Angle Regulatory News (AGL)

ANGLE plc ("the Company")

PUBLICATION ON USE OF PARSORTIX IN HEAD AND NECK CANCER

 Opportunity for Parsortix to be used for PD-L1 analysis of CTCs to assess whether patients will benefit from immunotherapies

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that the University of Birmingham has published results of a review of research into the use of circulating tumor cell (CTC) markers in the treatment of head and neck cancer identifying some key benefits of ANGLE's Parsortix® system over other CTC liquid biopsy systems.

The review has been published as a peer-reviewed publication in the journal Cancers and is available at https://angleplc.com/library/publications/.

The review identifies key potential uses of a CTC liquid biopsy to:

·; facilitate accurate patient risk stratification

·; guide treatment selection

·; predict response and identify the failure of treatment early, allowing a timely shift of therapeutic strategy.

Key advantages, over traditional tissue biopsies, include the ability to repeat the investigation at multiple time points and a reduction in overall healthcare costs.

Identified advantages of the Parsortix system, over other CTC liquid biopsy systems, are that it is not antibody-dependent and is able to detect all sub-populations of CTCs as well as CTC clusters. Other liquid biopsy approaches have been shown to have significant limitations in this indication.

A major opportunity identified by the review is the need to detect, through investigation of the harvested CTCs, whether the cancer is PD-L1 (programmed death-ligand 1) positive. PD-L1 is a potential biomarker for immunotherapy, which may indicate likely response to immunotherapy drugs. ANGLE is developing its processes for investigation of CTCs to determine the presence or absence of PD-L1 expression and this work is already well advanced.

Head and neck cancer is the sixth most common cancer worldwide with some 650,000 new patients diagnosed annually resulting in more than 350,000 deaths every year.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"This review of current research clearly identifies the potential for using CTC liquid biopsies to improve treatment of head and neck cancer. We are pleased that key advantages of ANGLE's Parsortix system have been recognised and believe that head and neck cancer is another opportunity for ANGLE, once we have our own clinical laboratory established."

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 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 25 peer-reviewed publications and numerous publicly available posters, available on our website.