Angle Regulatory News (AGL)

ANGLE plc ("the Company")

ANGLE'S PARSORTIX SYSTEM SHOWCASED IN POSTER PRESENTATIONS AT LEADING CANCER CONFERENCE

Publication of study results demonstrating the capabilities of two new assays in clinical samples at AACR 2021

Immunotherapy assay enables determination of PD-L1 status in significant proportion of patients and could guide personalised treatment selection

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that two poster presentations showcasing the Parsortix® system are being presented at the American Association for Cancer Research Conference (AACR) 2021, being held as a virtual meeting on 10-15 April 2021 and then 17-21 May 2021. These posters present findings from key studies undertaken as part of ANGLE's clinical development programme.

The first poster, "Mesenchymal markers: the new avenue for circulating tumour cells detection", reports on the performance of ANGLE's new epithelial-to-mesenchymal transition (EMT) assay to isolate and identify both epithelial and mesenchymal circulating tumor cells (CTCs) in 47 metastatic breast cancer (MBC) and 48 non-small cell lung cancer (NSCLC) patients.

Unlike tissue biopsy, a liquid biopsy harvesting CTCs from peripheral blood allows the routine, repeat testing and characterisation of cancer at genetic (DNA), transcriptional (RNA) and protein levels. Most CTC isolation systems, including the market leader, are based on epitope-dependent CTC capture using epithelial markers. However, it is known that tumour cells can undergo EMT resulting in these clinically relevant cells being missed by epitope-dependent systems. ANGLE's Parsortix system addresses this major limitation in other systems by its epitope-independent proprietary approach to capture all phenotypes of cancer cell in the blood circulation.

This study highlighted the importance of the inclusion of mesenchymal markers into CTC characterisation, as 25-38% of CTCs captured by the Parsortix system expressed mesenchymal markers which would have been missed with an epithelial-only based approach. In addition, 59%-74% of CTCs had both epithelial and mesenchymal markers and were therefore undergoing EMT whilst only 1-3% of CTCs were purely epithelial.

ANGLE's EMT assay showed a high degree of analytical sensitivity (97-98%) and specificity (96-98%) in spiking experiments and these findings were confirmed in patient samples (96% specificity).

The second poster "Investigation of PD-L1 expression in circulating tumour cells isolated using the Parsortix system in metastatic lung and breast cancer patients" showcases ANGLE's programmed death-ligand 1 (PD-L1) assay.

PD-L1 is a protein thought to play a major role in immuno-oncology, allowing many cancers to evade the host immune system when upregulated. Immunotherapy drugs known as PD-L1 inhibitors are showing excellent therapeutic results in multiple cancers for some patients. However, these drugs are expensive at some $170,000 per treatment and only work in ~30% of patients highlighting the need for companion diagnostics to enable targeted patient selection. The measurement of PD-L1 expression from CTCs offers the potential to identify patients who might respond to such immunotherapy drugs and, importantly, to monitor patients on these therapies using a drug-specific target.

ANGLE's study in 17 MBC and 18 metastatic NSCLC patients found CTCs in 70% and 55% of patients respectively. No CTCs were found in 17 healthy volunteers, confirming high specificity. The PD-L1 assay allowed for definitive identification of PD-L1 positive and PD-L1 negative status in a high proportion of patients with CTCs (72% of MBC and 60% of NSCLC) with the remaining patients having a mix of PD-L1 positive and PD-L1 negative CTCs. This lays the groundwork for the further refinement of the assay to enable dynamic PD-L1 monitoring in patients during the course of their treatment and follow-up.

The successful detection of PD-L1 CTC status in MBC and NSCLC opens the potential for collaboration with leading pharma companies with immunotherapy drugs in development. 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.

The global PD-L1 inhibitor market is estimated to be valued at US$22bn and is growing at >40% per annum.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are pleased to present promising data showcasing new "sample-to-answer" applications for ANGLE's Parsortix system at AACR, a leading international cancer conference. Future drug trials of immune checkpoint inhibitors will be targets for adoption of the Parsortix PD-L1 assay and ANGLE is developing a pharma services capability to process these types of trial samples for multiple such biomarkers on a commercial scale.

ANGLE recently launched clinical services laboratories in the UK and United States, and is in advanced discussions with potential customers for the deployment of the Parsortix system in cancer drug clinical trials. We look forward to updating the market on the first contracts in due course."

Both published posters are available at https://angleplc.com/library/publications/.

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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.