Angle Regulatory News (AGL)

ANGLE plc ("the Company")

Parsortix system is "ideal CTC platform for use in clinical trials and clinical patient management"

Independent research confirms high performance of Parsortix® system in isolating CTCs for downstream analysis

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce the publication of new data demonstrating the performance of ANGLE's Parsortix® system in a head-to-head comparison with the leading antibody-based CTC system.

Researchers at Western University and Lawson Health Research Institute, Ontario, Canada, investigated the ability of the Parsortix system to harvest circulating tumour cells (CTCs) using blood from healthy volunteers spiked with tumour cells from an epithelial breast cancer cell line and a mesenchymal prostate cancer cell line.

The authors report that the Parsortix system could harvest significantly more mesenchymal prostate CTCs than the leading antibody-based CTC system and comparable numbers of epithelial breast CTCs. This is clinically relevant because, during the process of cancer metastases, cancer cells undergo morphological and molecular changes to transition from an epithelial to a mesenchymal phenotype. Although the transition to a mesenchymal phenotype is associated with increased metastatic potential and worse prognosis, many CTC isolation methods, including the leading antibody-based system, only identify cells expressing epithelial markers. These findings provide further evidence that the Parsortix system can isolate and harvest a variety of CTCs, irrespective of their surface antigens, for downstream molecular analysis.

Furthermore, unlike the leading antibody-based CTC system, which is used for enumeration, the Parsortix system allowed for the recovery of CTCs for downstream molecular analysis - specifically RNA expression. Rather than simply identifying the presence of CTCs, Parsortix has the ability to inform meaningful clinical decisions and provides a minimally invasive means to monitor disease and provide targeted treatment over time.

The authors conclude that the Parsortix system has many unique attributes which position it as an "ideal CTC platform for use in clinical trials and clinical patient management". This includes easy cell marker customisation and the ability to harvest CTCs for downstream analysis.

The research, which has been published in the peer-reviewed journal of Clinical & Experimental Metastasis, may be accessed via https://angleplc.com/library/publications/.

Professor Alison Allan - Senior Oncologist, London Regional Cancer Program and Chair of the Department of Anatomy and Cell Biology, Western University, Ontario, Canada commented: 

"It is estimated that 90% of cancer related deaths are due to metastatic disease because current therapies are non-curative against these aggressive cancers. Epithelial to mesenchymal transition (EMT) is well established as an important marker of metastasis, giving rise to cells with greater migratory capacity and invasiveness. However, many technologies used to detect CTCs rely on epithelial biomarkers. Here we demonstrate the unique attributes of Parsortix which position it as an ideal CTC platform for use in the clinic, including metastatic patients with predominantly mesenchymal CTCs."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We welcome the publication of this study by Professor Allan's group which further demonstrates the capabilities of the Parsortix system to harvest CTCs, irrespective of biomarker status. Furthermore, the Parsortix system provides access to viable tumour cells for downstream analysis making it an optimal platform for personalised medicine and for informing the development of targeted therapies.

We look forward to harnessing Parsortix's unique capabilities as we continue to make strong progress with the establishment of approved clinical laboratories to support the use of the Parsortix system for pharma services and subsequent clinical deployment for clinical use. As previously announced, the Parsortix system has been submitted to FDA, seeking the first ever FDA clearance for a system that harvests cancer cells from a simple blood draw for subsequent analysis."

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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 thus 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. In addition, the live CTCs harvested can be cultured, which offers the potential for testing 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 38 peer-reviewed publications and numerous publicly available posters, available on our website.