Angle Regulatory News (AGL)

ANGLE plc ("the Company")

GROUND-BREAKING WORK DEMONSTRATES POTENTIAL FOR PARSORTIXTM LIQUID BIOPSY TO REPLACE SOLID BIOPSY IN METASTATIC BREAST CANCER

Direct comparison of a simple blood test processed with the Parsortix system with invasive solid biopsy of the metastatic site delivers comprehensive gene expression analysis

Leading US cancer center, the University of Southern California Norris Comprehensive Cancer Center presents data at the world-renowned San Antonio Breast Cancer Symposium

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that the University of Southern California (USC) Norris Comprehensive Cancer Center yesterday presented results of extensive work with ANGLE's ParsortixTM system at the San Antonio Breast Cancer Symposium (SABCS) detailing how the system can be used to obtain comparable gene expression information from a simple blood test in place of an invasive solid tissue biopsy of a metastatic site.

USC made a direct comparison of extensive gene expression information from the biopsy of the metastatic site with that from a blood test processed with the Parsortix system. Information from the blood test using the Parsortix system "did not show significantly different patterns of expression" compared to the invasive biopsy of the metastatic site. 66 clinically actionable genes in 7 different signalling pathways were measured addressing the key areas that clinicians currently investigate.

ANGLE is working towards an FDA clearance of the Parsortix system in metastatic breast cancer with the required analytical and clinical studies targeted for completion by 30 June 2018. ANGLE is seeking to become the first company ever to receive FDA clearance for a medical device to harvest cancer cells from patient blood for subsequent analysis. The ground-breaking work presented by USC at SABCS demonstrates the importance of being able to harvest and analyse these cells from patient blood.

Julie E. Lang, MD, FACS, Director, USC Breast Cancer Program, Associate Professor of Surgery, Norris Comprehensive Cancer Center, University of Southern California, commented:

"Our study showed that we are able to use a Parsortix liquid biopsy of circulating tumor cells to perform in-depth characterization of potentially clinically actionable treatment opportunities in metastatic breast cancer patients. We demonstrated that circulating tumor cells may serve as a surrogate for biopsies of macrometastases. Successful validation of our approach in future clinical studies could revolutionize clinical management of metastatic breast cancer and advance the promise of personalized cancer therapies, ultimately positively changing the outcome for patients with metastatic disease."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"USC's ground-breaking work with ANGLE's Parsortix system over the last two years has delivered convincing data that a simple blood test may be able to provide all the clinical information traditionally provided by the invasive, expensive solid biopsy. This is great news for ANGLE as it gives a clear guide to the importance of being able to harvest and analyse these cells from patient blood."

USC's poster for SABCS is available online at https://angleplc.com/library/publications/. Key points are summarised below.

The solid biopsies for comparison had to be sourced from numerous different secondary cancer sites including skin, lung, pleural effusion (fluid around the lung), pericardial effusion (fluid around the heart), breast, lymph node, brain, liver, ascites, cerebrospinal fluid (fluid found in the brain and spine) and bone tissue. Gathering this material is an invasive surgical procedure and many women are not well enough to undergo the procedure.

Good RNA expression was obtained from 19/21 of the Parsortix liquid biopsy samples, which is a level of performance that has not been seen previously. The RNA-Seq downstream process used is one of the "subsequent analyses" being evaluated in ANGLE's ANG-002 400 subject clinical study for FDA clearance.

The US National Cancer Institute has estimated that, as at 1 January 2017, more than 150,000 women in the United States were living with metastatic breast cancer and this number is rising. There is a similar level of incidence worldwide. If a regulatory cleared blood test were available all of these women would be candidates for such tests, repeated on a periodic basis during the course of their metastatic disease.

ASCO (American Society of Clinical Oncology) guidelines call for biopsy of a metastatic site to guide the decision making for treatment as it is known that cancers change their status as disease progresses. Access to the secondary cancer site to obtain this tissue biopsy is challenging and requires the patient to undergo an invasive procedure, which causes trauma and delays treatment until they have recovered from the procedure. Furthermore the surgical intervention takes time to arrange, is expensive and diverts resources from care for the patient.

Consequently there is a major market need for a blood test alternative which can provide the same or better information non-invasively. Such a blood test would be non-invasive and could be repeated as often as was needed.

For further information ANGLE:

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

This announcement contains inside information.

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 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 (simple blood test) to be used to provide the cells of interest. Parsortix is the subject of 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 for Europe and FDA clearance is in process for the United States.

ANGLE's analysis technology for proteins and nucleic acids of all types is based on a patented flow through array technology. It provides for highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. A proprietary chemistry allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. These technologies can be combined to provide fully automated, sample to answer results in both centralized laboratory and point of use cartridge formats. It is ideal for measuring gene expression and other markers directly from Parsortix harvests.

ANGLE has established formal collaborations with world-class cancer centres. These Key Opinion Leaders are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. Details are available here http://www.angleplc.com/the-company/collaborators/ 

The analysis of the cells that can be harvested from patient blood with ANGLE's Parsortix system has the potential to help deliver personalised cancer care offering profound improvements in clinical and health economic outcomes in the treatment and diagnosis of various forms of cancer.

The global increase in cancer to a 1 in 3 lifetime incidence is set to drive a multi-billion dollar clinical market. The Parsortix system is designed to be compatible with existing major medtech analytical platforms and to act as a companion diagnostic for major pharma in helping to identify patients that will benefit from a particular drug and then monitoring the drug's effectiveness.

As well as cancer, the Parsortix technology has the potential for deployment with several other important cell types in the future. ANGLE biomarker analysis platforms are adaptable to measure protein and nucleic acid biomarkers across the full spectrum of disease applications.

ANGLE stock trades on the AIM market of the London Stock Exchange under the ticker symbol AGL and in New York on the OTC-QX under the ticker symbol ANPCY. For further information please visit: www.angleplc.com