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Changing the Way We Look at Cancer

About Our Most Recent Update & FAQs

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.

PrecisionMRX Nanoparticles
PrecisionMRX Nanoparticles

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

PrecisionMRX Nanoparticles

Large Market

  • 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
PrecisionMRX Nanoparticles

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
PrecisionMRX Nanoparticles

R&D Benefits

  • 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
More to know

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 believe this significantly expands the market opportunity largely because there is a large existing installed base of MRI scanners and trained radiologists throughout the world and the use of contrast agents is well understood. We eliminate the capital expense associated with having to sell a new type of scanner and focus our business on developing and manufacturing the high gross margin consumable.

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 Phasestudy 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.  

By moving to use with MRI we believe we can achieve initiation of the next study sooner because we do not have to wait for development of the MRX technology. We can also expand to have many sites participate since all cancer centers will have access to MRI scanners. 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 study design and image interpretability.
While we have learned a great deal from the Australian Phase I study, we still have much to do determine the true clinical validity and utility of the MagSense® HER2 imaging agent for the detection of nodal disease in HER2-positive breast cancer patients. Dose optimization, improving imaging protocols, and consistent image interpretation – all of this will be necessary to maximize product performance to ensure well differentiated patient benefits are achieved based on a larger number of patients. Therefore, we expect to pursue larger scale studies in the US (and perhaps other jurisdictions) since we can use any hospital/institution that has access to MRI.
We have a strong intellectual property position (patents issued in multiple large market jurisdictions) based on our proprietary magnetic relaxometry technology (MRX). What we have learned from our studies is that our MagSense® nanoparticles work well with both forms of detection, MRI and MRX. We plan to prioritize development and initial commercialization of our nanoparticles for use with MRI as the faster path to market and we will focus on a new generation of magnetic sensors that could enable use of magnetic relaxometry in the doctor’s office.
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.
This means we can now accelerate the development of our other targeted imaging agents for cancers like prostate cancer and ovarian cancer, similarly for use with MRI.  We aim to have multiple MagSense® imaging agents in the clinic in the coming years and believe having a robust pipeline of MR imaging agents will help us attract strategic commercial partners. 
Cancer is a cellular phenomenon not an anatomical one. Therefore, conventional imaging modalities such as MRI, CT, and ultrasound that provide images of the tissues can only identify “regions of interest” based on seeing lesions that look abnormal.  Contrast agents exist for ultrasound, CT, and MRI, but are non-specific and do nothing to improve the molecular specificity of the image. PET tracers have recently been developed to provide molecular targeting, for example PSMA-PET, but PET tracers expose the patient to radioactivity. Additionally, PET tracers have a short circulating half-life and can be difficult to pair with some types of targeting molecules. Imagion’s MagSense® nanoparticles are made from iron oxide and can be paired with a wide range of cancer specific targeting ligands, such as antibodies, peptides and even small molecules.  Furthermore, in addition to the iron oxide core, MagSense particles are made from substances that are either already have well established safety profile from approved products, or naturally occur in and are easily metabolized by the human body.
By shifting the initial use to be with MRI we believe this will improve adoption. MRI is already used to assess a variety of cancers, and radiologists are already familiar with the use of contrast agents.  Therefore, administering a MagSense® imaging agent prior to doing an MRI will be well understood and acceptable especially when the imaging information enhances their ability to interpret the patient’s condition because of the molecular specificity of the imaging agent.

Please make sure to watch a live recording of our webinar covering our shift with a Q&A session. WATCH HERE > 

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Transforming medical imaging for early disease detection

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