Angle Regulatory News (AGL)

ANGLE plc ("the Company")

RESEARCH STUDY INVESTIGATES USE OF PARSORTIX LIQUID BIOPSY FOR METASTATIC BREAST CANCER PATIENTS

Pilot study compared Parsortix liquid biopsy to tissue biopsy of a metastatic site

Potential actionable therapeutic targets were found in the Parsortix liquid biopsy that were missed in the tissue biopsy of a single metastatic site

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that University of Southern California (USC) has published peer-reviewed results of new work undertaken in metastatic breast cancer (MBC) highlighting key advantages of a Parsortix liquid biopsy compared to standard of care tissue biopsy. In addition to the known advantages of a non-invasive, repeatable, low cost procedure, USC showed that potential actionable therapeutic targets were found in the Parsortix liquid biopsy that were missed in the tissue biopsy of a single metastatic site.

The research investigated concordance between cancer cells obtained from the blood test (CTCs harvested by Parsortix) and cancer cells obtained from the metastatic tissue biopsy across 4,600 medically relevant genes and demonstrated that the use of single-site metastatic tumour biopsy, which is standard of care under the NCCN US national cancer guidelines, is unlikely to provide complete insight into tumour mutational status. Tissue biopsy is also limited by the quality, quantity and availability of tumour tissue. The study concluded that medically significant mutations may be found in the CTCs that are not expressed in the metastatic tissue biopsy. 51 actionable genes were identified in the CTCs including the 39 most frequently mutated genes in metastatic breast cancer.

This study demonstrates key capabilities of Parsortix for metastatic breast cancer, which is the area of focus for ANGLE's FDA submission currently in preparation with the aim of submission later this quarter (Q3 CY20).

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

Julie Lang, Associate Professor at the Keck School of Medicine of the University of Southern California, commented:

"This study highlights both practical advantages of the Parsortix liquid biopsy in allowing non-invasive repeat biopsies in metastatic breast cancer and technical advantages in identifying actionable therapeutic targets that may be missed when relying on a single site tissue biopsy."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"The demonstration of advanced gene expression analysis techniques on CTCs harvested by Parsortix highlights an important potential clinical use of the Parsortix system once FDA clearance for metastatic breast cancer has been secured."

For further information ANGLE:

The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2015.

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 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 a complete cell they allow DNA, RNA and protein analysis and the live cells harvested can 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 FDA clearance is in process for the United States with a 400 subject clinical study and associated analytical studies 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 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 34 peer-reviewed publications and numerous publicly available posters, available on our website.