First large-scale pharma services contract secured

ANGLE plc ("the Company")

FIRST LARGE-SCALE PHARMA SERVICES CONTRACT SECURED

Contract worth up to US$1.2 million with potential for further contracts from the same customer

Parsortix system being utilised in cancer drug trials for liquid biopsy longitudinal monitoring which is not possible with tissue biopsies

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that the Company has secured its first large-scale pharma services contract. The customer, a pharma company with numerous cancer drugs under development and revenues exceeding US$1 billion per annum, has selected ANGLE's Parsortix^® system to undertake longitudinal monitoring (i.e. before, during and after drug intervention) of patients in three separate global clinical trials in prostate cancer and other locally advanced and metastatic solid tumours.    

The contract is expected to be worth up to US$1.2 million over some 18 months.  The work relates to a large Phase III prostate cancer study and two smaller Phase I studies.  The Phase I studies, if successful, could progress to larger Phase II studies and, if successful, much larger Phase III studies. 

The services cover the capture, harvest and analysis of circulating tumor cells (CTCs) and CTC clusters. Samples are being shipped from multiple study centres to ANGLE's clinical laboratories in the UK and United States for analysis using the Parsortix system.

The contract represents the first large-scale adoption of the Parsortix system for processing patient blood samples to help inform decision making in cancer drug trials. Importantly, the customer recognises the advantage in capturing mesenchymal as well as epithelial cancer cells and the importance that CTC clusters as well as single CTCs may have in the progression of disease, metastasis, and drug resistance.

The Parsortix liquid biopsy has particular advantages in capturing intact cancer cells including mesenchymal cells and clusters and provides the opportunity for longitudinal testing in a clinical setting, which is not possible with tissue biopsy.  ANGLE believes that longitudinal monitoring of CTCs will prove highly attractive to the pharma industry looking for new insights in cancer drug trials.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are delighted to have contracted with a pharma company developing numerous cancer drugs and look forward to working closely with them on their trials. ANGLE believes that there is a substantial business opportunity in providing services to pharma and biotech customers to support cancer drug trials. This contract demonstrates that our investment in clinical laboratories and a pharma services business, a key use of proceeds from our fundraising in October 2020, is already delivering. We look forward to announcing further progress on the expansion of this important business area for ANGLE 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 may 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 of a patient's tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor 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.

ANGLE has established clinical services laboratories in the UK and USA to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services to pharmaceutical and biotech customers for use of the Parsortix system in cancer drug trials and, once the laboratories are accredited, and tests validated, will provide Laboratory Developed Tests (LDTs) for patient management.