Angle Regulatory News (AGL)

ANGLE plc ("the Company")

PARSORTIX OUTPERFORMS OTHER CTC SYSTEMS IN RENAL CELL CARCINOMA

Publication in International Journal of Molecular Sciences demonstrates benefits of Parsortix "unbiased" CTC enrichment process

Workflow combines Parsortix with downstream process for single cell analysis of each individual cancer cell

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that Istituto Nazionale Tumori di Milano, Milano, Italy has published results of work, which assessed the performance of Parsortix® in renal cell carcinoma (RCC) demonstrating key advantages of the Parsortix system.

The disease is often asymptomatic (few or no symptoms) and about 30% of patients with RCC present with metastatic disease. Their prognosis is poor with an overall 5-year survival rate of less than 20%. A number of targeted therapies have recently become available and a liquid biopsy to determine whether such treatments might benefit individual patients would be highly valuable.

Legacy circulating tumor cell (CTC) antibody-based systems have been ineffective in RCC due to low expression of epithelial markers on the CTCs. Istituto Nazionale Tumori di Milano compared the performance of a Parsortix-based approach with a leading alternative CTC system. The Parsortix system was combined with a single cell picking system so that individual CTCs could for the first time, in this tumor type, be harvested and then analysed to assess the heterogeneity of the CTCs.

The Parsortix system greatly out-performed the alternative approach and, being a marker-independent approach for CTC enrichment, it was described in the publication as being "instrumental for increasing CTC detection and for being able to separately identify the sub-populations by immunostaining".

The pilot study suggested that even the presence of a single CTC in a blood sample prior to treatment may predict a reduced progression free survival.

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/.

Dr Vera Cappelletti, Group Leader, Istituto Nazionale Tumori di Milano, Milano, Italy, commented:

"There is a major unmet clinical need in renal cell carcinoma for personalised treatment decisions. We hope that this original work will pave the way for further investigation of how Parsortix can be used to benefit patients with tumor types characterised by low expression of epithelial markers, such as renal cell cancer."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"This publication adds to the body of evidence demonstrating the strong advantages of the Parsortix system identifying new potential uses of the system to improve the care of cancer patients."

As previously announced, following a Q-Submission meeting in January with the US Food and Drug Administration (FDA), ANGLE is now progressing a full De Novo FDA Submission with the prospect of FDA clearance in Q3 CY20, albeit the outcome and timing of the FDA regulatory decision is entirely dependent on the FDA's review and response to the Company's submission.

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 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 29 peer-reviewed publications and numerous publicly available posters, available on our website.