Harvesting CTCs from brain metastasis patients

ANGLE plc ("the Company")

PARSORTIX USED TO SUCCESSFULLY HARVEST CANCER CELLS FOR ANALYSIS FROM THE BLOOD OF PATIENTS WITH BRAIN METASTASIS

Parsortix successful in overcoming challenges associated with isolating CTCs from brain metastasis patients in three different cancer types

Analysis of CTCs may enable more personalised care for cancer patients with brain metastasis where traditional tissue biopsy is not possible

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that University Medical Centre Hamburg-Eppendorf has published results of new work undertaken in patients with brain metastasis demonstrating use of ANGLE's Parsortix^® system in the isolation of circulating tumour cells (CTCs). In addition, the research investigated the role of two proteins, CD74 and CD44, in the development of brain metastasis.

Liquid biopsy from peripheral blood is a particularly attractive solution in brain cancer because of the difficulty, medical complications and cost associated with taking a tissue biopsy from the brain. The characterisation of metastatic tumour cells can be crucial in helping to inform personalised treatment decisions, but, because of the serious risks involved, most patients with brain metastasis will never undergo a tissue biopsy unless undergoing surgical tumour resection.

Historically, detection of CTCs from peripheral blood in brain metastasis has been hampered by the blood-brain-barrier which results in fewer CTCs in peripheral blood compared to other metastatic sites and, because these CTCs have a more mesenchymal state, they are poorly detected using antibody-based systems. In this study, 44 patients with primary breast cancer, non-small cell lung cancer (NSCLC) and melanoma with subsequent brain metastases were screened for CTCs using the Parsortix system. CTCs were detected in 50% of breast cancer patients, 50% of NSCLC patients and 36% of melanoma patients. CTC positivity rates were superior when compared to previous studies into cancer brain metastases which utilised other CTC enrichment technologies, including the leading antibody-based system where positivity rates of 20-22% in breast cancer and 12.5% in NSCLC have been reported.

Brain metastases are the most common type of brain tumour accounting for 88% of all new cases. The incidence of cancer brain metastases is increasing as new therapeutics, advanced imaging, and improved screening have led to increased survival following a primary diagnosis of cancer with approximately 200,000 new cases of brain metastases being diagnosed in the United States each year.

Brain metastases are a significant cause of morbidity and mortality in patients. Prognosis is poor with life expectancy usually less than a year and a five-year survival rate of only 2.4%. In addition, brain metastases are associated with loss of cognitive and sensory function and, in many patients, lead to a significant reduction in quality of life.

This study further confirms the utility of the Parsortix system for the isolation and characterisation of CTCs in brain metastases and that a Parsortix-based blood test may provide additional medical information to inform treatment decisions that could otherwise only be obtained by a highly invasive tissue biopsy of the patient's brain.

The research has been published as a peer-reviewed publication in the International Journal of Molecular Sciences and may be accessed via https://angleplc.com/library/publications/.   

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"This is important new work by the world-leading Hamburg-Eppendorf cancer centre. Prof. Wikman and her team have demonstrated the utility of the Parsortix^® system in isolating CTCs from cancer brain metastases and demonstrated superior CTC positivity rates than those seen in studies using other enrichment technologies. Cancer brain metastases cannot be accessed for tissue biopsy without highly invasive procedures and a liquid biopsy alternative would be of great benefit to patients to monitor and optimise treatment." 

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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 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 46 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.