When it comes to cancer diagnostics, the ‘tried and trusted’ methods are often not the best ones, but merely the techniques clinicians are familiar with.
For the ASX-listed INOVIQ (ASX:IIQ), the field is ripe for disruption and the company is wasting no time progressing its precision diagnostics based on two separate platform technologies – SubB2M and EXO-NET.
“We have a broad diagnostics pipeline in development across a number of indications for cancer,” says INOVIQ chief executive Dr Leearne Hinch.
The first indication slated for near-term commercialisation is breast cancer monitoring, with a product expected to be “market ready” for a partnership with one or more big-name pathology companies by the end of 2023.
An ovarian cancer screening diagnostic is also in sight.
INOVIQ contends that current diagnostic tests need improvement, presenting a clear opportunity to improve both screening of general populations and monitoring of previously diagnosed patients.
INOVIQ was formed from the mid 2020 merger of the ASX-listed BARD1 Life Sciences and Sienna Cancer Diagnostics. In late 2021 the company was renamed INOVIQ, which means ‘intelligent innovation’.
On June 27 this year INOVIQ shares soared more than 40 per cent after the company reported “outstanding” results from its watershed trial of its SubB2M/CA15-3 test, in relation to breast cancer.
Licensed from the University of Adelaide and Griffith University in 2020, SubB2M is an engineered protein that binds to a pan-cancer biomarker called Neu5Gc, a sugar found on cancer cells.
The independent study showed the SubB2M/CA15-3 assay improved the performance of a leading CA15-3 test routinely used for breast cancer monitoring.
Based on 483 blood samples, the study showed an 81 per cent sensitivity (the ability to detect the tumours) and a 93 per cent specificity (avoiding false positive results).
In part, the trial compared SubB2M/CA15-3 with an existing leading CA15-3 test. The false positives for SubB2M were five per cent lower than the commercial test across all cancer stages, while false negatives were 44 per cent lower.
INOVIQ chief scientific officer Dr Greg Rice says there is a clear unmet need for better monitoring of breast cancer treatment response and earlier detection of recurrence.
Now, the company is planning a further study with key opinion leaders (clinicians) in the US using samples collected from women previously diagnosed with breast cancer during and after treatment.
While the SubB2M platform is applicable to multiple solid cancer types, INOVIQ’s near-term commercialisation strategy revolves around advancing the blood-based assay as a monitoring tool for breast and ovarian cancers.
Hinch cites a $US4.2 billion ($6.1 billion) market for breast cancer diagnostics, which recently overtook lung cancer as the most common cancer.
She notes there are 119 million women in the key markets of Europe, the UK, the US and Australia aged between 50-80 and thus eligible for a screening test.
But fewer than 70 per cent of eligible women undergo screening mammograms, often because they are uncomfortable. INOVIQ’s blood test thus could potentially serve as an adjunct to mammography.
Discomfort aside, mammograms are also less effective for women with ‘dense’ breast tissue, as the tumours do not show up well on the imaging.
Hinch says INOVIQ’s commercialisation strategy is initially focused on the US market, with several options available.
The likely gambit is to sell the kits first as a laboratory-developed test, partnering with large pathology groups such as Sonic Healthcare, Quest Diagnostics or Labcorp.
This approach does not require US Food and Drug Administration (FDA) approval, enabling the test to be market ready earlier.
“That means we will have a test with a quality clinical data package that we can hand over to a lab partner to offer tests for sale to the market, potentially by the end of the year” Hinch says.
INOVIQ may later seek FDA marketing approval, either under the 510(k) ‘predicate device’ route, or the de novo path for novel, low-medium risk devices.
Ultimately, a partnering deal could be structured in several ways but they typically include up-front fees, milestones and sales royalties.
With ovarian cancer, INOVIQ is taking a two-pronged approach of developing a simple, cost-effective SubB2M monitoring test for patients already diagnosed or in remission. Called SubB2M/CA125, this test targets the CA125 biomarker overexpressed in ovarian cancers.
The company is also tapping its separate platform EXO-NET as a broader screening tool.
The company expects its SubB2M/CA125 test to complete analytical validation by December 2023 and clinical validation for ovarian cancer monitoring by July 2024.
The EXO-NET based ovarian cancer test is intended for screening of asymptomatic women at high risk because of genetic or other factors.
The EXO-NET platform isolates exosomes, small extracellular vesicles (EVs) described by Hinch as “little balls released from all cells in the body, including healthy and diseased ones.”
“We open up the exosomes, analyse what’s inside and look for informative biomarkers that tell us about the health or disease status of the cells they came from,” she says.
In the case of ovarian cancer, EXO-NET compares exosomes from cancer cells with normal ones. The diseased cells express several biomarkers, which are assessed via an algorithm to detect ovarian cancer earlier and more accurately.
In collaboration with the University of Queensland, INOVIQ is developing an exosome-based ovarian cancer screening test to detect the disease at an early stage.
Meanwhile, EXO-NET is already being used by academics and drug companies as a research tool for capturing exosomes. According to research house MST Access, the exosome research market is expected to reach $US8.7 billion ($12.8 billion) by 2029.
Underscoring the potential, in early July INOVIQ inked a global joint marketing agreement with the Madison, Wisconsin-based Promega Corporation, a global leader in providing innovative products and technical support to the life sciences industry.
The agreement covers the EXO-NET platform and Promega’s vast portfolio of automated nucleic acid extraction reagents and instruments.
Initially for three years, the deal is expected to extend to other exosome-based research products.
“INOVIQ’s portfolio is wide, with its EXO-NET and SubB2M technologies creating substantial new opportunities,” says MST analyst Chris Kallos.
Kallos says while there’s existing diagnostic tests, “ovarian and breast cancers lack an accurate and reliable early blood test detection standard which suggests there is room for new entrants.”
He adds that while INOVIQ had $8.8 million in the bank as at the end of March, the company’s “potential need for funding remains high to complete commercialisation.”
Kallos values INOVIQ shares at $2.31 a share, which implies around three times upside to the current valuation despite the stock’s stellar run post the company-changing breast cancer results.