Angle Regulatory News (AGL)

ANGLE plc ("the Company")

USC PATIENT DATA DEMONSTRATES POTENTIAL OF PARSORTIX FOR METASTATIC BREAST CANCER LIQUID BIOPSY CLINICAL APPLICATION

First head to head comparison of the results of the invasive metastatic biopsy with the results of a Parsortix liquid biopsy

Success shows potential for a simple blood test to direct treatment for metastatic breast cancer

ANGLE plc (AIM:AGL OTCQX:ANPCY), the specialist medtech company, is delighted to announce that the results of the University of Southern California (USC) Norris Comprehensive Cancer Center's ongoing work with ANGLE's Parsortix system have demonstrated the potential for the use of Parsortix as a liquid biopsy for metastatic breast cancer.

USC head to head patient data will be presented today at AACR 2016 (the American Association for Cancer Research Annual Meeting 2016), which demonstrates a statistically significant correlation in metastatic breast cancer between analysis of CTCs (circulating tumor cells) harvested from a simple blood test using Parsortix with similar analysis of tissue obtained from invasive biopsy of a secondary cancer site. The Directors believe that the data demonstrates the potential for the Parsortix liquid biopsy (simple blood test) to replace the invasive biopsy.

Metastasis is responsible for the vast majority of breast cancer related deaths. Initial treatment recommendations for breast cancer are based on primary tumor biology from the initial solid biopsy at patient presentation. However, the recently updated 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.

A liquid biopsy to obtain cancer cells for analysis from a simple blood test has major advantages, including:

In the USC study, the tissue from the invasive biopsy and the CTCs from the Parsortix liquid biopsy harvest were both subjected to Illumina's whole-transcriptome analysis using total RNA sequencing (RNA-Seq). RNA-Seq can accurately measure gene and transcript abundance, and identify known and novel features of the transcriptome. RNA-Seq analysis has been completed on three sample types covering metastatic tissue biopsy, Parsortix harvested CTCs and, as a control, peripheral blood for each of eight patients. This strategy enables measurement of thousands of genes at once in order to generate a comprehensive picture of cellular function.

For every one of these patients, CTCs were successfully harvested and RNA-Seq analysis successfully completed. This analysis demonstrated a statistically significant correlation between the expression signature of 192 genes in the Parsortix harvested CTCs with similar analysis of tissue obtained from an invasive biopsy of a secondary cancer site.

The metastatic biopsy material was sourced from a wide range of metastatic sites including skin, pleural effusion (fluid around the lung), pericardial effusion (fluid around the heart), breast, cerebrospinal fluid (fluid found in the brain and spine) and bone tissue. For all of these different metastatic sites, the Parsortix CTCs provided similar gene expression compared to the metastatic biopsy, allowing for the potential examination of known and novel genes related to breast cancer.

These results suggest that by using Parsortix the same clinically relevant information may be obtained from a patient blood test as from an invasive metastatic biopsy regardless of its location in the patient.

Furthermore a comparison of overall gene expression using Parsortix harvested CTCs and the metastatic biopsy was undertaken for different druggable pathways. 66 potentially clinically actionable genes (i.e. gene targets against which a drug is already available either FDA approved or in clinical trials) were investigated and again there was no statistically significant difference in gene expression between CTCs and invasive tissue biopsy, covering 9 unique pathways. This suggests that the Parsortix system has the potential to be a useful tool for identifying drug targets in metastatic breast cancer and might be utilised to assess the effectiveness of drugs under development in clinical trials.

Breast cancer is the most common cancer in women and the second most common overall. More than 1.7 million cases of breast cancer were recorded in 2012, accounting for around 12 per cent of all new cancer cases and 25 per cent in women. There are 6.3 million women living with breast cancer (Source: World Cancer Research Fund International). It is estimated that 20% to 30% of all breast cancer cases will become metastatic (Source: Metastatic Breast Cancer Network).

Replacement of the metastatic biopsy for breast cancer with a Parsortix blood test would be non-invasive, cheaper and faster, and could be repeated more frequently, thereby providing "real-time" information for therapy selection reflecting disease progression.

ANGLE now intends to work with USC and other leading cancer centres to develop and implement clinical studies to validate the use of the Parsortix system as a clinical application for the routine biopsy of metastatic breast cancer patients. The multi-centre clinical studies need to be specified but would be expected to take at least 18 months to complete.

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

"As a breast cancer surgeon, I am very enthusiastic about the potential of liquid biopsy to gain information to guide the treatment of breast cancer patients based on the specific tumor biology for each patient. Our pilot data shows that potentially the same information can be obtained from a simple blood test using Parsortix as from an invasive tissue biopsy and indeed may be advantageous over invasive tissue biopsies in regards to the diverse sites of metastatic disease, thus providing a compelling rationale for use in clinical practice after further validation."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"These are more highly encouraging results for the use of the Parsortix system this time for an RNA-based clinical application in breast cancer to replace solid metastatic biopsy. This opens the potential of another highly differentiated liquid biopsy application for Parsortix in a key area of medical need, which cannot be addressed by ctDNA, where there is the potential to improve patient care and at the same time reduce healthcare costs."

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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 specialist medtech company commercialising a disruptive platform technology that can capture cells circulating in blood, such as cancer cells, even when they are as rare in number as one cell in one billion blood cells, and harvest the cells for analysis.

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, China 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. Parsortix has a CE Mark for Europe and FDA authorisation is in process for the United States.

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 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