Imagion Biosystems has released its Annual Report for the year ending 31 December 2022.
2022 Research & Development Highlights:
- March 2022 – MagSense® HER2 Breast Cancer Phase I study interim results reported
- April 2022 – Sponsored Research Agreement executed with researchers as Massachusetts General Hospital
- July 2022 – Research collaboration with University of Sydney related to brain cancer project
- September 2022 – Preclinical research for prostate cancer detection presented at World Molecular Imaging Conference
- December 2022 – Clinical data for first cohort of MagSense® HER2 Breast Cancer Phase I Study reported at breast cancer meeting
- Subsequent to year-end – Company announces shift to detection of MagSense® HER2 imaging agent by MRI to accelerate route to commercialization
2022 Corporate Highlights:
- Cash balance at 31 December 2022 $4.4M
- Received $2.5M R&D tax incentive
- Move to new facility completed, expanding IBX’s internal nanoparticle R&D capabilities and providing additional manufacturing capability to support clinical programs and can be leveraged to generate revenue
The Future of Molecular Imaging
Changing the way we look at cancer
Over the last 50 years, there have been significant improvements in medical imaging technologies largely in the areas of improving sensitivity and image resolution. But there’s still much to be done around providing a non-invasive, non-radioactive, and targeted solution that can make diagnosing cancer better.
Improving the way doctors are able to detect and diagnose cancer is no easy task, but that is Imagion’s main mission. Our MagSense® technology has been designed to be more targeted and sensitive than conventional imaging methods, resulting in more successful treatments and improved patient outcomes.
The MagSense® bio-functional nanoparticles produce a detectable molecular signature that indicates the presence of tumour cells in a patient’s body, rather than simply identifying a “region of interest” or “suspicious lesion”.
Our Phase I study of the MagSense® HER2 breast cancer imaging agent has indicated that our magnetic molecular imaging technology has the potential to change clinical practices because they would be safe and could be incorporated into existing clinical workflows with conventional MRI machines.
CLINICAL AND PRECLINICAL RESEARCH OF MAGSENSE® IMAGING AGENTS
In 2022, we were very pleased to be able to share our progress in the research and development of two of our MagSense® targeted nanoparticle imaging projects – clinical data for our breast cancer product and preclinical data for our prostate cancer initiative. The progress we have reported provides strong support for Imagion to continue the development of its pipeline of MagSense® imaging agents for different types of cancers.
PHASE I HER2 BREAST CANCER CLINICAL TRIAL
Data collected to-date in our HER2 Breast Cancer study has given us the confidence that our targeted nanoparticles are likely to be safe, well-tolerated and able to detect cancer cells in a patient’s lymph nodes.
A blinded review of the images by an independent panel of radiologists has corroborated our findings. The scans show that the contrast created by the MagSense® HER2 imaging agent in nodes highly suspicious for tumour is distinctly different from the contrast seen in non-involved nodes.
The trial remains open for enrolment to provide additional data to inform future study design and evaluate diagnostic performance.
PROSTATE CANCER PRECLINICAL RESEARCH
The Imagion team also presented preclinical data at the World Molecular Imaging Conference related to a MagSense® imaging agent for the detection of like prostate cancer.
The research demonstrated that MagSense® targeted particles accumulate preferentially in tissues expressing Prostate Specific Membrane Antigen (PSMA), similar to how PSMA-PET tracers work. A MagSense® imaging agent would be a bio-safe alternative and would eliminate the need to use radioactivity to diagnose prostate cancer.
LETTER FROM THE CHAIRMAN, Robert Proulx
2022 was a momentous year for our company. It has been especially gratifying to be able to end the year with demonstrable evidence that our clinical study has resulted in a positive outcome and clarity for our development pathway in 2023 and beyond.
Throughout the year, we remained focused on delivering results from our first-of-its-kind investigative study of our novel MagSense® imaging technology. We initiated the Phase I study as the initial proof-of-principle that our targeted nanoparticle technology could non-invasively detect cancer. While enrolment in the HER2 breast cancer study remained challenging in 2022, we were pleased to be able to share the initial safety review in mid-year and by year-end have sufficient data to report that our study objectives were being met. This is a remarkable achievement for our company and has been instrumental in giving us the confidence to move forward.
In 2022, we were also able to make significant progress with our research efforts to build a pipeline of products based on our proprietary nanoparticle technology. In April, we entered into a research agreement with Massachusetts General Hospital to explore the use of IBX’s iron oxide nanoparticles for vascular imaging as an aid in diagnosing and treating cardiovascular diseases. In September, our team presented encouraging data from our preclinical studies using targeted nanoparticles for prostate cancer and we expanded our partnership with Patrys Limited to include the University of Sydney to investigate the use of the MagSense® technology to detect brain cancers. We look forward to reporting our progress on these projects and others in 2023.
Establishing and maintaining these partnerships with leading companies and research institutions is vital in the development of a robust pipeline of products based on our nanoparticle technology, which can support our strategic goals and our mission of transforming how medical imaging can improve patient outcomes.
At the beginning of 2022, we moved into our new R&D and manufacturing facility in San Diego. This move has helped us expand our internal R&D capabilities and provides the additional manufacturing capacity we will need to support our clinical product development and, ultimately, commercial production.
Aided by an AU$2.5 million research and development tax incentive from the Australian Taxation Office (ATO) in respect of the 2021 year we managed our finances to achieve an important outcome for our shareholders without having to raise capital in 2022.
The remarkable work our team and partners did in 2022 has led us to where we are now. We start 2023 with a clear direction for our company: focusing on clinical applications of our nanoparticle imaging agents in conjunction with the readily and widely-available MRI technology. This is an exciting step for our company, eliminating technical risks and bringing us one step closer to commercializing our technology.
I started this letter indicating 2022 was a “momentous” year. It has been, in both the literal sense of being significant and consequential, but also in the sense of our company now having momentum. We believe we have demonstrated the path forward for Imagion and are hopeful you will support us as we look to execute this strategy in the new year, bringing value to our shareholders and realizing our technology’s potential to change the way we look at cancer.
Robert Proulx | Executive Chairman, Imagion Biosystems, Ltd