Angle Regulatory News (AGL)

ANGLE plc ("the Company")

INDEPENDENT data PUBLISHED showing CAPABILITY of Parsortix system to capture a single cancer cell in A blood sample for analysis

Research confirms high performance of the Parsortix system to isolate CTCs for downstream analysis of over 2,500 cancer related genes

Gene transcripts detected at high levels of sensitivity

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that independent data from researchers at The University of Texas MD Anderson Cancer Center, published in the peer reviewed journal PLOS ONE, demonstrates the performance of ANGLE's Parsortix® system in tandem with multiple downstream molecular characterisation of circulating tumour cells (CTCs).

The study used blood from healthy volunteers spiked with cancer cells from five breast cancer cell lines and one lung cancer cell line to evaluate the linearity, sensitivity, and specificity of the Parsortix system in combination with three downstream techniques for the molecular characterisation of CTCs.

The Parsortix system demonstrated strong linearity suggesting that a patient sample would reflect the frequency of CTCs in the patient's blood. Furthermore, the Parsortix system was shown to be capable of isolating a single CTC spiked into 5mL of blood. This is significant given the rarity of CTCs and the prognostic significance of even a single CTC during adjuvant treatment of breast cancer.

Using gene expression analysis methods (qRT-PCR), the authors detected gene transcripts at high sensitivity from as few as five spiked cancer cells or less. In addition, the HTG EdgeSeq nuclease protection assay, was able to profile RNA expression of over 2,500 cancer-related genes from the Parsortix system enriched cells. Such downstream analysis has the potential to provide actionable clinical insight and personalised medicine with corresponding targeted therapies as exemplified in this study by quantification of HER2 and PD-L1.

Whilst CTC enumeration is highly prognostic, molecular characterisation of CTCs has the potential to inform individualised treatment strategies and provides a repeatable minimally invasive means to monitor disease and provide targeted treatment over time. This study provides further evidence that the Parsortix system is able to capture and harvest a variety of CTCs, irrespective of their surface antigens, for downstream molecular analysis. Critically, unlike the legacy antibody-based CTC system, the Parsortix system was able to isolate and harvest mesenchymal CTCs which are known to have prognostic significance and metastatic propensity.

Breast cancer is the most frequently diagnosed cancer in women with 2 million cases diagnosed globally and 240,000 cases diagnosed each year in the US. Every tumour evolves differently with time and treatment, bringing about the need for longitudinal patient monitoring. CTCs as a liquid biopsy, provides for minimally invasive, real-time monitoring of cancer patients, giving comprehensive insight into clonal evolution and the potential to provide actionable information for targeted therapy.

MD Anderson Professor and Senior Author James M. Reuben, Ph.D., M.B.A, commented:

"Here we validated the ability of the Parsortix system to isolate and harvest small numbers of cultured cells spiked into healthy donor blood in combination with downstream molecular characterisation. Harvest of captured rare cells by the Parsortix system followed by analysis using the HTG EdgeSeq assay offers the potential for multimodal characterisation of CTCs, which could be highly advantageous in clinical decision making. Furthermore, molecular characterisation of CTCs, as demonstrated in this study, has potential for the development of minimally-invasive diagnostics."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"This study demonstrates the key capabilities of the Parsortix system to isolate CTCs for multiple forms of molecular analysis and the potential for the future development of clinical diagnostics to guide individualised treatment strategies. It also further exemplifies the utility of the Parsortix system in isolating breast cancer CTCs, which is the focus for ANGLE's FDA submission made in September 2020 and currently under substantive review by the FDA."

The research, which has been published in the peer-reviewed journal PLOS ONE, may be accessed via https://angleplc.com/library/publications/

Dr. Reuben receives research support from ANGLE, and he is compensated as a member of its Scientific Advisory Board. This financial relationship has been disclosed to MD Anderson's Conflict of Interest Committee.

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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 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 programme 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 37 peer-reviewed publications and numerous publicly available posters, available on our website.