Angle Regulatory News (AGL)

ANGLE plc ("the Company")

CUSTOMER DEVELOPS NEW APPLICATION FOR PARSORTIX SYSTEM IN CANCER LYMPH NODE ANALYSIS

Potential for Parsortix system to improve laboratory efficiency, reduce costs and improve medical decision-making and patient care

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that its ParsortixTM system has been successfully used to improve the workflows and sensitivity of lymph node analysis in melanoma.

The research, led by Dr Bernhard Polzer at the Fraunhofer Institute for Toxicology and Experimental Medicine (Regensburg, Germany), has been published as a peer-reviewed publication in the International Journal of Cancer and is available at https://angleplc.com/library/publications/.

The need to investigate the lymph node is crucial in melanoma as patients whose cancer has advanced need supplementary treatment beyond simple excision and late stage melanoma is very aggressive. Fraunhofer have developed a new approach to lymph node analysis using Parsortix which improves the process whilst at the same time reducing costs.

A key area of investigation in melanoma, and several other cancers including head & neck cancer and lung cancer, is to determine whether the cancer has spread to the lymph nodes to determine the "Stage" of the cancer and inform treatment decisions. Standard clinical practice is to resect (cut out) the nearest sentinel lymph node to the melanoma. The lymph node is then embedded in FFPE (Formalin-Fixed Paraffin-Embedded) as a tissue biopsy and slices of the FFPE are stained and examined for the presence of metastasis or single DTCs (disseminated tumor cells). If tumor cells are found then the patient is identified as Stage 3 and will be given chemotherapy in addition to having their melanoma excised. This is a key approach in the treatment decision process for melanoma and applied to all patients.

However, there are a number of known problems with the current approach, which Fraunhofer has addressed using Parsortix to harvest DTCs from lymph node material. These are as follows:

1) There can be very few DTCs in the lymph node and the FFPE process only investigates a small proportion of the tissue. Consequently Fraunhofer believe that the DTCs can be missed in up to 50% of patients, who are likely to be incorrectly staged. This can be improved by mechanical disaggregation of the lymph node to a single cell suspension allowing analysis of the complete lymph node.

2) The evaluation of the single cell suspension under the microscope requires multiple microscope slides and is time consuming and expensive in terms of laboratory technician time. The Parsortix system can process the entire lymph node harvesting all the DTCs that may be present and reducing the number of false negatives. This greatly enriches the DTCs so that only one microscope slide is needed making it quicker and easier to analyse.

3) Unless there are many DTCs present, with the FFPE approach it can be difficult to undertake molecular analysis to detect the presence of BRAF and other molecular markers. As a consequence, patients that are BRAF positive in the lymph node DTCs may not receive appropriately targeted treatment (BRAF inhibitors such as Vemurafenib developed by Roche Genentech). The Parsortix system provides the DTCs in a form where molecular analysis can be undertaken not just for BRAF but for other relevant genes.

Dr Bernhard Polzer, Group leader Molecular Diagnostics, Division of Personalized Tumor Therapy, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM-Regensburg, Germany, commented:

"The new approach using the Parsortix system streamlines the analysis of lymph nodes in melanoma for a higher sensitivity of detecting the spread of cancer to the lymph node and greatly improving the ability to undertake key molecular analysis on the cancer. It is an added benefit that it also facilitates single cell analysis reducing costs. We previously tried other CTC systems including antibody-based and membrane systems but these were not suitable for this process."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"This is another example of our leveraged approach with research customers delivering new applications for Parsortix. There is now the potential for the Parsortix system to be adopted as a standard approach for analysing lymph nodes, which is a requirement for all patients diagnosed with melanoma and several other cancer types."

For further information ANGLE:

For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/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 an epitope-independent 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 ParsortixTM system and it enables a liquid biopsy (simple blood test) to be used to provide the cells of interest. CTCs enable the complete picture of a cancer to be seen as they allow DNA, RNA and protein analysis and the live cells harvested can be cultured. Parsortix is the subject of 21 granted patents in Europe, the United States, Canada, India, China, Japan and Australia and three extensive families of patents are being progressed worldwide. The system is based on a microfluidic device that captures live cells based on a combination of their size and compressibility. The Parsortix system has a CE Mark in Europe for the indicated use and FDA clearance is in process for the United States with a 400 subject study in metastatic breast cancer. ANGLE is seeking to be the first ever FDA cleared CTC harvesting system and only the third ever FDA cleared liquid biopsy test. ANGLE has undertaken 400 subject clinical studies in an ovarian cancer pelvic mass triage test that achieved best in class accuracy (ROC-AUC) of 95.1% and is being optimised.

ANGLE's analysis technology for proteins and nucleic acids of all types is called the HyCEAD 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 allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. The HyCEAD Ziplex system 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 the 95.1% accuracy.

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 QIAGEN, Abbott and Philips, 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 15 peer-reviewed publications and 23 publicly available posters, available on our website.