Angle Regulatory News (AGL)

ANGLE plc ("the Company")

NEW STUDY HIGHLIGHTS USE OF PARSORTIX SYSTEM TO ENABLE CANCER CELL DNA ANALYSIS IN NON-SMALL CELL LUNG CANCER

Published study results found DNA methylation of genes from liquid biopsies provide insight into prognosis for early-stage non-small cell lung cancer patients

DNA methylation analysis has potential to be utilised for cancer diagnosis and epigenetic cancer research

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that the world-class research team led by Prof. Evi Lianidou at the National and Kapodistrian University of Athens, Greece, has recently published results of a study undertaken in early-stage non-small cell lung cancer (NSCLC), which demonstrates the benefit of analysing epigenetic alterations in circulating tumour cells (CTCs) to assess patient prognosis.

DNA methylation is a hallmark of cancer. The aim of the study was to evaluate the prognostic value of DNA methylation in five specific tumour suppressor genes commonly associated with tumour growth and metastasis in liquid biopsy samples. The researchers used the Parsortix® system to isolate CTCs from 42 early-stage NSCLC patients for DNA methylation analysis. 

After harvesting from the Parsortix system, captured CTCs were lysed and genomic DNA was extracted. Once DNA integrity had been evaluated, the DNA was amplified and methylation detected by real-time methylation specific PCR assays for the targeted genes. The isolation of DNA from intact cancer cells using the Parsortix system is advantageous as it provides a prospective outlook, allowing real-time monitoring of tumour evolution as opposed to ctDNA which is typically derived from dead or dying cells and thus may fail to capture the most clinically relevant and up to date tumour characteristics.

This research identified that DNA methylation of at least one of the five selected genes in CTC or ctDNA samples was associated with a worse prognosis in early-stage NSCLC. The study highlights the potential of DNA methylation analysis from a CTC based liquid biopsy to provide prognostic information for patients with early-stage NSCLC.

In the United States, lung cancer is the second most common cause of cancer and the leading cause of cancer related mortality, responsible for 22% of all cancer related deaths. In 2022, the National Cancer Institute estimates that there will be a total of 236,740 new cases and 130,180 deaths with NSCLC accounting for 84% of all lung cancer cases. Whilst the overall 5-year survival rate for NSCLC is 23%, 55% of patients are diagnosed with metastatic (stage IV) disease for which the 5-year relative survival rate is just 7%.

Professor Evi Lianidou, Head of the Molecular Diagnostics Laboratory focused on Liquid Biopsy (ACTC lab) at the Department of Chemistry, National and Kapodistrian University of Athens, commented:

"This research indicates that the combination of DNA methylation analysis of tumour suppressor genes in CTCs and matched plasma-ctDNA provides significant prognostic information in patients with early-stage non-small cell lung cancer. Additional studies are required to validate our findings in a larger cohort of patients."

ANGLE Founder and Chief Executive, Andrew Newland, added:

"We are pleased to report on the use of the Parsortix system for the isolation of CTCs in early-stage NSCLC, showing potential to enable genetic analysis that provides informative prognostic information. This showcases the potential of liquid biopsy, using the Parsortix system, as a promising tool for the assessment of early-stage disease, which is a key priority for healthcare systems world-wide."

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

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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 known as the Parsortix® system and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.

ANGLE's Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood.

Intended use

The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays. The end user is responsible for the validation of any downstream assay. The standalone device, as indicated, does not identify, enumerate or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions.

The Parsortix system enables a liquid biopsy (a simple blood test) to be used to provide the circulating metastatic breast cancer cells 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 phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable form (alive). CTCs harvested from the system enable a complete picture of a cancer to be seen; as being an intact cell they allow DNA, RNA and protein analysis as well as cytological and morphological examination and may provide comparable analysis to a tissue biopsy in metastatic breast cancer. 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.

In the United States, the Parsortix® PC1 system has received a Class II Classification from FDA for use with metastatic breast cancer patients. FDA clearance is seen as the global gold standard. ANGLE's Parsortix system is the first ever FDA cleared system for harvesting CTCs for subsequent analysis. ANGLE has applied the IVD CE Mark to the same system for the same intended use in Europe.

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 HyCEADTM 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 64 peer-reviewed publications and numerous publicly available posters from 31 independent cancer centres, available on our website.

ANGLE has established clinical services laboratories in the UK and the United States to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services globally 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.