Angle Regulatory News (AGL)

LEADING CANCER CENTRE DEMONSTRATES USE OF PARSORTIX AS A LIQUID BIOPSY TO INVESTIGATE KEY IMMUNOTHERAPY TARGET IN LUNG CANCER

Potential for use of Parsortix as treatment selection biomarker in assessing patient response to cancer immunotherapy drugs with revenues forecast to exceed US$ 20 billion this year

Lung cancer is a key target for liquid biopsy with up to 24% of patients experiencing complications from traditional tissue biopsy and many biopsies failing to yield tissue that can be analysed

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that leading European cancer centre, University Medical Centre Hamburg-Eppendorf (UKE) has published results of work demonstrating that ANGLE's ParsortixTM system can be used as a liquid biopsy to investigate programmed death-ligand 1 (PD-L1) status in non small cell lung cancer (NSCLC) patients.

Expression of the protein PD-L1 in cancer cells is of particular importance as PD-L1, and PD-1 the protein to which it binds, are the key targets for leading immunotherapy drugs, with revenues forecast to exceed US$ 20 billion in 2019. Immunotherapy drugs can be very effective for some patients. However, typically only 20-30% of patients will respond and it is crucial to be able to accurately identify which patients, both to reduce the patient's exposure to unnecessary drug toxicity and to reduce unnecessary healthcare expenditure, given such treatment can cost around US$150,000 per patient each year and only a minority of patients benefit.

The research by UKE undertaken using Parsortix over a three year period and published in Cancers, a renowned peer-reviewed medical journal, shows that in a head-to-head comparison of 97 lung cancer patients, Parsortix was able to detect circulating tumor cells (CTCs) in nearly twice as many patients as the leading competing system. Furthermore, the research showed that the PD-L1 expression in a tissue biopsy (the current standard of care, which is invasive and expensive) does not always reflect the heterogeneity of PD-L1 expression in the cancer of Stage IV NSCLC patients with multiple tumor sites and a Parsortix CTC liquid biopsy could therefore provide more comprehensive information.

A longitudinal investigation using Parsortix in NSCLC patients (n=11) being treated with immunotherapy drugs Pembrolizumab (Keytruda - Merck & Co), Nivolumab (Opdivo - Bristol-Myers Squibb) or Atezolizumab (Tecentriq - Roche Genentech) over multiple time points, investigated the changes in PD-L1 positive and negative circulating tumor cells (CTCs). In all the NSCLC patients that developed resistance to these immunotherapies (n=5), i.e. patients stopped responding to the drug or did not respond to the drug, an increase in PD-L1+ CTCs was identified compared to earlier time points.

UKE's success in using Parsortix for PD-L1 analysis in NSCLC is consistent with work previously published demonstrating the use of Parsortix for PD-L1 analysis in head and neck squamous cell carcinoma (HNSCC) and we would anticipate that Parsortix could be used for PD-L1 analysis in multiple other cancer types. Keytruda, for example, is a broad spectrum anti-cancer drug and has already been approved for 15 cancers and 10 tumor types.

Tissue biopsy in the lung, both for lung cancer and as a common metastatic site, is challenging and carries significant risk with up to 24% of patients experiencing serious complications and up to 1% resulting in death. Further the tissue biopsy is expensive, impractical for repeat testing and a significant proportion of biopsies fail to provide sufficient quality or quantity of tissue for accurate analysis. The Parsortix CTC liquid biopsy has the potential to address these limitations through a simple blood test. The ctDNA liquid biopsy approach (fragments of DNA from dead cancer cells) used by a number of large scale laboratories cannot analyse PD-L1 as this is a protein expression on the cancer cells.

Lung cancer has the highest incidence and mortality rate of all cancers (World Cancer Factsheet 2018: 2.1 million new cancer cases and 1.8 million deaths per annum).

ANGLE believes there is an opportunity to build on the work undertaken to provide services to pharmaceutical drug trials in determining likely patient responders and as a companion diagnostic to assess which patients are likely to respond to particular immunotherapies.

ANGLE's Founder and Chief Executive, Andrew Newland, commented:

"The ability to identify which patients will respond to PD-L1/PD-1 immunotherapies and to assess response to these drugs during treatment, is a major unmet medical need. The Parsortix system addresses key shortcomings in alternative approaches offering the potential for routine liquid biopsies through a simple blood test."

A copy of the Cancers publication is available on ANGLE's website here

https://angleplc.com/library/publications/.

For further information ANGLE:

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 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 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 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 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 21 peer-reviewed publications and numerous publicly available posters, available on our website.