Potential to prevent breast cancer relapse

ANGLE plc ("the Company")

BREAKTHROUGH RESEARCH SUPPORTS POTENTIAL USE OF PARSORTIX IN PREVENTION OF RELAPSE OF BREAST CANCER PATIENTS IN REMISSION

Parsortix system successfully used to harvest cancer cells "hibernating" in the bone marrow of breast cancer patients

Parsortix enrichment of these cancer cells found to significantly enhance RNA sequencing analysis enabling the identification of clinically relevant biomarkers, which may lead to targeted treatment to eradicate these cells

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce the publication of pivotal research by Washington University School of Medicine, St. Louis, Missouri, United States into the utility of the Parsortix^® system to isolate rare cancer cells present in the bone marrow (known as Disseminated Tumour Cells, or DTCs) of breast cancer patients. Analysis of DTCs in breast cancer patients may help to inform treatment decisions and potentially prevent relapse for patients in remission.

Breast cancer is the most prevalent cancer in women worldwide. There is a lifetime risk of a woman developing breast cancer of some 13%.  In the United States alone, there are approximately 3.7 million women alive previously diagnosed with breast cancer. Despite new treatment options and advances in patient management protocols, some 25% of women previously diagnosed with breast cancer will, often after many years of remission, relapse and die of their cancer within 20 years of diagnosis. 

DTCs "hibernating" in the bone marrow are believed to be the progenitors of distant metastatic cancer relapse when some event, currently not understood, stimulates them to re-enter the blood circulation causing distant metastatic spread of the cancer. There is a critical need to identify and molecularly characterise these rare cells, with the ambition to develop targeted treatments to prevent DTCs progressing to a metastatic site.

The Parsortix system was evaluated alongside multiple other approaches and found to be the most effective for harvesting DTCs, which are highly heterogeneous rare cells. The Parsortix system was able to repeatably achieve a 1,000-fold enrichment of DTCs for gene expression analysis by droplet-digital PCR and significantly enabled single cell RNA sequencing and population-based molecular profiling of these rare cells.

Furthermore, the Parsortix system was found to have several other advantages over alternative approaches investigated including ease of operation, minimal handling of samples and easy recovery of viable cells. The researchers concluded that the Parsortix system will enable further research into the diverse molecular phenotypes of DTCs, supporting the development of novel treatments and treatment protocols to eradicate these cells to prevent distant disease development in breast cancer patients.

The research has been published as a peer-reviewed publication PLoS One and can be accessed via https://angleplc.com/library/publications/.  

Professor Rebecca Aft from the Department of Surgery, Washington University School of Medicine, St. Louis, Missouri, United States commented:

"We report that the Parsortix system, an automated size and flow-based CTC enrichment platform can be successfully used to enrich DTCs from the bone marrow of breast cancer patients. We demonstrated recovery, enrichment, and downstream molecular analysis like that achieved with blood. We found that enriched DTCs were sufficient in number and viability to serve as a template for single cell RNA sequencing analysis and biologically and clinically relevant breast cancer expression profiles were detected. The Parsortix system now makes it possible to molecularly interrogate heterogeneous (including EpCAM negative or low EpCAM expression) DTCs using this system and uncover important new biomarkers that could provide a basis for targeted treatments."

Mark Watson, Associate Professor, Pathology and Immunology, Div. of Laboratory and Genomic Medicine, Washington University School of Medicine, St. Louis, Missouri, United States added:

"It is our most fervent research objective to demonstrate with rigorous, peer-reviewed research data that a system such as Parsortix could be used to routinely enrich, identify, and classify occult tumor cells in the bone marrow of breast cancer patients to develop personalized, long-term therapeutic strategies to prevent disease progression and mitigate distant metastatic spread for improved long-term survival."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"DTC presence in bone marrow has been shown in multiple studies to be predictive of clinical relapse. The risk of recurrence varies significantly by cancer type and many cancer survivors fear recurrence. Investigation and eradication of DTCs could greatly reduce the risk of relapse for breast cancer patients in remission. This work from the Washington University School of Medicine may provide a new avenue for the treatment of cancer and we are delighted that our Parsortix system is enabling this new approach."

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The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2015.

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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 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 44 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.