PARSORTIX SHOWS POTENTIAL FOR IDENTIFYING THERAPEUTIC TARGETS IN PATIENTS WITH TRIPLE NEGATIVE BREAST CANCER

• Parsortix system harvests intact CTCs for whole genome sequencing identifying multiple actionable targets
• Both tumour and CTC samples after pre-surgical chemotherapy show alterations in genes involved in drug resistance

GUILDFORD, UK / ACCESSWIRE / March 25, 2022 / ANGLE plc ("the Company") (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that a leading cancer research institute, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, has published results of a study undertaken in early stage triple negative breast cancer (TNBC) patients undergoing neoadjuvant chemotherapy (NAC; chemotherapy administered before surgery).

Researchers used ANGLE's Parsortix^® system to isolate circulating tumour cells (CTCs) before, during and after NAC treatment, alongside the collection of primary tumour tissue samples pre- and post-treatment, to analyse for copy number alterations (CNAs), through whole genome sequencing and targeted sequencing, respectively.

Using ANGLE's marker-independent Parsortix system to harvest CTCs, followed by automated single-CTC retrieval, the authors identified and analysed both epithelial and non-epithelial CTCs, allowing characterisation of CTCs that would not have been detected by epithelial antibody-based approaches. Analysis of CTCs before, during and after NAC treatment allowed the researchers to track the individual evolution of a patient's TNBC, revealing treatment-induced resistance to the chemotherapy as well as the identification of newly acquired genetic changes that could provide additional treatment options. In two patients, CTCs collected after NAC treatment shared more genomic alterations with the residual tumour, i.e. post-NAC treatment, compared to the primary tumour.

This study demonstrates how CNA analysis of CTCs harvested by the Parsortix system, from early stage TNBC patients pre- and post-NAC treatment, has the potential to provide information on tumour evolution and identify actionable therapeutic targets that could help determine future treatment options for patients with chemotherapy-resistant disease.

In the United States, breast cancer is the most frequently diagnosed cancer in women with 287,000 new cases expected in 2022, accounting for 31% of all new cancer cases. The American Cancer Society estimates that TNBC accounts for about 10-15% of all breast cancers. TNBC differs from other types of invasive breast cancer in that it grows and spreads faster, has limited treatment choices, and a worse prognosis.

Dr Vera Cappaletti, Biomarkers Unit, Department of Experimental Oncology, National Cancer Institute of Milan, commented:

"The extreme heterogeneity of triple negative breast cancer has led to difficulties in finding suitable molecular targets. This has resulted in limited benefit from targeted therapies observed in clinical trials. Implementing longitudinal monitoring, through liquid biopsy of CTCs, is a crucial step for improving treatment efficacy and represents an optimal approach to be pursued in future studies to implement personalized medicine."

ANGLE Founder and Chief Executive, Andrew Newland, added:

"We are pleased to report on the use of the Parsortix system for the unbiased isolation of both epithelial and mesenchymal CTCs in TNBC, uncovering potential new therapeutic targets. ANGLE's ability to provide actionable insights could help patients with limited treatment options and should prove highly attractive to drug developers looking for new approaches for hard-to-treat cancers, such as TNBC."

The research has been published as a peer-reviewed publication in the Journal Scientific Reports and is available online at https://angleplc.com/library/publications/.

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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 a 200 patient clinical verification study has now completed enrolment.

ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEAD^TM 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 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 56 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 Parsortix 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