ANGLE plc ("the Company")

PARSORTIX SYSTEM SHOWS POTENTIAL FOR PROVIDING RAPID INFORMATION ON PATIENT RESPONSE TO THERAPIES TARGETING METASTASIS

Existing chemotherapies, such as vinorelbine, may selectively target and reduce the metastatic potential of CTCs

Detecting a reduction of microtentacles, that enable the spread of cancer, on live CTCs indicates a positive response to therapy

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that the University of Maryland Marlene and Stewart Greenebaum NCI Comprehensive Cancer Institute, Baltimore, Maryland, USA, has published results of work undertaken in preclinical models of triple-negative breast cancer (TNBC), showing that isolation of live circulating tumour cells (CTCs) from a simple blood draw, using the Parsortix^® system, can provide rapid information on patient response to existing chemotherapy treatments that can target metastasis more effectively than tumour growth.

The research team has previously demonstrated that breast cancer cells circulating in the blood form unique microtentacles that enable the spread and formation of tumours at secondary sites. Microtentacles are supported by microtubules, which are the target for many FDA-approved chemotherapy drugs, such as vinorelbine used in this study.

Using preclinical TNBC models, the researchers showed that vinorelbine treatment increased the time taken for the cancer to spread from 8 to 30 weeks.  However, a 24-hour vinorelbine treatment had little effect on the primary tumour development and survival, indicating selective targeting of the metastatic potential of CTCs through microtubule disruption. The results of this study indicate that CTCs demonstrate specific features which can be leveraged to reveal the anti-metastatic capabilities of vinorelbine and potentially other existing FDA-approved therapies.

In the US, breast cancer is the most frequently diagnosed cancer in women with 287,000 new cases expected in 2022, accounting for 31% of all new cancer cases. The American Cancer Society estimates that TNBC accounts for about 10-15% of all breast cancers. TNBC differs from other types of invasive breast cancer in that it grows and spreads faster, has limited treatment choices, and a worse prognosis. TNBC patients are recommended for chemotherapy treatments, due to lack of targeted therapies, yet some pre-clinical studies have shown that neoadjuvant chemotherapy can increase the risk of metastasis. There is an urgent need to improve treatment options for patients with early stage TNBC that can reduce the metastatic risk.

Prof Stuart Martin, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, commented:

"Cancer drugs that broadly disrupt microtubules have long proven effective at reducing tumor growth and improving patient survival, but also have significant toxicities that limit dosing. The focused treatment reported here reduced microtentacles and metastasis at well below the maximum-tolerated dose. If it is possible to use a focused treatment to reduce CTC metastasis, the most likely opportunity for therapies to reduce CTC metastasis would be combination therapy at the time of primary tumor treatment, helping to ensure that CTCs shed by that primary tumor treatment have reduced metastatic potential".

ANGLE Founder and Chief Executive, Andrew Newland, added:

"We are pleased to report on the use of the Parsortix system for the isolation of live CTCs in pre-clinical TNBC models, uncovering the potential to provide rapid information on how a patient is responding to a therapy. ANGLE's ability to provide actionable insight could help patients with limited treatment options and could help to identify already approved drugs that could target highly metastatic and hard-to-treat cancers, such as TNBC."

The research has been published as a peer-reviewed publication in the journal Breast Cancer Research and is available online at https://angleplc.com/library/publications/.

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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 the cells of interest to the user in a format suitable for multiple types of downstream analyses.  The system is based on 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 an intact cell they allow DNA, RNA and protein analysis and may provide comparable analysis to a tissue biopsy. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status of a patient's tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor response to drugs outside the patient.

The Parsortix technology is the subject of 26 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, in the United States, a De Novo Submission has been made to FDA for the Parsortix^® PC1 system seeking FDA clearance with Class II Classification for use with metastatic breast cancer patients. FDA clearance is seen as the global standard. ANGLE is seeking to be the first ever FDA cleared system for harvesting CTCs for subsequent analysis.

ANGLE has also completed 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 (AUC-ROC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimisation and a 200 patient clinical verification study has now completed enrolment.

ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEAD^TM 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 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 (AUC-ROC) 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 58 peer-reviewed publications and numerous publicly available posters, available on our website.

ANGLE has established clinical services laboratories in the UK and USA to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services to pharmaceutical and biotech customers for use of Parsortix in cancer drug trials and, once the laboratories are accredited and tests validated, will provide Laboratory Developed Tests (LDTs) for patient management.