ANGLE plc ("the Company")

PARSORTIX SYSTEM UTILITY DEMONSTRATED IN OESOPHAGEAL CANCER FOR THE FIRST TIME

Parsortix system consistently harvests CTCs of high quality

Research paves the way for downstream molecular analysis to enable targeted treatment in this hard-to-treat cancer

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that the University Hospital Ghent, Belgium has published results of research undertaken in oesophageal cancer, using ANGLE's Parsortix^® system. These are the first published results in this cancer type, with the Parsortix system now validated in 24 cancer types in 28 independent cancer research centres located across 11 countries.

Researchers utilised ANGLE's marker-independent Parsortix system to isolate epithelial circulating tumour cells (CTCs) in patients and then performed cell-based image analysis to compare cell morphology and characteristics. The study validated how this workstream could be utilised for downstream molecular analysis of cancer biomarkers from single CTCs in a future study. This would enable individualised targeted therapy from a simple blood draw, with National Comprehensive Cancer Network (NCCN) guidelines recommending biomarker testing for HER2, PD-L1 and microsatellite instability to inform treatment selection.

The International Agency for Research on Cancer reports that there were 600,000 cases of oesophageal cancer and 545,000 deaths in 2020. Despite an improvement in survival rates, oesophageal cancer is a deadly disease with 80% patient mortality at 5 years from diagnosis. This is in part due to late diagnosis, with 40% of patients diagnosed with metastatic disease and a further 35% diagnosed with Stage III disease. There is an urgent need for targeted treatment options to improve patient outcomes.

This study analysed only one subset of CTCs: those with epithelial characteristics. The authors are planning further research, which will also investigate mesenchymal CTCs and those undergoing epithelial to mesenchymal transition (EMT). These subsets of CTCs are most clinically relevant given their abundance in late-stage disease and ability to initiate metastatic spread and are therefore key targets for drug development. The Parsortix system is ideally placed to isolate these clinically relevant cells as a size and deformability-based system which is marker independent.      

The research has been published as a peer-reviewed publication PLoS One and may be accessed via https://angleplc.com/library/publications/.  

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"Treatment selection for oesophageal cancer remains a major unmet medical need and we are pleased that this study demonstrates the promise of the Parsortix system in improving the outcomes for these patients. We believe that additional studies focused on clinically relevant mesenchymal CTCs, which can be captured and analysed using the Parsortix system, are urgently needed and we look forward to the Ghent team progressing their work in this hard-to-treat cancer type."   

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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 the cells of interest to the user in a format suitable for multiple types of downstream analyses. The system is based on 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 an intact cell they allow DNA, RNA and protein analysis and may provide comparable analysis to a tissue biopsy. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status of a patient's tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor response to drugs outside the patient. 

The Parsortix technology is the subject of 26 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, in the United States, a De Novo Submission has been made to FDA for the Parsortix® PC1 system seeking FDA clearance with Class II Classification for use with metastatic breast cancer patients. FDA clearance is seen as the global standard. ANGLE is seeking to be the first ever FDA cleared system for harvesting CTCs for subsequent analysis. 

ANGLE has also completed 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 (AUC-ROC) 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 (AUC-ROC) 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 43 peer-reviewed publications and numerous publicly available posters, available on our website.

ANGLE has established clinical services laboratories in the UK and USA to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services to pharmaceutical and biotech customers for use of the Parsortix system in cancer drug trials and, once the laboratories are accredited, and tests validated, will provide Laboratory Developed Tests (LDTs) for patient management.