Angle Regulatory News (AGL)

ANGLE plc ("the Company")

LEADING CANCER CENTRE DEMONSTRATES USE OF PARSORTIX IN MELANOMA

Parsortix harvests cancer cells from blood for analysis where cell surface markers systems are limited

CTCs predicted relapse earlier than standard of care imaging

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that leading European cancer centre, University Medical Centre Hamburg-Eppendorf (UKE), Germany has published results of work demonstrating that ANGLE's Parsortix® system can be used as a liquid biopsy to investigate prediction and monitoring of therapy responses for melanoma patients.

Malignant melanoma is the deadliest form of skin cancer, with a global incidence of 290,000 per annum and 970,000 people living with the disease (source Globocan 2018). The disease is highly heterogeneous and the publication states that "reliable biomarkers, which allow the prediction of therapeutic response and/or the development of therapeutic resistance as early as possible, are urgently needed".

The results of the study by UKE have been published in the renowned peer-reviewed medical journal, Cancers. In the research, UKE used Parsortix over a five-year period, with follow-up in some cases for three years, the results showing that Parsortix can harvest circulating tumor cells (CTCs) from some melanoma patients, where other cell surface marker dependent systems are unable to do so.

This development holds the potential to shift current treatment options for melanoma. Analysis of CTCs harvested from melanoma patients opens up the potential for Parsortix's use as a companion diagnostic to select appropriate therapies and regularly monitor patients with melanoma, ensuring any potential relapse is flagged early and patients can receive the best treatment possible. The researchers demonstrated that the presence of CTCs in a patient's blood sample (where in a previous sample they had been absent) indicated relapse earlier than standard of care imaging techniques.

ANGLE's Founder and Chief Executive, Andrew Newland, commented:

"As the deadliest form of skin cancer, there is a clear need for reliable biomarkers in melanoma. Initially, these can be used in drug trials where the detection of likely responders to the drug is essential and a key commercial need for pharma companies. Ultimately there is the potential for routine clinical use as a companion diagnostic in melanoma."

A copy of the Cancers publication is available on ANGLE's website here

https://angleplc.com/library/publications/.

For further information ANGLE:

For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/

Notes for editors

About ANGLE plc www.angleplc.com 

ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected platforms include a circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.

ANGLE's cell separation technology is called the Parsortix® system, and it enables a liquid biopsy (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all types of CTCs as well as CTC clusters in a viable form (alive). CTCs enable the complete picture of a cancer to be seen as being a complete cell they allow DNA, RNA and protein analysis and the live cells harvested can be cultured. The Parsortix technology is the subject of 24 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide. The Parsortix system has a CE Mark in Europe for the indicated use and FDA clearance is in process for the United States with a 400 subject clinical study and associated analytical studies in metastatic breast cancer. ANGLE is seeking to be the first ever FDA cleared CTC harvesting system and only the third ever FDA cleared liquid biopsy test. ANGLE has already undertaken two separate 200 subject clinical studies under a program designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (ROC-AUC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimisation, and is currently in the process of a 200 patient clinical verification study.

ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEADTM Ziplex® platform and is based on a patented flow through array technology. It provides for low cost, highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. A proprietary chemistry approach (the HyCEAD method) allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. The HyCEAD Ziplex system is extremely sensitive and is ideal for measuring gene expression and other markers directly from Parsortix harvests and was used in the ovarian cancer pelvic mass triage test to achieve best in class accuracy (ROC-AUC) of 95.1%.

ANGLE's proprietary technologies can be combined to provide automated, sample-to-answer results in both centralised laboratory and point-of-use cartridge formats.

ANGLE has established formal collaborations with world-class cancer centres and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 26 peer-reviewed publications and numerous publicly available posters, available on our website.