Imagion receives CSIRO Federal Government grant for prostate cancer project
Innovations Connections is a Federal Government funding program delivered by the CSIRO aimed to facilitate connecting industry with researchers to help fast-track R&D projects. The $50,000 grant will be used to help support a preclinical research project between Imagion and researchers at Monash University’s Biomedicine Discovery Institute with the aim of achieving an early proof of concept validation of a MagSense™ prostate cancer imaging agent.
“This collaboration with Monash, assisted by funding from CSIRO, helps jump start our prostate cancer project by leveraging the expertise at Monash University and provides a key opportunity to advance our MagSense technology for another important cancer indication,” said Bob Proulx, Executive Chairman of Imagion Biosystems. “We’re grateful for the support from the Australian Government through the Entrepreneurs’ Program
Follow the link below to ANZCTR for full details.
Here is the main trial summary:
This study will assess the safety and effectiveness of an investigational agent (MSH2TR) used to detect lymph node spread of cancer in patients with a specific type of breast cancer, HER2-positive breast cancer.
Who is it for?
You may be eligible for this study if you are a female aged 18 or older, you have histologically confirmed HER2-positive primary breast cancer which you haven't had any prior treatment for (including surgery, radiotherapy, or systemic treatment) and you are scheduled for surgical intervention with lymph node detection by a specific diagnostic agent injection procedure being part of the surgical plan, or scheduled for a core biopsy of a lymph node that is clinically suspicious.
All enrolled participants will receive a subareolar (the pigmented area around the nipple) injection of the investigational agent after a baseline magnetic resonance imaging (MRI) scan on Day 1. The scan will last approximately 45 minutes. Participants will return for another MRI in 24 hours (Day 2) and on Day 4 to detect the lymph node spread. Also on Day 4, participants will have a tissue sample (biopsy) taken from a cancerous lymph nodes for further examination. The biopsy will be investigated for standard of care as well as a new imaging technique called magnetic relaxometry (MRX). As this study is investigating the safety of the investigational agent, participants will be asked to attend a series of seven (7) clinic visits where they will provide up to three (3) blood and urine samples.
It is hoped this research will demonstrate that a single dose of MSH2TR is safe and well tolerated. It is also hoped that MSH2TR is an effective method for detecting HER-2 positive breast cancer that has spread to lymph nodes using MRI and MRX.
First-in-human study update: Study open for enrolment
MELBOURNE — Imagion Biosystems Limited (ASX: IBX), a company dedicated to improving healthcare through the earlier detection of cancer, is pleased to announce that Monash Health has been established as the first clinical site and is ready to commence enrolment of patients for the MagSense™ HER2 breast cancer Phase I first-in-human study.
Dr Jane Fox, the current Director of Breast Services at Monash Health, which encompasses breast surgery and the Monash BreastScreen program, has been named as the Principal Investigator of the MagSense™ study. Dr Fox is also a senior lecturer in the Monash University Department of Surgery and a senior leader of the multi-disciplinary team at the Monash Cancer Centre which includes medical imaging, medical oncology and radiation oncology.
Bob Proulx, Executive Chairman of Imagion Biosystems said, “We are delighted to be working with a leading healthcare organization and with Dr. Jane Fox, a highly regarded clinician who has dedicated her career to improving outcomes for patients with breast cancer and who is strongly supportive of the trial. After all the diligence and hard work, it is extremely exciting to be initiating our first clinical study.”
Imagion Biosystems appoints Geoff Hollis as CFO
MELBOURNE — Imagion Biosystems Limited (ASX: IBX), a company dedicated to improving healthcare through the earlier detection of cancer, has appointed Geoff Hollis as Chief Financial Officer. The appointment strengthens the Company’s management and leadership team as the Company moves into its next phase of growth to develop and commercialize its medical device technology to non-invasively detect cancer. Geoff, based in Melbourne, takes up his position as Imagion CFO on 1 December 2020. Geoff has served as the Chief Financial Officer for multiple ASX listed companies, including Lifestyle Communities where he played a key role in cash management and financing to facilitate rapid growth, reaching the ASX300 and creating significant shareholder value. Geoff’s career in finance began with 10 years at Pitcher Partners a top ten national accounting and financial advisory firm. Imagion’s executive chairman and CEO, Bob Proulx, said Geoff is a welcome addition to Imagion’s executive management team. Being based in Australia, Geoff will be well positioned to assist with the Company’s developing business interests in Australia and will be closer to the Company’s investors and the capital markets to facilitate investor relations. “We look forward to having Geoff aboard as the Company moves through its next growth phase and as we plan to advance the business beyond our upcoming MagSense™ HER2 Phase I study for metastatic breast cancer,” Mr Proulx said. “Geoff has had great experience in corporate transformation, growth strategies, capital raising, capital management, attracting institutional investors and general investor relations. We expect that will be of significant benefit to Imagion as we enter an exciting phase of our business and work to maximise shareholder value.”
