Parsortix demonstrates high capture rate of CTCs

ANGLE plc ("the Company")

MAJOR EUROPEAN CONSORTIUM PUBLISHES RESULTS OF LARGE-SCALE INVESTIGATION DEMONSTRATING KEY ADVANTAGES OF parsoRtix system in lung cancer

Parsortix system demonstrates high capture rate of CTCs irrespective of biomarker status or phenotype

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce the publication of a five year programme of work undertaken by the CANCER-ID Consortium to establish the performance and technical capabilities of five circulating tumour cell (CTC) isolation platforms, in which key advantages of the Parsortix^® system were identified. The CANCER-ID consortium is supported by Europe's Innovative Medicines Initiative (IMI) and is a Europe-wide Public-Private-Partnership aimed at the establishment of standard protocols for, and clinical validation of, blood-based biomarkers in order to drive wide adoption of liquid biopsy in clinical practice and pharma services.

CTCs are cancer cells present in the blood stream, which can be harvested from a simple blood test, providing minimally invasive access to solid tumours. In their latest research, the Consortium highlights that, when compared to other circulating biomarkers, the clear advantage of harvested CTCs is that they provide insight into RNA expression and proteins, which might provide additional detail to help inform more rational treatment decisions than ctDNA alone. As such, CTCs have the potential to develop superior assays for detection, analysis, and treatment of systemic cancer.

The group selected non-small cell lung cancer (NSCLC) cell lines for its initial focus because of the large number of available targeted therapies. This creates a need for predictive biomarkers to stratify patients and monitor treatment response. CTCs could be a valuable source of such relevant biomarkers. Two cell lines were used with a strong difference in both epithelial marker (EpCAM) expression (to test marker-dependent and marker independent platforms) and size (to test size-dependent isolation methods).

The research has shown that Parsortix performance was robust, with mean cell capture rates of 71% (EpCAM high cell line) and 67% (EpCAM low cell line). In comparison, the leading FDA approved antibody-based CTC system was unable to enrich EpCAM low cells. Parsortix was comparable to the leading antibody-based system with respect to time required for sample processing, staining and cell identification and was considerably faster than some other systems. The use of Transfix^® blood collection tubes, utilised with Parsortix in this study, provided for 5 days' blood stability enhancing the practicability of sample management.

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

Nikolas Stoecklein, Professor for Experimental Surgical Oncology at Heinrich-Heine University, Düsseldorf, Germany commented:

"This multi-national proficiency testing of CTC-enrichment technologies has importance in the establishment of guidelines for clinically applicable preanalytical workflows and the definition of minimal performance qualification requirements prior to clinical validation of technologies. It will remain in operation beyond the funding period of CANCER-ID, in the context of the European Liquid Biopsy Society (ELBS)."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"CANCER-ID is a large scale industrial and government consortium in Europe seeking to accelerate adoption of liquid biopsy solutions in cancer care by standardising protocols. We are pleased that published results of their work over the last five years highlight the advantages of analysing CTCs compared to other liquid biopsy approaches and identify specific advantages of ANGLE's Parsortix system CTC solution.

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 product clearance for a system that harvests cancer cells from a simple blood draw for subsequent analysis."

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Notes for editors

About CANCER-ID CANCER-ID - Innovation in Medicine (cancer-id.eu)

CANCER-ID was a European consortium funded by the Innovative Medicines Initiative (IMI) aimed at the establishment of standard protocols for and clinical validation of blood-based biomarkers. It brought together experts from academic and clinical research, innovative Small-to-Medium sized Enterprises (SMEs), diagnostics companies and the pharmaceutical industry thus providing a unique setting for establishing clinical utility of "liquid biopsies".

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 HyCEAD^TM 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 39 peer-reviewed publications and numerous publicly available posters, available on our website.