ANGLE plc

06/05/2019 | Press release | Distributed by Public on 06/05/2019 00:04

Completion of Ovarian Cancer Pre-Study

For immediate release

5 June 2019

ANGLE plc ('the Company')

SUCCESSFUL COMPLETION OF OVARIAN CANCER PRE-STUDY

Pre-study demonstrates ANGLE's optimised sample-to-answer molecular solution with patient samples

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that the first phase of its ovarian cancer clinical verification study ('the pre-study') has reported positive results.

The pre-study, undertaken by Dr. Richard Moore and colleagues at the University of Rochester Medical Center Wilmot Cancer Institute (Rochester), was designed to evaluate the use of ANGLE's modified and further optimised ParsortixTMand HyCEADTMZiplex®platforms as a simple blood test to detect the presence of ovarian cancer in women with a pelvic mass, in a clinical setting and with clinical samples.

The pre-study comprised the evaluation of blood samples from 26 Stage III/IV ovarian cancer patients and 28 healthy volunteers using ANGLE's sample-to-answer molecular solution: Parsortix harvested circulating tumour cells and HyCEAD-Ziplex performed multiplex RNA expression analysis of those cells. The observed discrimination between cancer patients and healthy volunteers suggests the potential for both high sensitivity (correctly detecting cancer) and high specificity (correctly detecting no cancer i.e. low false positives).

The pre-study results demonstrate that the optimisation of the sample-to-answer molecular solution has been successful, paving the way to initiate the 200 subject ovarian cancer clinical verification study of patients who are presenting with a pelvic mass and scheduled for surgery. A positive outcome from the clinical verification study would support ANGLE's plans to launch a clinical assay for the detection of ovarian cancer in women with an abnormal pelvic mass.

This study is expected to start in early Q3 CY19 and is projected to complete in Q1 CY20. Project timelines assume a similar enrolment rate to the previous 200 patient pelvic mass study conducted by the same clinical centre but patient enrolment is outside of the Company's control.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

'The performance of ANGLE's optimised sample-to-answer molecular solution for ovarian cancer in the pre-study is encouraging. We are excited about progressing the full clinical verification study which will help support the launch of a clinical assay at a clinical laboratory and/or via a commercial partnership.'

Further information

Approximately 5% to 10% of women will be diagnosed with a pelvic mass during their lifetime, with 13% to 21% of these women being subsequently diagnosed with ovarian cancer. A test to detect circulating tumor cells in the blood and hence ovarian cancer prior to surgery would enable women to be triaged to appropriate surgical procedures improving patient outcomes whilst at the same time reducing overall healthcare costs. ANGLE estimates that the global market size for this clinical application is worth US$1 billion per annum.

Results for ANGLE's previous 200-subject ovarian cancer study with Rochester were presented at The Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer in New Orleans in March 2018. The assay (combining the Parsortix and HyCEAD Ziplex systems) achieved a high degree of accuracy for the prediction of the presence of ovarian cancer, with a ROC-AUC1 of 95.1%. The novel test achieved higher sensitivity and specificity than any other test available for the same clinical application. In particular, existing tests suffer from low specificity with a high false positive rate.

For further information ANGLE:

ANGLE plc

+44 (0) 1483 343434

Andrew Newland, Chief Executive

Ian Griffiths, Finance Director

finnCap Ltd (NOMAD and Joint Broker)

Corporate Finance - Carl Holmes, Simon Hicks, Max Bullen-Smith

ECM - Alice Lane, Sunila de Silva

+44 (0)20 7220 0500

WG Partners (Joint Broker)

Nigel Barnes, Nigel Birks, Andrew Craig, Chris Lee

+44 (0) 203 705 9330

FTI Consulting

Simon Conway, Ciara Martin

Matthew Ventimiglia (US)

+44 (0) 203 727 1000

+1 (212) 850 5624

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

For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/

Notes for editors

1. The area under the curve (AUC) for a receiver operating characteristic (ROC) plot, a plot of 1-specificity on the x-axis vs. the sensitivity on the y-axis at each possible threshold for a test's results, is a measure of a diagnostic test's accuracy. The accuracy of the test depends on how well the test separates the two groups being compared into those with the outcome (sensitivity) and those without the outcome (specificity) in question. An AUC of 1 (100%) represents a perfect test while an AUC of 0.5 (50%) represents a worthless test. The traditional academic classification system for ROC-AUCs is 90% to 100% = excellent; 80% to 90% = good; 70% to 80% = fair; 60% to 70% = poor; 50% to 60% = fail. Source: University of Cambridge MRC Unit http://imaging.mrc-cbu.cam.ac.uk/statswiki/FAQ/roc

About Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center Wilmot Cancer Institute https://www.urmc.rochester.edu/people/29638888-richard-g-moore

Dr. Moore comes to UR Medicine from Brown University and Women & Infants Hospital of Rhode Island. A native of Montreal, Quebec, Canada, Dr. Moore graduated from the University of Alberta Medical School in Edmonton. He completed his residency at Eastern Virginia Graduate School of Medicine, where he also served as Administrative Chief Resident. He completed a fellowship in Gynecologic Oncology and Breast Surgery at Women & Infants Hospital/Brown University. Dr. Moore joined the faculty at Women and Infants/Brown University after leaving fellowship. He served as the Associate Director of the Program in Women's Oncology since 2009 and was the Director of the Center for Biomarkers and Emerging Technology as well as the Molecular Therapeutics laboratory.

Dr. Moore is board-certified in gynecologic oncology and is a fellow of the American College of Obstetricians and Gynecologists and a fellow of the American College of Surgeons.

In addition to his clinical interest in ovarian and endometrial cancers, Dr. Moore is recognized internationally as a leading expert on the use of biomarkers to detect ovarian cancer. He led the team that developed the Risk of Ovarian Malignancy Algorithm (ROMA), a test that is cleared for use in Europe and Asia and has been cleared by the U.S. Food and Drug Administration to detect ovarian cancer in women who have an ovarian cyst or pelvic mass.

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 (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple downstream subsequent analyses. 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. The Parsortix technology is the subject of 21 granted patents in Europe, the United States, Canada, India, China, Japan and Australia with three extensive families of patents are being progressed worldwide. The system is based on a microfluidic device that captures 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 already undertaken 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 (ROC-AUC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimisation, and is currently in the process of a 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 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 (ROC-AUC) 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 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 20 peer-reviewed publications and numerous publicly available posters, available on our website.