Angle Regulatory News (AGL)

ANGLE plc ("the Company")

PARSORTIX PERFORMANCE DEMONSTRATED IN HEAD AND NECK CANCER

Molecular analysis demonstrates measurement of key cancer genes and methylation status from a simple blood test

Direct comparison highlights key advantages of Parsortix compared to antibody-based approach

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that the University of Athens has published results of new work undertaken in head and neck squamous cell carcinoma (HNSCC) demonstrating the use of ANGLE's Parsortix® system in the analysis of gene expression and epigenetic alterations (DNA methylation markers) on circulating tumor cells (CTCs) from a simple blood test.

Head and neck cancer is the sixth most common cancer in the world accounting for more than 550,000 occurrences and 300,000 deaths each year, and the 5-year overall survival rate is extremely low at 40% to 50%1. HNSCC is a devastating disease and novel treatments are urgently needed. The researchers believe that "molecular characterization of CTCs can be a powerful prognostic tool while serial assessments of CTCs at different time points during treatment may guide treatment decisions".

To assess the potential for molecular characterisation of CTCs enriched by Parsortix, the researchers undertook a direct comparison of Parsortix using identical blood draws with an antibody-based approach to CTC capture for 50 HNSCC patients and 18 healthy volunteers. The results demonstrated that the Parsortix system had key advantages including:

· much higher CTC harvesting positivity rates;

· higher purity samples with lower levels of non-specific contaminant cells;

· excellent RNA quality for molecular analysis;

· higher relative expression levels for key cancer genes, including PDL1, which is a key target for immunotherapy drugs especially in this type of cancer;

· significantly higher proportion of samples testing positive for epigenetic alterations in CTCs (DNA methylation markers), which is a key area for cancer investigation.

The research has been published as a peer-reviewed publication in the Nature Scientific Reports and may be accessed via https://angleplc.com/library/publications/.

Prof Evi Lianidou, Head of the Molecular Diagnostics Laboratory focused on Liquid Biopsy (ACTC lab) at the Department of Chemistry, University of Athens, commented:

"The publication of this work with ANGLE's Parsortix system highlights the advantages of the Parsortix system in head and neck cancer and demonstrates the potential for cancer gene expression and methylation status to be analysed from a simple blood test. We are planning larger studies using Parsortix to demonstrate patient benefit from CTC based testing."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"This work further demonstrates key advantages of the Parsortix system compared to competing solutions. Head and neck cancer represents a large scale medical opportunity for the repeat deployment of ANGLE's Parsortix liquid biopsy solution, with the potential to both improve the patient outcome and simultaneously reduce spend on unsuccessful drugs."

1. Source: https://ascopubs.org/doi/full/10.1200/JGO.18.00219 

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The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2015.

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 cells of interest to users in a format suitable for multiple types of downstream analyses. The system uses 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 allows DNA, RNA and protein analysis, and the live cells harvested can also 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 submission to FDA for clearance is in process for the United States using results from two separate clinical studies of over 250 metastatic breast cancer patients and associated analytical studies. 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 31 peer-reviewed publications and numerous publicly available posters, available on our website.