low-cost ultrasound is ubiquitous despite performance limitations. However, we believe introduction for use with MRI will reduce those risks compared to introducing a new technology. We are not aware of other players trying to address the unmet medical need that we are by molecular imaging and hence expect to benefit from being the first mover and potentially obtain regulatory exclusivity in certain jurisdictions if approved first.
We can now say that the primary objectives of the Phase 1 study have been achieved;
i) there have been no safety issue reported related to the imaging agent, and
ii) the imaging agent has demonstrated feasibility to detect cancer by both MRI and MRX.
We consider this to be a significant accomplishment. We plan to keep the current Phase I study open while we proceed with our plans for the next phase of development. Each new patient adds valuable context that can inform new study design and image interpretability.
We expect to be able to maintain the Breakthrough Device designation for our proprietary MRX technology. However, the FDA regulates MRI contrast agents through the imaging group within the Center for Drug Evaluation and Research (CDER). As such we have already begun dialog with the appropriate division of the FDA about our interest in bringing the MagSense HER2 imaging agent forward for use with MRI systems. We do not expect this to materially impact the cost, time, or regulatory requirements for the imaging agent, and it will eliminate the cost and time associated with analytical performance testing of the MRX instrumentation since it will now be used with commercially approved MRI scanners.
Please make sure to join our webinar for a live Q&A session. Register here: https://info.imagionbio.com/fireside-chat-webinar-feb-2023
Or reach the Investor Relations department via email: firstname.lastname@example.org
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