Angle Regulatory News (AGL)

ANGLE plc ("the Company")

LEADING CANCER CENTRE PUBLISHES PARSORTIX WORKFLOW ADDRESSING PROBLEMS WITH ALTERNATIVE APPROACHES

Workflow for RNA gene expression demonstrated in prostate cancer

Researchers show that "previously undetectable prostate specific transcripts become readily measurable"

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that the University of Southern California has published results of new work undertaken in advanced prostate cancer demonstrating a workflow developed using ANGLE's Parsortix® system to provide rapid circulating tumor cell (CTC) enrichment and transcriptomic profiling in prostate cancer that is scalable in a cost effective way to large numbers of patient blood samples.

Transcriptomic profiling is the process by which cancer cells, in this case harvested by Parsortix from a simple blood test, are analysed to determine their RNA gene expression to identify how the patient's cancer is developing and evading the immune system so that decisions can be made as to which drug treatments may be most effective for that patient at that time. Standard tissue biopsy is invasive and reflects only a single metastatic site at a single point in time, whereas CTC analyses may reflect multiple metastatic sites and are repeatable allowing the dynamic nature of the cancer to be profiled. This approach enables personalised medicine and addresses the major problem of identifying the right drug at the right time as most drugs only work for a proportion of patients and a "one size fits all" approach is limited in its effectiveness.

The researchers identified key advantages of their Parsortix-based workflow compared to other CTC approaches, as follows:

· high enrichment levels (high purity of cancer cells with low levels of contaminating white blood cells) for detection of cancer-specific genes over background noise allowing previously undetectable prostate specific transcripts to become readily measurable;

· minimal manipulation (cancer cells unchanged, alive and not damaged by the process);

· recovered target cells free of antibodies or magnetic beads (a common problem with antibody-based capture methods avoided by the Parsortix cell separation technique);

· epitope agnostic (harvests clinically-relevant mesenchymal CTCs as well as epithelial cells);

· rapid, straight forward and robust workflow;

· flexible downstream applications.

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

Associate Professor Amir Goldkorn, M.D., Associate Director for Translational Research

USC Norris Comprehensive Cancer Center & Keck School of Medicine of the University of Southern California, commented:

"The publication of this work with ANGLE's Parsortix system demonstrates a straightforward and scalable approach, which can be used to investigate novel candidate biomarkers and therapeutic targets in advanced disease."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"University of Southern California's workflow using the Parsortix system is a significant step forward as it demonstrates a simple, effective way to utilise the harvested CTCs for gene expression analysis to advise drug selection decisions and to provide a dynamic analysis of the effectiveness of treatment. We believe the applicability of the workflow will not be limited to prostate cancer and may extend to most, if not all, solid tumor cancer types."

For further information:

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 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 cells of interest to users in a format suitable for multiple types of downstream analyses. The system uses 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 a complete cell allows DNA, RNA and protein analysis, and the live cells harvested can also be cultured. The Parsortix technology is the subject of 24 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 submission to FDA for clearance is in process for the United States using results from two separate clinical studies of over 250 metastatic breast cancer patients and associated analytical studies. 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 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 (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 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 32 peer-reviewed publications and numerous publicly available posters, available on our website.