Angle PLC - Study Highlights Superior Performance of Parsortix

PUBLICATION HIGHLIGHTS EASE OF USE AND SUPERIOR PERFORMANCE OF PARSORTIX SYSTEM IN HARVESTING CTCs FROM METASTATIC BREAST CANCER PATIENTS

• Quantity, purity and quality of CTCs captured using the Parsortix system shown to be superior to an alternative antibody-based approach
• Study supports integration of the Parsortix system into histology laboratories for routine clinical use

GUILDFORD, UK / ACCESSWIRE / August 9, 2021 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that the Institute of Oncology, Ljubljana, Slovenia has published favourable results from a preliminary study in metastatic breast cancer (MBC) patients. The study compared ANGLE’s Parsortix^® system to an alternative antibody-based approach for the isolation of circulating tumour cells (CTCs) to determine whether these systems could be integrated into routine laboratory use.

For the purpose of this research, thirty MBC patients donated two 10mL blood samples, which were processed in parallel by both systems. CTCs were identified by their morphology (as opposed to biomarkers) using light microscopy which is universally available in pathology departments. This method of CTC identification is the standard laboratory practice for cytopathological and histological examination of tumour cells from tissue biopsy.

Results from this study showed that the Parsortix system was able to harvest CTCs in a greater proportion of MBC patients (64%), compared to the antibody-based system (57%), and 99% of the cancer cells recovered by the Parsortix system had preserved morphology, allowing morphological analysis, whereas less than 1% of the cells recovered by the antibody-based system had preserved morphology. In addition, samples processed using the Parsortix system were also found to be of higher purity, with fewer blood cells present in the harvest.

The proportion of MBC patients where cancer cells could be harvested for analysis using the Parsortix system also significantly exceeded the proportion of patients where cancer cells can be recovered from metastatic sites using tissue biopsy as less than 50% of MBC patients receive a successful tissue biopsy in accordance with US National Comprehensive Cancer Network (NCCN) clinical practice guidelines due to being too sick for the invasive procedure, inaccessibility of the tumour or failed procedures.

The authors concluded that these results, combined with its ease of use, position the Parsortix system as the optimal system for integration into a routine cytopathology laboratory.

Breast cancer is the leading cause of cancer in women worldwide. The National Cancer Institute estimates that 282,000 women will be diagnosed with breast cancer in the US in 2021. A further 3.7 million US women are living with breast cancer. Despite a 5-year relative survival rate of 90%, up to 30% of women will develop metastatic disease. MBC patients where a tissue biopsy is not feasible under NCCN guidelines, or is unsuccessful, are an immediate focus for a liquid biopsy alternative to provide information to guide treatment.

The research has been published as a peer-reviewed publication in the journal Radiology and Oncology and may be accessed via https://angleplc.com/library/publications/.

Prof Veronika Kloboves-Prevodnik, Head of the Department of Cytopathology, Institute of Oncology, Ljubljana, Slovenia commented:

‘This study, aimed to identify which of the two separation methods is more appropriate for integration into our routine clinical cytopathology laboratory. In our metastatic breast cancer cohort, we found that the Parsortix system, was in general superior to the antibody-based system in terms of purity, quality, and quantity of CTCs. The advantage of the size-based Parsortix system is its ability to harvest cells with a range of phenotypes. The approach is promising and might be integrated into routine cytopathology laboratory practice in the near future. To achieve that, more data about immunocytochemical determination of CTC phenotypes and correlation with clinical data are needed.’

ANGLE Founder and Chief Executive, Andrew Newland, added:

‘We are pleased to see such promising results from a new independent cancer centre which, again, demonstrates the strong capabilities of the Parsortix system in isolating intact cancer cells from a simple blood test at high purity for downstream analysis using widely available methods. This is key to our aim of establishing the Parsortix system as the global standard for liquid biopsy from CTCs.’

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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 47 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.

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SOURCE: ANGLE plc

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