Angle Regulatory News (AGL)

ANGLE plc ("the Company")

GLOBAL LAUNCH OF CLINICAL SERVICES LABORATORIES

Delivering on strategy to accelerate commercialisation of the Parsortix system and act as a demonstrator to support product deployment

UK and US clinical laboratories now open and ready to provide CTC analysis services and discussions with pharmaceutical industry customers ongoing

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that it has completed the fitout and staffing of its clinical services laboratories in Guildford UK, and Plymouth Meeting PA, United States. This launch comes ahead of schedule with the US laboratory being completed sooner than anticipated and the UK laboratory opening in line with anticipated timescales. Together, these laboratories will allow ANGLE to accelerate the commercial deployment of the Parsortix® system by offering services to pharmaceutical and biotech customers for use in cancer drug clinical trials and, once the laboratories are accredited and tests validated, through the provision of Laboratory Developed Tests (LDTs) for patient care.

ANGLE's sample to answer liquid biopsy solution via a simple blood test enables longitudinal monitoring of patients during drug trials (before, during and after drug intervention) which is not possible with tissue biopsy. This represents a significant market opportunity for ANGLE. In a single subset of this market, there are over 2,000 PD-L1/PD-1 interventional trials registered on clinicaltrials.gov, enrolling over 300,000 patients, which would be potential targets for ANGLE's pharma services business.

ANGLE is targeting future clinical studies for adoption of the Parsortix system and has developed service capabilities in the United Kingdom and the United States to process samples on a commercial scale as part of global pharma trials. ANGLE has already established dialogue with prospective customers and collaborators for the deployment of CTC liquid biopsy analysis in cancer drug trials, with a number of these conversations at an advanced stage.

Both the UK and US laboratories will seek ISO15189 accreditation and the US laboratory will also seek Clinical Laboratory Improvement Amendments (CLIA) accreditation, which will allow them to market LDTs for clinical use. Given the extensive clinical work already completed with the Ovarian Cancer Pelvic Mass Triage assay, it is anticipated that this will be ANGLE's first LDT to market.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"The new clinical services laboratories are an important element in the Company's commercial strategy and we are pleased to launch the global offering ahead of schedule. This will accelerate commercialisation of the Parsortix system and act as a demonstrator to support product deployment. As well as working with pharmaceutical company customers directly, we are keen to work with contract research organisations both as a white label service and, when they wish to deploy the tests internally, by supplying Parsortix systems so that they can directly offer their own CTC services for cancer drug trials. This will enable us to scale the commercial use of the Parsortix system in this large market. We are in advanced discussions with potential customers and we look forward to updating the market on the first contracts in due course."

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 https://angleplc.com/investor-relations/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 an intact cell they allow DNA, RNA and protein analysis and thus provide comparable analysis to a tissue biopsy. 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. In addition, the live CTCs harvested can be cultured, which offers the potential for testing 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.

The Parsortix system has a CE Mark in Europe for the indicated use and, in the United States, a De Novo Submission has been made to FDA for the Parsortix® PC1 system seeking FDA clearance with Class II Classification for use with metastatic breast cancer patients. FDA clearance is seen as the global standard. ANGLE is seeking to be the first ever FDA cleared system for harvesting CTCs for subsequent analysis.

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