Angle Regulatory News (AGL)

ANGLE plc ("the Company")

NEW STUDY DEMONSTRATES POTENTIAL FOR PARSORTIX IN MELANOMA PROGNOSTICATION AND TREATMENT RESPONSE

 Parsortix out-performed alternative systems in head to head comparisons and was selected for molecular analysis in the study

Parsortix CTC score linked to progression-free and overall survival of patients

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that a customer, the Edith Cowan University in Perth, Western Australia has published results of research into the use of ANGLE's Parsortix® system with melanoma patients.

The research shows that the Parsortix system can be used to investigate the heterogeneity of the cancer allowing full molecular analysis of the cancer. The researchers believe this opens the potential for liquid biopsy to be used for prognostication (assessing prognosis) and treatment response monitoring in melanoma.

In a pilot study of 28 melanoma patients, those with circulating tumour cells (CTCs) present in their blood, harvested by Parsortix, had significantly shorter overall survival with a hazard ratio of 7.8x meaning that patients with a positive Parsortix CTC score were 7.8x more likely to die during a 60 week follow-up period than those with a negative CTC score. In clinical use, the stratification of patients into high and low risk groups may allow improved treatment decisions, taking into account disease status.

The research also compared results from the Parsortix system with some competing systems using matched samples and determined that Parsortix yielded the highest recovery of CTCs and had lower white blood cell background. The Parsortix system also did not require pre-processing of the blood whereas the competing systems required a number of pre-processing steps to be undertaken manually to remove red blood cells prior to processing.

The research has been published as a peer-reviewed publication in the British Journal of Cancer and is available at https://angleplc.com/library/publications/.

Elin Gray, Associate Professor, Melanoma Research Group, School of Medical and Health Sciences, Edith Cowan University, Western Australia, commented:

"This work clearly demonstrates the promising clinical utility of the Parsortix system for metastatic melanoma prognostication and monitoring treatment response. We now intend to progress our work with Parsortix to identify ways in which we can improve the treatment of melanoma patients."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"This is another great example of one of our customers developing new pilot studies to show the potential clinical utility of Parsortix in other cancer types and applications. Melanoma is an important opportunity for future use of Parsortix."

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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 an epitope-independent 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 downstream subsequent analyses. CTCs enable the complete picture of a cancer to be seen as 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 system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. 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 study 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 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 27 peer-reviewed publications and numerous publicly available posters, available on our website.