Angle Regulatory News (AGL)

ANGLE plc ("the Company")

POSITIVE RESULTS FROM FDA CLINICAL STUDY

Analytical studies ongoing to support FDA submission

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce positive results from its Parsortix FDA clinical study for metastatic breast cancer.

The 400 subject ANG-002 clinical study (the Study) was designed to support a De Novo submission to the United States Food and Drug Administration (FDA) seeking Class II regulatory clearance for ANGLE's ParsortixTM system for the intended use with metastatic breast cancer patients.

The Study has achieved its primary objective to demonstrate the ability of the Parsortix system to capture and harvest cancer cells from the blood of a significant proportion of metastatic breast cancer patients.

The Study has also achieved its exploratory goals by demonstrating that the cells harvested from patient blood using the Parsortix system could be interrogated using different subsequent analysis techniques, including: Wright-Giemsa staining of cytospin preparations for cytopathological evaluation, fluorescent in situ hybridisation (FISH) for evaluation of HER2/neu amplification status, and RT-qPCR for evaluation of cancer related gene expression levels. The harvested cells were also able to be used for the generation of cDNA libraries of sufficient quality for use in RNA-seq evaluation, full bioinformatic analysis is due in June.

ANGLE's ongoing discussions with FDA as part of the De Novo process have recently identified additional analytical study experiments that will be needed to support FDA clearance. It is helpful that these requirements have been identified ahead of FDA submission. The additional studies have minimal cost and are expected to be completed to allow FDA submission in early Q4 CY19 offering the prospect of FDA clearance in early CY20. The timing of FDA regulatory clearance is dependent on the FDA's review and response to our submission.

Further disclosure of data will be reserved to optimise the potential for publication in peer-reviewed journals and to present the data at leading cancer conferences.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are delighted with the positive results from the FDA clinical study. We are working to complete the remaining analytical study work and the full data analysis and interpretation so that an FDA submission can be made as soon as possible.

"We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance1 for a platform that captures and harvests intact circulating tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer. This clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate the Parsortix system and should lead to an acceleration in commercial adoption of the system in both research and clinical settings."

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

1. Despite the estimated addressable market potential for liquid biopsy of greater than US$100 billion per annum across all cancer types in the United States alone (Frost and Sullivan, November 2018), to date, the FDA has cleared only two liquid biopsy applications. The first clearance, for CellSearch, was for CTC enumeration (counting) to assess prognosis in metastatic breast, colorectal or prostate cancers. This contrasts with ANGLE's intended use to capture and harvest CTCs for subsequent analysis. The second clearance, for a liquid biopsy application on the Roche Cobas platform, was for utilising ctDNA (fragments of dead cancer cells) to investigate the presence of an EGFR gene mutation in non-small cell lung cancer. ANGLE is seeking to become the first company ever to obtain FDA clearance for a liquid biopsy platform that will capture and harvest CTCs for subsequent analysis, in the first instance for metastatic breast cancer patients.

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 (via a simple blood draw) 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. The Parsortix system enables the capture and harvest of live cells and cell clusters that can be harvested and cultured. The Parsortix technology is the subject of 21 granted patents in Europe, the United States, Canada, India, China, Japan and Australia 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 a 200 subject clinical verification study.

ANGLE's technology for the multiplex evaluation of nucleic acids and proteins 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 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 20 peer-reviewed publications and numerous publicly available posters, available on our website.