Imagion announces HREC approval for Phase I study
MELBOURNE — Imagion Biosystems (ASX: IBX), a company dedicated to improving healthcare through the earlier detection of cancer, is pleased to report that it has received approval from the Human Research Ethics Committee (HREC) for the MagSense™ HER2 Phase I study for metastatic breast cancer. With the study now approved the Company can proceed with finalising contracts with individual study sites.
Additionally, the Company reports that manufacturing of the MagSense™ HER2 nanoparticle formulation for the study remains on track, having successfully completed bulk batch production. The company expects to complete the final step of Good Manufacturing Practice (GMP) compliant packaging of the material on time to support the start of the study.
Imagion Biosystems Executive Chairman Bob Proulx said, “We are very pleased with our progress and will now be working diligently with our planned study sites to commence the study this calendar quarter as we have previously advised
Imagion Biosystems Limited - ASX Small & Mid Cap Conference
A quick 10minute video details the company profile and status
Was recently released by the ASX
I'm not super keen on Imagion's long term prospects. Their core technology of attaching the nanoparticle to a specific genetic 'tag' is not particularly unique. We already attach radioactive isotopes and dyes to a variety of 'tags'. Imagion has to first prove that their new nanoparticle is safe and effective and subsequently prove that it is BETTER than the existing technologies which are cheap and already installed in hospitals around the world.
The biggest benefit is a lack of ionising radiation. The risk of exposure to radiation is causing a cancer (usually with a lead time of 20+ years for solid cancers), and in patients who already HAVE a proven cancer the point is kind of moot, especially since many cancers occur in people old enough that a 20+ year lead time becomes less of an issue. The radiation dose in most of the imaging we use is really minimal and advances in processing power and physics is continually driving radiation doses down. Furthermore often we treat cancers with additional radiation. So a minimal reduction in radiation dose for a scan when you're potentially going to blast the tumour with radiation at a factor of 100x that dose reduction kind of seems a bit silly.
On top of that the current techniques for things like sentinel node detection or PET imaging for cancer are really well studied and already integrated into clinical practice - doctors/services would have to learn the ins and outs of Imagion's technology and forget the old stuff (or maintain both simultaneously).
For example their trial in Her2 positive breast cancer (basically a type of breast cancer that expresses a specific 'tag' or genetic marker) would only be applicable to that subtype of breast cancer, services would have to maintain Imagion's new product/scanner as well as their existing infrastructure too.
Not to say that this doesn't have promise, I'm just not sure the time horizon is that rosy. Also doesn't mean that the hype machine won't lead to material gains either... (P.S. I'm a Radiologist)
IBX's half year results came out yesterday. The strength of their balance sheet with the recent influx of cash was the main takeaway.
I got into IBX and their options at 2.2c AUD and with the recent growth in awareness their share price is nudging 10c daily.
The back half of this year holds prospects of good news that could surge the share price higher. I'm feeling very hopeful, having made 5x with no earth shattering "news", once their first in-human trial is complete, if successful I'd imagine they'll be far north of 10c.
Appendix 4D and Half Year Results H1 2020
Highlights • Significant advancements towards initiating first-in-human study, on track to commence in Q4
• Balance sheet strengthened by $2.5 million through an oversubscribed Rights Issue and shortfall placement
• $2.2 million R&D tax rebate received for 2019 fiscal year
• Subsequent to close of H1 $5 million in proceeds received from oversubscribed placement in July and $1.29 million received from options exercised
• Pro forma cash position improved to $10.2 million as of 18 August 2020
Imagion is starting to get some media attention with it's recent run, here is an article from Stockhead that explains it's tech well......
