Angle Regulatory News (AGL)

ANGLE plc ("the Company")

Prostate Cancer UK FUNDs new study using Parsortix

Research into the use of Parsortix-based CTC blood test to assess whether prostate cancer patients require prostatectomy surgery

Potential for a new standard of care in an area of high unmet medical need

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that Prostate Cancer UK has approved funding for a significant clinical study at Barts Cancer Institute, Queen Mary University of London. The study will investigate the use of the Parsortix® system to isolate circulating tumour cells (CTCs) as a predictor of future disease recurrence. Assessment of whether prostate cancer is likely to progress, if this can be done reliably, may have a major bearing on whether radical prostatectomy surgery is the most appropriate treatment choice.

The trial is being funded by a £750,000 grant from Prostate Cancer UK and will follow 200 men with localised prostate cancer over five years. The aim of the study is to see whether the presence of mesenchymal CTCs and CTC clusters in peripheral blood, assessed using the Parsortix system, can predict whether the cancer will eventually spread. The study has been designed and will be conducted by Barts Cancer Institute and is being funded by Prostate Cancer UK, both independently from ANGLE. ANGLE has agreed to provide support for the study through the provision of Parsortix instruments, cassettes and reagents.

The study will enrol patients who are due to have radical prostatectomy surgery and will track them during and after treatment. The researchers will take a blood sample before and at regular intervals after the surgery and process the samples using the Parsortix system seeking to identify those patients where disease progression subsequently occurs. The design of this study has been informed by earlier pilot studies independently conducted at Barts Cancer Institute using the Parsortix system.

The trial is blinded, so the doctors treating the patients will not know the outcome of the blood tests. If the Parsortix system can be used to provide a predictive assessment of disease progression despite radical prostatectomy, it could have a significant impact on how prostate cancer is treated, making it easier for doctors to choose the correct and most effective treatment option.

Prostate cancer is the leading cause of cancer in men with 1 in 8 men diagnosed in their lifetime. In the UK more than 47,500 men are diagnosed with prostate cancer each year and a further 400,000 are living with and after prostate cancer. At least 60% of prostate cancers diagnosed are indolent and unlikely to cause harm during a patient's lifetime. Nonetheless many men will undergo radical prostatectomy which is associated with significant harms including urinary incontinence and erectile dysfunction. There is equal risk associated with undertreatment of aggressive disease and more than 11,500 men, or one man every 45 minutes dies from prostate cancer in the UK each year. Liquid biopsy offers the potential for a much safer, cost-effective diagnosis, active surveillance and, following diagnosis, the ability to offer longitudinal monitoring and up to date targeted treatment selection.

Yong-Jie Lu, lead researcher of the study and Professor of Molecular Oncology at Barts Cancer Institute, Queen Mary University of London, commented:

"If our hypothesis is correct, we hope that this blood test will become the future standard of care for these patients. Patients with localised prostate cancer will be treated more efficiently and in a more personalised way, rather than surgically removing the prostate and just waiting to see what happens. Doctors will have more information about whether the cancer has really spread or not, based on this test meaning patients won't be over or under-treated."

Dr Hayley Luxton, Research Impact Manager at Prostate Cancer UK, commented:

"We are delighted to support this trial which has the potential to inform treatment decisions and improve outcomes for men living with prostate cancer. Prostate cancer is the most common cancer in men, killing 11,500 people each year in the UK. Being able to identify aggressive cancer beforehand will help to ensure that men are receiving the right treatment at the right time."

ANGLE Founder and Chief Executive, Andrew Newland, added:

"We are pleased that Barts Cancer Institute is progressing investigation of clinical application of the Parsortix system in prostate cancer and, independent form the Company, has secured substantial funding from Prostate Cancer UK. Our aim is that the Parsortix system will be widely adopted by third parties seeking from their own initiative and funding to develop many and varied uses of the Parsortix system to support cancer patients."

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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 a 200 patient clinical verification study has now completed enrolment.

ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEADTM 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 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 59 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 Parsortix in cancer drug trials and, once the laboratories are accredited and tests validated, will provide Laboratory Developed Tests (LDTs) for patient management.