ANGLE plc ("the Company")

ANGLE'S PARSORTIX SYSTEM SHOWCASED IN POSTER PRESENTATION AT NATIONAL CANCER RESEARCH INSTITUTE (NCRI) FESTIVAL

Study in metastatic prostate cancer presented at NCRI Festival demonstrates longitudinal analysis of CTCs harvested using the Parsortix system is predictive of treatment response

KLK2 gene expression on CTCs found to be a more effective biomarker for assessing likelihood of cancer progression than current standard of care

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that a poster presentation showcasing the Parsortix^® system was presented yesterday at the National Cancer Research Institute (NCRI) Festival, being held 8-12 November 2021. The poster showcases findings from a Barts Cancer Institute study in metastatic prostate cancer which undertook circulating tumour cell (CTC) analysis to evaluate docetaxel drug treatment response and resistance markers.

Longitudinal CTC sampling was performed using the Parsortix system in 56 patients. The samples were taken before patients started docetaxel treatment, during treatment, and after completing all doses over a period of 6-8 months. A total of 205 CTC samples were analysed for changes in CTC number, phenotype, and mRNA gene expression.

Multiplex qPCR analysis, using a custom designed 32 gene panel of CTC mRNA revealed that patients with disease progression who have worse predicted survival rates had high expression of the KLK2 gene at each blood collection time point and that this was significantly more predictive than the current standard of care for assessing the likelihood of progression, which is based on blood PSA levels. These findings are significant as they highlight KLK2 as a possible alternative and a better biomarker for prostate cancer prognosis.

This study concludes that longitudinal analysis of CTCs isolated using the Parsortix system can predict whether a patient is resistant or developing resistance to treatment with docetaxel. As such, it could be used as an early biomarker for treatment response. Study findings could enable doctors to detect early on, and without invasive procedures, if a treatment is working and switch to alternatives if it is not.

Prostate cancer is the leading cause of cancer in men and accounts for 13% of all new cancer cases in the United States. In 2021, the National Cancer Institute estimates that there will be 248,500 new cases in the United States with an additional 3.2 million men living with the disease. The current standard of care, transrectal ultrasound-guided prostate tissue biopsy, is an invasive procedure associated with clinical complications where 32% of patients will experience moderate side effects and 1.4% of patients experience major complications. This includes post-biopsy sepsis in 2-5% of cases with up to 25% requiring admission to ICU. Liquid biopsy offers the potential for safe, cost-effective longitudinal monitoring of tumour evolution and disease progression to track mutations responsible for therapy resistance and identify biomarkers for targeted treatment selection.

Caitlin Davies, study author and PhD research student at Barts Cancer Institute, Queen Mary University of London, UK, commented:

"This insight into how CTC dynamics lead to reduced progression-free and survival times is vital for clinicians. It will enable them to make early changes of treatment from docetaxel to an alternative, which may significantly improve patients' chances of long-term survival. Furthermore, analysis of CTC gene expression and detection of genes associated with resistance to docetaxel may aid the development of a new generation of therapies.

Professor Hashim Ahmed, Chair of the NCRI Prostate Group and Professor of Urology at Imperial College London, UK, who was not involved in the research, said:

"These are promising results and have the potential to change clinical practice, if they are confirmed by further research.  Assessing the responsiveness of an individual patient's tumour to docetaxel treatment by means of blood tests will enable clinicians to personalise cancer treatment more easily and effectively, without the patient having to undergo invasive procedures such as tissue biopsies. It could also help to avoid patients undergoing unpleasant systemic treatments that are going to be unsuccessful."

ANGLE Founder and Chief Executive, Andrew Newland, added:

"We are pleased that Barts has presented this promising data showcasing longitudinal analysis using the Parsortix system. Their findings not only demonstrated the Parsortix system's potential to guide treatment decisions but also its ability to help identify new biomarkers for assessing likelihood of progression in prostate cancer and as possible targets for new drug therapy. This evidence provides further support for our pharma services business which offers longitudinal analysis for drug trials in multiple cancers and for our planned studies to develop a prostate cancer assay to offer as a laboratory developed test from our own laboratories." 

The poster and abstract are available 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 49 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.