FIRST SUBJECTS ENROLLED IN OVARIAN CANCER STUDY

ANGLE plc ("the Company")

FIRST SUBJECTS ENROLLED IN OVARIAN CANCER CLINICAL VERIFICATION STUDY

Study to confirm the combination of ANGLE's Parsortix system with its new HyCEAD Ziplex platform as sample-to-answer for accurate pelvic mass triage

Study expected to complete in Q1 CY2020

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that ethics approval has been obtained from the University of Rochester Medical Center Wilmot Cancer Institute for its ovarian cancer clinical verification study ("the Study").

The first subjects have already been enrolled into the Study, which comprises a 70-subject pre-study followed by a 200-subject clinical study, evaluating the use of ANGLE's modified and further optimised Parsortix^TM and HyCEAD^TM Ziplex^® platforms as a simple blood test to detect the presence of ovarian cancer in women with a pelvic mass. The Study is expected to complete in Q1 CY2020.

Since its acquisition of the HyCEAD Ziplex downstream analysis platform in November 2017, ANGLE has undertaken extensive optimisation of both the HyCEAD Ziplex platform and its combination with the Parsortix system to provide an assay predictive of ovarian cancer risk.  A detailed market review has been completed to identify key user requirements for adoption of the test and work has been completed to address these identified user requirements with key improvements including:

·     improved analytical sensitivity of the HyCEAD Ziplex platform enabling the detection of a single cancer cell harvested by the Parsortix system from a 10ml blood sample

·     incorporation of assay controls and use of fractional sampling to demonstrate reproducibility and reliability of performance

·     development of methods to allow for patient blood sample processing for up to 96 hours after collection without significantly compromising the assay sensitivity, thus opening up the possibility for the test to be offered by large central laboratories with sufficient time for sample transportation.

The entire sample-to-answer process has been analytically validated using contrived samples and is now being tested in the clinical setting.  Testing of the modified and further optimised Parsortix and HyCEAD Ziplex platforms has begun in the pre-study using known ovarian cancer patients and healthy volunteers to confirm the performance of various improvements to the process.  Upon successful completion of the initial testing phase, the blinded, independently controlled 200-subject verification study of the targeted population of pelvic mass patients prior to surgery will begin.  The Study has been designed to evaluate performance of the predictive assay in a new patient cohort and, assuming the initial testing is successful, is expected to complete within 12 months. 

Once the new performance data is available and, assuming comparable results to the previous study, ANGLE intends to use this data in discussions with large clinical laboratories and/or women's health companies to secure a partner for clinical deployment utilising the sales and distribution channels of the partner to scale deployment.  The test has the potential to significantly improve patient outcomes whilst at the same time reducing overall healthcare costs.

Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center Wilmot Cancer Institute, commented:

"The planned 200-subject study is designed to verify the clinical performance of the novel ANGLE ovarian cancer assay in discriminating malignant from benign pelvic masses prior to surgery. The test's high sensitivity and specificity, demonstrated in a previous study presented at the 2018 SGO annual meeting, will help to ensure that women with ovarian cancer get the best possible specialist treatment whilst women with a benign condition will be able to have their treatment locally with the physicians they know."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"The performance of the HyCEAD Ziplex system in conjunction with Parsortix endorses the Company's decision to acquire the platform and opens a wide range of commercial opportunities.  The first clinical application in ovarian cancer is an exemplar with a large opportunity for ANGLE and we are excited about progressing the clinical verification study."

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 University of Rochester Medical Center Wilmot Cancer Institute were presented at The Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer in New Orleans in March 2018.  The assay (combining Parsortix and HyCEAD Ziplex) 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:

This announcement contains inside information.

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.

Dr. Moore will see patients at 125 Lattimore Road, Suite 258 and will perform surgeries at Highland Hospital, which has been awarded the Gold Seal of Approval by the Joint Commission and leads the state in the number of minimally invasive, robotic surgeries for gynecologic cancer performed each year.

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 Parsortix^TM 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 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 already undertaken 400 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 HyCEAD^TM 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 18 peer-reviewed publications and numerous publicly available posters, available on our website.