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ANGLE’s Parsortix liquid biopsy proving to be more than just a cancer detection device

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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.

The system has also been supported by the results of a study from the University of Southern California (USC), published in the International Journal of Molecular Sciences,which highlighted the “key advantages” of its Parsortix system compared to a standard of care tissue biopsy.

Independent data from researchers at The University of Texas MD Anderson Cancer Center, published in the peer-reviewed journal PLOS ONE, has, according to ANGLE, also provided further evidence that the Parsortix system is able to capture and harvest a variety of CTCs, irrespective of their surface antigens, for downstream molecular analysis.

 

Head and neck cancer

A study by the University of Athens showed its liquid biopsy was superior to a leading antibody approach when it came to harvesting CTCs in people with head and neck cancer.

Researchers drew blood from 50 patients and 18 healthy volunteers. The published data revealed use of the ANGLE technology resulted in much higher CTC harvesting positivity rates, purer samples, and “excellent” RNA quality for molecular analysis.

Parsortix has also been used by researchers in Santiago, Spain, to screen people with head and neck and non-small cell lung cancers.

 

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.

 

Melanoma

Researchers in Western Australia using the Parsortix liquid biopsy system have found another use for the cancer detection device. A team at Edith Cowan University in Perth deployed the technology to monitor people with melanoma and were able to sort them into high risk and low-risk groups.

This has opened the possibility of assessing the prognosis and tailoring the treatment approach “taking into account disease status”, ANGLE investors were told. Parsortix was also shown to be superior to other methods looked at by the Edith Cowan team at picking up the tell-tale signs of cancer assessed.

 

Kidney cancer

A study by Italy’s Istituto Nazionale Tumori di Milano suggested that even the presence of a single circulating tumour cell (CTC) in a blood sample prior to treatment may predict a reduced progression-free survival.

 

Lung cancer

An analysis by the University Medical Centre Hamburg-Eppendorf used Parsortix in the early detection of the spread of lung cancer to the brain, suggesting it could be a viable solution.

Currently, the only way to assess whether the disease has developed in this way is to carry out a “highly invasive” tissue biopsy.

New research from the  Laboratory of Translational Oncology, School of Medicine, University of Crete, also demonstrated the potential of Parsortix to assess whether non-small cell lung cancer (NSCLC) patients will respond to immunotherapy drugs.

 

Advanced prostate cancer

A study conducted at University of Southern California concluded that the liquid biopsy system provides a “straightforward and scalable approach” to analysing and assessing treatment options for men with advanced prostate cancer, while ANGLE believes the workflow could extend to most solid tumour cancer types.

 

How it is doing

In its interim results for the six months to June 30, chairman Garth Selvey said the group is now making “strong progress” towards commercialising its liquid biopsy, restating plans outlined previously after it raised £19.6mln to fund its ambitious blueprint.

The cash injection will be invested to create clinical laboratories in the US and UK and to underwrite the development of a pharma service business that will tap into the huge market potential of its Parsortix technology.

The fundraising followed news in October that the US Food and Drug Administration (FDA) is now moving to a “substantive review” of Parsortix after an initial hurdle was quickly negotiated following the initial submission of the company’s data for Parsortix in September.

The regulator’s administrative review is designed to ensure the research group has submitted all the necessary “elements and information” and paves the way for the detailed assessment of ANGLE’s Parsortix system.

The company is seeking Class II De Novo FDA clearance for the cancer detection system and is hoping to receive sign-off for its use in metastatic breast cancer.

Financially, during the first half ANGLE did what most R&D companies are expected to do – it burned cash and made a loss. That first-half loss was flat at £4.8mln.

More importantly, it exited the period with £13.8mln in the bank, and it added a ‘net’ £18.5mln from the fundraising activities.

 

What the chairman says

“After disruption during the period caused by COVID-19 restrictions, the Company adapted and, after the period end, successfully completed the five year programme of work to make the full De Novo FDA submission for Parsortix.  This marked a water-shed moment for ANGLE in its goal to achieve the first ever FDA clearance, the gold standard for medical devices globally, for a system to harvest cancer cells from patient blood for subsequent analysis, initially in metastatic breast cancer”, chairman Garth Selvey said in a statement accompanying the firm’s interim results.

“Following the success of this submission, the Company was delighted by the support from existing and new investors in the fundraising announced on 27 October 2020.  ANGLE now has momentum and is making strong progress towards commercialising its unique liquid biopsy platform to support personalised cancer care.”

“ANGLE is pursuing the opportunity for multiple revenue streams with the establishment of clinically accredited laboratories for running patient samples, development of a pharma services business with a particular focus on immunotherapy, and the design of clinical utility studies to drive adoption of the Parsortix system in clinical practice.”

 

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