Angle Regulatory News (AGL)

ANGLE plc ("the Company")

ANGLE'S PARSORTIX SYSTEM SHOWCASED IN SIX POSTER PRESENTATIONS AT LEADING CANCER CONFERENCE AACR 2019

Customers publish data from four independent studies demonstrating success with ANGLE's Parsortix liquid biopsy system

ANGLE publishes detailed analytical performance data of Parsortix and HyCEAD Ziplex downstream analysis systems

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, today announces that its ParsortixTM system has been showcased by a number of customers in poster presentations at the American Association for Cancer Research conference (AACR) 2019, in Atlanta, Georgia, United States from 29 March to 3 April 2019.

In addition, ANGLE presented detailed performance data from the optimisation of its ovarian cancer assay for both its Parsortix and HyCEAD Ziplex systems at the conference.

Work by the University of Athens lead by Professor Evi Lianidou was particularly important as it demonstrated the superior performance of the Parsortix system in head and neck squamous cell carcinoma (HNSCC) in matched samples when compared with an antibody-based CTC enrichment approach. Superior sensitivity of Parsortix was demonstrated for the expression of multiple genes.

Expression of PD-L1 is of particular importance as it is the target for leading immunotherapy drugs including Nivolumab (Opdivo®) manufactured by Bristol Myers Squibb and Pembrolizumab (Keytruda®) manufactured by Merck. These drugs can be very effective for some patients. Only a minority of patients will respond and it is crucial to be able to accurately identify which ones. In the matched comparison of PD-L1 expression in 50 HNSCC patients, the Parsortix system identified 9/50 with PD-L1 expression whereas the antibody-based approach only identified 4/50. Around 1 in 5 patients may be expected to respond to PD-L1 immunotherapies so the Parsortix result is consistent with expected detection levels.

As well as this work by the University of Athens, ANGLE's Parsortix system has been showcased in the following poster presentations at AACR 2019:

Poster Presentations

1) University of Athens, Greece: Molecular characterisation of circulating tumor cells in head and neck squamous cell carcinoma: Direct comparison of a label-independent size-based microfluidic device with EpCAM-based CTC enrichment.

2) Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Italy: Molecular characterization of circulating tumor cells in cholangiocarcinoma patients: A new tool for treatment management?

3) Northwestern University, Chicago, United States: Increased chromatin heterogeneity in circulating tumor cells (CTCs) is associated with high levels of HER2 expression in metastatic breast cancer (MBC)

4) University of Athens, Greece: Detection of CK-19 mRNA positive CTCs, isolated with a size-based microfluidics platform, in NSCLC patients under osimertinib therapy.

5) ANGLE: ParsortixTM system: Analytic performance evaluation using ovarian cancer cell lines

6) ANGLE: Multiplex gene expression using the HyCEAD assay in CTCs isolated with the ParsortixTM system

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"The multiple poster presentations by ANGLE and its customers at AACR demonstrate new potential applications for ANGLE's Parsortix system and further builds the third-party evidence that Parsortix is a market-leading CTC liquid biopsy solution. The successful detection of PD-L1 in head and neck cancer opens the potential for collaboration with leading pharma companies with FDA cleared immunotherapy drugs."

Where released by customers, the published posters are available on ANGLE's website at https://angleplc.com/library/publications/. 

For further information ANGLE:

This announcement contains inside information.

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 ParsortixTM 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 21 granted patents in Europe, the United States, Canada, India, China, Japan and Australia 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 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 QIAGEN, Abbott and Philips, 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 18 peer-reviewed publications and numerous publicly available posters, available on our website.