Angle Regulatory News (AGL)

ANGLE plc ("the Company")

BLOOD DONATIONS RECOMMENCED FOR FDA ANALYTICAL STUDIES

Ovarian cancer study patient enrolment recommenced

All aspects of ANGLE business operational again

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that blood donations have recommenced in support of ANGLE's FDA analytical studies and for patient enrolment in its pivotal ovarian cancer study.

As announced on 31 March 2020, completion of ANGLE's remaining analytical studies in support of its US Food and Drug Administration (FDA) submission for Parsortix® had to be ceased as a result of UK Government COVID-19 lock down measures preventing blood donations from healthy volunteers. Similar restrictions in the United States impacted patient enrolment at University of Rochester Medical Centre, New York for our ovarian cancer study there.

US FDA Submission

In response to UK Government relaxation of the COVID-19 lock down rules and extensive work by ANGLE to address new health and safety guidelines, complete required risk assessments, ensure compliance with our formal ethics approval for drawing blood, and meet other ethical, insurance and legal considerations, blood donations from healthy volunteers are again being processed at ANGLE's Guildford, UK facility. The work undertaken by ANGLE in support of this has been extensive and included re-purposing part of our facilities to provide physical segregation, establishing double shift working to enable social distancing, and instituting PPE and other additional safety protocols to protect staff and donors alike.

The blood samples are used for various development activities, the most important of which is completion of the remaining analytical studies in support of ANGLE's submission to the FDA; where we are seeking the first ever FDA regulatory clearance for a simple blood test to harvest cancer cells for analysis, initially in metastatic breast cancer.

The FDA analytical studies have specific requirements for healthy volunteer blood donations, which must be met to be valid for the FDA process. These include:

· using fresh blood processed within 8 hours of blood draw;

· ensuring the appropriate demographic of donors - we have a particular need for women over the age of 50;

· ensuring blood donations are available at the right time of day - we need blood donors all day from 6am onwards to meet the new double shift requirement that we have implemented;

· obtaining blood donations in sufficient numbers to be confident of successful completion of the required FDA analytical studies - these cannot be completed in a piece-meal fashion and have to be completed according to strict analytical protocols in order to be valid for their purpose.

Enrolling willing and available healthy blood volunteers is subject to a degree of uncertainty at present and, in addition, there is a risk that UK Government may re-tighten COVID-19 lock down restrictions. We cannot be certain of the timescale for completion of the necessary remaining FDA work and its timely review, where required, by the participating US cancer centres whose availability is impacted not only by US Government lock down restrictions but also by a back-log of clinical cases that now have to be prioritised. We hope to complete the necessary work and make our submission to the FDA during the coming quarter (Q3 CY20) although note the inherent uncertainties.

Ovarian cancer test - pelvic mass triage test

The University of Rochester Medical Center Wilmot Cancer Institute, New York (Rochester) has recommenced patient enrolment for ANGLE's ovarian cancer clinical verification study.

The speed of patient enrolment continues to remain outside of the Company's control and is likely to be reduced from normal by COVID-19 related matters (reduced hospital capacity due to social distancing, hygiene measures etc.) and related issues such as the competing need for resources. ANGLE is working towards completing the study as fast as possible and, taking all the known factors into account, but excluding a potential second wave of COVID-19 and further US Government lock down measures affecting patient enrolment, expects that patient enrolment will be complete by the end of the calendar year.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"I am delighted that both ANGLE's key programmes - working towards FDA clearance in metastatic breast cancer and the development of our ovarian cancer detection test - are now back in progress. This has taken a major effort by all our team and collaborators and I thank them for their work to enable this. We are looking forward to making our FDA submission and completing our ovarian cancer study as soon as possible.

The COVID-19 lock down has highlighted major flaws in cancer diagnosis and treatment that are overly dependent on surgical intervention. ANGLE is aiming to help address these issues through a simple blood test that can even be administered in the patient's own home. We see this as a potential future contribution to the many issues arising from the COVID-19 lock down for cancer patients and thank our shareholders for their patience and understanding whilst some of our work has been delayed during lock down."

For further information:

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

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 cells of interest to users in a format suitable for multiple types of downstream analyses. The system uses 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 a complete cell, they allow DNA, RNA and protein analysis, and the live cells harvested can also be cultured. The Parsortix technology is the subject of 24 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 submission to FDA for clearance is in process for the United States using results from two separate clinical studies of over 250 metastatic breast cancer patients and associated analytical studies. 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 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 (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 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 33 peer-reviewed publications and numerous publicly available posters, available on our website.