Angle Regulatory News (AGL)

ANGLE plc ("the Company")

MET EXPRESSION OF PARSORTIX-HARVESTED CTCs FROM CANCER PATIENTS HAS POTENTIAL AS BIOMARKER FOR MET INHIBITOR DRUG TRIALS

Potential for liquid biopsy solution to drive new areas of cancer treatment

Parsortix performance demonstrates key advantages over alternative approaches

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that the Liquid Biopsy Analysis Unit at the Health Research Institute of Santiago, Spain has published results of new work undertaken in head and neck cancer and non small cell lung cancer on the potential utility of a liquid biopsy-based strategy to assess MET alterations on circulating tumour cells (CTCs).

MET alterations in cancer patients may provide a biomarker to evaluate which patients will benefit from treatment with a new class of drug called MET inhibitors. The MET-related cancer pathways can activate cell proliferation, survival, migration, motility, invasion, angiogenesis, apoptosis and epithelial-to-mesenchymal transition. Thus, the MET pathways have a fundamental bearing on the rate of growth and spread of cancer.

MET changes have mostly been associated with metastatic patients and normally appear with progression of the cancer. Consequently the original tissue biopsy may be out-of-date and unreliable for assessing the current MET status. Repeat tissue biopsies may not be possible if the metastatic site cannot be accessed, the patient is too ill for the invasive procedure or there is insufficient tissue available for biopsy analysis. The researchers are the first to investigate the use of liquid biopsy systems to capture CTCs in order to investigate MET expression levels in the cancer, in a study comparing the utility of Parsortix to that of the leading antibody-based CTC system.

The head and neck cancer results using Parsortix showed a significant association of the presence of MET positive CTCs, which was a minority of patients, and poorer overall survival of those patients. For comparative purposes, the leading antibody-based CTC system was utilised in parallel with the same patients. This system had significantly lower CTC positivity than Parsortix and there was no relationship between MET expression in the CTCs obtained by the antibody-based system with patient survival.

This research suggests that there is potential for the Parsortix system to be used as part of a biomarker approach in cancer drug trials of MET inhibitors, and then potentially as a companion diagnostic to identify patients likely to respond to the MET inhibitor drugs. The paper entitled "Detection of MET Alterations Using Cell Free DNA and Circulating Tumor Cells from Cancer Patients" has been published in the peer-reviewed journal Cells and can be accessed via https://angleplc.com/library/publications/.

Dr Roberto Díaz Peña, Liquid Biopsy Analysis Unit, Health Research Institute of Santiago, Spain, commented:

"This work generates the first proof-of-concept for a biomarker approach to assist in stratifying patients that may respond to new MET inhibitor cancer drug trials. The Parsortix-based approach to MET analysis we have developed, may assist in the development of a new direction of therapy for cancer."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"The analysis of MET status on CTCs using Parsortix is a new and promising area of investigation for cancer treatment. This research further demonstrates Parsortix's applicability and we will now consider how we can add it to our sample-to-answer imaging solutions for use in pharma services cancer drug trials."

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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 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 cells of interest to users in a format suitable for multiple types of downstream analyses. The system uses 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 a complete cell allows DNA, RNA and protein analysis, and the live cells harvested can also 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 Parsortix system has a CE Mark in Europe for the indicated use and submission to FDA for clearance is in process for the United States using results from two separate clinical studies of over 250 metastatic breast cancer patients and associated analytical studies. 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 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 (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 33 peer-reviewed publications and numerous publicly available posters, available on our website.