Angle Regulatory News (AGL)

ANGLE plc ("the Company")

PARSORTIX SYSTEM ENABLES GENE EXPRESSION ANALYSIS IN METASTATIC PROSTATE CANCER PATIENTS

Parsortix able to isolate CTCs in 80% of patients providing access to tumour material for gene expression analysis when tissue biopsy not feasible

Longitudinal patient monitoring using Parsortix showed reduction in CTCs with patient drug response providing further evidence to support the use of Parsortix in pharma services business

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that the Medical University of Innsbruck, Austria has published results from a study in metastatic prostate cancer (mPCa) patients. A key aim of this study was to demonstrate the ability to analyse gene expression in circulating tumour cells (CTCs), which may help guide treatment decision-making for a diverse range of mPCa patients with differing tumour burdens and various prior therapies.

Despite the study not investigating mesenchymal CTCs (those that have been through EMT, the epithelial-mesenchymal transition known to occur during disease progression), and the capture of which is a particular strength of the Parsortix system, epithelial CTCs were recovered using the Parsortix system which could then be analysed for gene expression in 80% of patients.

Longitudinal monitoring of one patient was undertaken using the Parsortix system, with five blood draws over a six-month period, and it was notable that the presence of CTCs declined from around 30 CTCs in a 7.5ml blood sample to zero when that patient responded positively to therapy. This finding further supports the potential for use of the Parsortix system to monitor drug response in cancer drug trials which are assessing patients before, during and after therapy and the researchers believe that further studies to monitor drug response in a larger cohort of patients are warranted. Longitudinal analysis cannot be routinely undertaken using tissue biopsy during clinical trials as repeat samples are generally not available and is the basis of ANGLE's pharma services business established earlier this year.

It is estimated that 1 in 8 men will be diagnosed with prostate cancer in their lifetime. There are an estimated 3.2 million men living with prostate cancer in the United States alone, with 250,000 new cases anticipated in 2021.

Since tumour tissue material is generally unavailable in metastatic prostate cancer, CTCs provide non-invasive and repeatable access to tumour cells and, in accordance with the National Comprehensive Cancer Network (NCCN) guidelines, allow for biomarker testing at all stages of prostate cancer to inform targeted treatment. This study and others, highlight the utility of CTCs in analysing molecular changes in tumour cells in prostate cancer to inform personalised therapy decisions.

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

Prof Iris E. Eder from the Department of Urology, Medical University Innsbruck, Austria, commented:

"Since tissue material is often lacking in metastatic prostate cancer (mPCa), there is increasing interest in using liquid biopsies to inform treatment decisions and monitor therapy response. Our study is focused on the expression of a limited gene panel in an unselected, very heterogeneous cohort of patient samples, who are representative of prostate cancer patients found routinely in a clinical setting. Further studies are now under way to clearly define the molecular expression pattern of CTCs through RNA sequencing in order to obtain a gene panel in a defined cohort of patients with mPCa, which may be of clinical prognostic value."

ANGLE Founder and Chief Executive, Andrew Newland, said:

"The study demonstrated gene expression analysis of the cancer cells, in this case using an established molecular analysis technique, qPCR, which is used widely with tissue biopsy. This study therefore provides further evidence of the capability of the Parsortix system to provide cancer cells for analysis from a simple blood test when tissue biopsy is not feasible, with the potential to guide future treatment decisions.

The study adds to the body of evidence for the Parsortix system in relation to prostate cancer, which is the focus for ANGLE's first large scale pharma services contract and continues to be a key area for ANGLE's development efforts following our recent capital raise."

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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 tumour 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 tumour. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumour 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 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 (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 48 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.