Angle Regulatory News (AGL)

ANGLE plc ("the Company")

LUNG CANCER STUDY USES ANGLE'S PARSORTIX SYSTEM

Leading ANGLE customer has established a multi-centre study using Parsortix seeking to identify markers for early prediction of cancer relapse in non small cell lung cancer

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that a leading customer has established a multi-centre study to investigate biomarkers on circulating tumor cells (CTCs), using ANGLE's ParsortixTM system, which may give advance warning of relapse in non small cell lung cancer (NSCLC).

The study is being conducted by the Hellenic Oncology Research Group ("Hellenic") lead by the Principal Investigators, Associate Professor Athanasios Kotsakis and Professor Vassilis Georgoulias of the IASO General Hospital in Athens, Greece and is investigating both ctDNA (circulating tumor DNA, fragments of dead cancer cells) and CTCs. The CTC evaluation is being undertaken by the University of Athens lead by Professor Evi Lianidou. Parsortix is the only CTC system being used in the study.

Lung cancer has the highest incidence and mortality rate of all cancers (World Cancer Factsheet 2018: 2.1 million new cancer cases and 1.8 million deaths per annum). Even where the cancer is detected early, 45% of all NSCLC patients will suffer disease recurrence within 8 to 18 months of surgery. Where the cancer is detected late, the situation is far worse. Advance warning of potential cancer relapse in NSCLC has the potential to improve patient outcomes by allowing targeted treatment earlier than would otherwise happen. Solid tissue biopsies are impractical on the repeat basis needed for follow-up monitoring. Where they are possible, the tissue biopsy is expensive, and carries significant risk: up to 24% cause serious complications and up to 1% result in death.

The Hellenic study involves 50 operable early stage NSCLC patients having liquid biopsy blood tests prior to surgery, one month after surgery and then every three to six months until relapse. The study is scheduled to complete in December 2021. CTCs harvested from patient blood using the Parsortix system will be analysed using qRT-PCR and FISH to identify tumor clonal evolution with the intention of identifying both predictors of relapse and indications of suitable treatment.

Prof Evi Lianidou, Head of the Molecular Diagnostics Laboratory focused on Liquid Biopsy, University of Athens, commented:

"Following our successful work in head and neck cancer with ANGLE's Parsortix system, we are delighted to have initiated this important longitudinal study in non small cell lung cancer (NSCLC). There is a major unmet medical need in NSCLC to predict early relapse and identify targeted therapies for personalised care. We are excited about the potential for analysis of CTCs harvested by the Parsortix system to make a real difference for these patients."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"This is another example of ANGLE's product based leveraged R&D approach delivering key benefits with a major study, which is being developed, executed and funded by a leading customer. The high incidence and mortality rates of lung cancer create a pressing need for repeat biopsies to allow personalised medicine and we hope that our Parsortix liquid biopsy system can play a key role in delivering this to the benefit of patients, opening new markets for ANGLE."

For further information ANGLE:

For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/

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 an epitope-independent 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 ParsortixTM 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 downstream subsequent analyses. CTCs enable the complete picture of a cancer to be seen as they allow DNA, RNA and protein analysis and the live cells harvested can be cultured. The Parsortix technology is the subject of 21 granted patents in Europe, the United States, Canada, India, China, Japan and Australia with three extensive families of patents are being progressed worldwide. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The Parsortix system has a CE Mark in Europe for the indicated use and FDA clearance is in process for the United States with a 400 subject study in metastatic breast cancer. ANGLE is seeking to be the first ever FDA cleared CTC harvesting system and only the third ever FDA cleared liquid biopsy test. ANGLE has already undertaken 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 (ROC-AUC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimisation, and is currently in the process of a 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 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 (ROC-AUC) 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 QIAGEN, Abbott and Philips, 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 18 peer-reviewed publications and numerous publicly available posters, available on our website.