A University of Sydney study shows Imagion’s iron oxide nanoparticles enable low-field magnetic resonance imaging (MRI) that is powered at a lower Tesla (T) which is a measurement of magnetic flux density.
This may allow the company to offer medical imaging for considerably cheaper rates than available today.
You don’t really need 7T
MRIs over the years have been getting bigger and more powerful with some machines now using magnetic fields of 7T. Normal clinical MRIs are 1.5T or 3T.
This level of high-field imaging is faster and can pick up more details, but at a cost of about $1m/T, it’s also very expensive. The issue to date with low-field imaging has been their inability to deliver high-contrast images without compromising sensitivity.
But prototype MRIs that operate at or under 0.3T are being built which, the Sydney researchers say, “are uniquely positioned to reduce the cost and expand the clinical accessibility of MRI”.
US-based CEO Bob Proulx said the paper showed the Imagion particles work at 6.5mT, or 6.5 milli-Tesla which “according to Wikipedia is about the strength of a refrigerator magnet”.
“That is why the work just published refers to Ultra-Low Field MRI (ULF MRI), because it is at a magnetic field well below current clinical standards,” he told Stockhead.
“The magnets needed for these ULF MRI systems are both less expensive and weigh a lot less which is what make them attractive for a variety of new clinical settings.”
Lead author Dr David Waddington, and colleagues from the University of Sydney, are investigating different nanoparticles as contrast agents for MRIs, and Imagion is providing in-kind support.
Imagion says its nanoparticles — a key element of its proposed imaging device — can provide better contrast in an ultra-low-field MRI than existing agents such as gadolinium, which it says has also come under fire recently for causing neuro- and nephro- (kidney) toxicity.
Prepping for phase 1
Imagion is preparing for a phase one multi-site study in Australia in the December quarter this year of its MagSense test on HER2 metastatic breast cancer. The test aims to eliminate unnecessary surgeries and associated morbidity that results from the current standard of care for biopsy procedures.
Proulx said they’d switched the trial site to Australia after finding a work-around that meant they didn’t need to build and ship multiple versions of their medical device here, and to take advantage of Australia’s more streamlined trial system over those in the US.
The powerful US Food and Drug Administration gave the company breakthrough device designation early last year, which means it can get a priority review and potentially hasten its path to market.
To get this designation the FDA says products must “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions”.
If Imagion’s study proves its device can identify breast cancer tumours without a biopsy, the company plans to move on to other cancers, such as difficult to diagnose ovarian cancer.
This is an interesting company. They are proposing to develop a new biomedical imaging technology that uses magnetic nanoparticles that are specifically targeted to a cancer type.
There are two parts to the strategy. The first which they have delivered on to some extent is the synthesis of iron oxide particles coated with a stealth polymer coating and conjugated with antibodies that target breast cancer. The in vitro cell studies for this in breast cancer cell lines looked convincing and the toxicology studies showed low toxicity. I haven't seen any animal work, but they seem to be looking to do some first in human studies this year. Still a long way to go here but a good start. They have sold $300k of the nanoparticles to an Israeli company.
The second aspect is developing the instrumentation that can detect this particles for clinical use. They have partners for instrument development, but the progress and role of each partner is not clear. It is also not clear how far off the clinical instruments are from even getting a prototype. There is a lot of work to do on the instrument side. In theory the instrumentation they are developing is more sensitive, i.e. can detect smaller tumours, but it is not clear what sort of read out/image would be obtained.
They can do the first in human studies using MRI systems, but these particles are not ideal contrast agents for use in MRI. The physics means that particles make images duller (negative contrast) rather than brighter (positive contrast). Positive contrast is easier to pick up. In saying that they do have a partnership with Siemens a major MRI system supplier.
All in all there is potential here, but still lots of work to do to show real clinical efficacy. We are probably talking at least 10 years for their primary aim of developing clinical magnetic relaxometry scanners.
$3.3 Million raised in late November 2019, FDA fast track designation given, toxicology and pre-human results excellent, floated at 20 cents June 2017, Top 20 hold around 75%, only 500 million shares on issue, received $2 million research grant last year, Scientific Advisory Board excellent.