What ANGLE does
ANGLE plc (LON:AGL, OTCQX:ANPCY) is the firm behind Parsortix – a simple blood test which can help doctors spot the signs of cancer at an early stage.
Blood tests – or liquid biopsies as they are known to clinicians – are seen as having important advantages over the tissue samples that are commonly used by hospitals: they are less traumatic, return results quicker and are cheaper.
Parsortix is to different to many of its rivals as, rather than testing for fragments of dead cancer cells, it detects and captures circulating tumour cells (CTCs).
CTCs provide the tell-tale signs of cancer and their capture can allow doctors to more accurately assess treatment options.
This method is seen as more reliable because other tests have shown that fragments of dead cancer cells are present in around a quarter of people over 65 who do not have cancer. CTCs, on the other hand, give a complete picture because they can only be found in people with cancer.
ANGLE is currently working with the US medical regulator with the hopes of getting a green light in the third quarter of in 2020.
Key clinical trial meets objectives
The AIM-listed company is looking to become the first company to receive clearance from the US Food & Drug Administration for a platform that captures and harvests intact CTCs from patient blood for subsequent analysis.
A clinical trial of 400 women with breast cancer met its primary objectives, revealing Parsortix is able to harvest cancer cells from the blood of a significant proportion of metastatic breast cancer patients.
While it also achieved exploratory goals such as being able to “interrogate” patient blood using certain analysis techniques, the FDA has requested analytical study work that ANGLE says it can complete a minimal cost.
Awaiting US regulatory clearance
In late October, ANGLE said it expected the FDA to approve Parsortix in the third quarter of next year following positive results from analytical studies.
The medical tech firm said headline data from these studies, as well as a successful FDA clinical pivotal clinical study, originally announced in May, had been submitted to the FDA with the aim of getting market clearance for Parsortix to be used in metastatic breast cancer patients.
ANGLE has opted to pursue clearance for Parsortix using the De Novo process, an FDA pathway that involves dialogue with the regulator to assess the risk of a product that does not have an equivalent currently on the market. This process is expected to conclude in the first quarter of 2020, with clearance predicted to follow after in Q3.
New potential uses
In early October, the company said Queen Mary University of London had been awarded a European patent over a new and potentially ground-breaking method of cancer prognosis that used the company’s liquid biopsy.
The firm has an option to take ownership of the procedure that is in place until June 2021 that allows it to expand the array of tests offered by Parsortix.
Queen Mary’s approach was to use the ANGLE technology to process blood so megakaryocyte cells could be counted.
There was a strong correlation between the number of these large bone marrow cells and patient survival, researchers found when assessing prostate cancer sufferers.
A previous study by the university in September also concluded that Parsortix had shown potential to outperform current standards of care for the detection and assessment of prostate cancer.
Meanwhile, researchers at the Medical University of Vienna conducted research that showed Parsortix had the potential to help doctors diagnose lung cancer faster and more accurately
Head and neck cancer
Parsortix has also been identified as having “advantages” when treating head and neck cancer patients.
In an assessment carried out by the University of Birmingham, Parsortix was shown to help accurately assess and grade risk and was also able to help doctors decide treatment options.
Specifically, physicians were able to predict responses to certain medications and spot the failures early so a shift could be made to a more appropriate drug likely to give a better response.
The researcher said the device may even be able to guide doctors as to which of their cancer patients might be candidates for the new immunotherapies coming through.
Being a liquid biopsy, repeat samples were able to be taken. Traditional biopsies take tissue, which can often be a painful process, so the option to make multiple follow-ups is limited.
Finally, the Birmingham team found Parsortix overcame some of the limitations encountered by rival antibody-based liquid systems.
Foetal and ovarian testing
Cancer is where Parsortix has been gaining the most traction – with more than 200 of its devices are in use around the world, but the system has also showed promise in harvesting foetal cells, which could help detect abnormalities such as Down’s Syndrome in unborn children.
In the small-scale study, Parsortix was able to distinguish between male and female chromosomes and, in one case, correctly identified trisomy 21, the marker for Down’s.
Parents and doctors are willing to pay a hefty price to ensure the health of their unborn babies, with the non-invasive prenatal testing market estimated to be worth around US$600mln. Analysts expect it to grow to US$1bn a year by 2022.
A pre-study of an ovarian cancer triage test, which combines Parsortix with its sample-to-answer Parsortix HyCEAD Ziplex analysis platform, began a 200-patient clinical verification study began in late August.
Once the new performance data is available and, assuming comparable results to the previous study, ANGLE intends to establish this test as a laboratory developed test in-house and/or with third party laboratories, expecting demand to stem from significantly improved patient outcomes and its lower costs.
Healthy cash balance
In the meantime, ANGLE has an ample amount of cash, finishing its financial year to 30 April with £11mln of cash and then topping this up with a net £16.9mln in June.
Full-year results in July were in line with an earlier trading update, with revenue and grant income up 25% to £853,000, with an adjusted net loss of £8.6mln compared to £7.2mln the previous year.
This reflected clinical study costs for Parsortix and costs associated with the acquisition of Axela’s Ziplex molecular analysis platform the previous year, said broker FinnCap.
FinnCap's analysts retained their target price of 135p, which is based on a risk-adjusted discounted cashflow (DCF) valuation.