Contract secured for bespoke assay development

ANGLE plc ("the Company")

CONTRACT SECURED WITH NEW PHARMA SERVICES CUSTOMER FOR BESPOKE ASSAY DEVELOPMENT

ANGLE to develop two custom CTC assays to look at biomarkers of DNA damage repair 

Validated assays expected to be used for longitudinal analysis in clinical trial

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that it has agreed a pharma services contract with another new customer for its recently established pharma services business. ANGLE has been selected to develop immunofluorescence (IF) assays using its Parsortix^® system to detect two specific protein markers expressed by circulating tumour cells (CTCs) and implicated in DNA damage repair (DDR), an increasing area of focus for oncology drug development. The new customer is a well-funded clinical stage development company with established commercialisation agreements with multiple global pharma companies.  

As part of the contract, ANGLE will develop the two assays to detect the target proteins in four hard-to-treat cancers: triple negative breast cancer, prostate cancer (including metastatic and/or castration resistant), ovarian cancer (including high grade) and pancreatic cancer. The assays will be developed in ANGLE's UK R&D facility before being validated in ANGLE's clinical laboratories.

The first phase of work agreed covers the initial assay development and validation contract generating revenues of c. US$ 400,000 over a 12 month period.  Assuming a successful outcome, the customer expects the assays to be utilised in a clinical trial with study sites in the United States and Europe, planned to commence in H2 2022. The clinical trial phase will incorporate longitudinal analysis of patient samples (for example before, during and after treatment with the investigational drug) and is expected to generate further significant revenues for ANGLE.  The same customer also has other separate assay development projects, which it is discussing with ANGLE.

The incorporation of bespoke assay development as a first phase in pharma services is a major development for ANGLE, which is expected to significantly increase the attraction of the Parsortix CTC analysis offering, as pharma clients can look at proteins on CTCs which directly align with the mechanism of operation of their drug under investigation. 

Once developed, the new assays will remain in the ownership of ANGLE and be added to ANGLE's menu of pre-developed tests that can be offered to other pharma customers.  As in this case, pharma companies are commonly interested in investigating protein markers on actual cancer cells.  These cannot be investigated using the alternative liquid biopsy approach ctDNA (fragments of dead cancer cells) since protein cannot be measured on ctDNA.  Tissue biopsies provide cancer cells but cannot be used for longitudinal monitoring since only a single time point is usually possible with tissue biopsy.  Consequently, pharma companies are unable to access this analysis without analysing CTCs.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are delighted to have secured our first assay development contract so soon after launching this service. Research by leading cancer centres has demonstrated the utility of the Parsortix platform in detecting novel drug targets expressed by CTCs and this contract to develop assays against new targets of interest provides further endorsement of our technology. DNA damage repair (DDR) is a growing area of interest in new drug development and assay development.  The new assays will provide an important addition to our pharma services menu alongside our existing capabilities in PD-L1 for immunotherapy."

For further information ANGLE:

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 ("MAR"), and is disclosed in accordance with the Company's obligations under Article 17 of MAR.

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 46 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.