Angle Regulatory News (AGL)

ANGLE plc ("the Company")

LEADING CUSTOMER DEMONSTRATES USE OF PARSORTIX FOR SINGLE CELL ANALYSIS OF CIRCULATING TUMOR CELLS

 Measurement of gene expression shows heterogeneity between cancer cells and may help guide treatment in the future

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that one of its leading customers, the Disseminated Cancer Cell Network (DCCNet), Duesseldorf, an interdisciplinary team of cancer researchers and clinicians, has published new results in a peer-reviewed journal of work done to develop a "robust, reliable and cost-efficient workflow" for enrichment of single circulating tumor cells (CTCs).

This has been published by the DCCNet at the University Hospital and Medical Faculty of the Heinrich-Heine University of Duesseldorf as a peer-reviewed publication in the journal Cancers and is available at https://angleplc.com/library/publications/.

The researchers combined use of the Parsortix® system with the micromanipulator CellCelector™ to enable single CTCs to be analysed individually to investigate the heterogeneity of the cancer. They were able to complete PCR-based gene expression analysis of single CTCs processed by Parsortix direct from the patient sample as well as from cells obtained from Parsortix and subsequently cultured outside the patient. This approach may facilitate complex therapeutic decision-making based on the CTC analysis.

The work was undertaken in breast cancer and was able to detect varying gene expression between the individual CTCs as well as demonstrating that changes in the patient's HER-2 expression can be detected.

Dr Hans Neubauer, University Hospital and Medical Faculty of the Heinrich-Heine University of Duesseldorf commented:

"The ability to analyse single CTCs provides a wider understanding of the patient's cancer and may shed greater insight into drug resistance enabling improved therapeutic selection and response. The Parsortix system addresses key issues by removing large numbers of white blood cells whilst retaining the viability of the CTCs for subsequent culture."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"This new workflow provides a simple and effective approach to single cell CTC analysis, which is a developing area of research use for the Parsortix system. Investigation of gene expression and HER-2 status in breast cancer will be an important application of Parsortix following FDA clearance."

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