Angle PLC Announces Business Update

• Progress across multiple fronts
• In-house capability developed to determine CTC PDL1 status for immunotherapy trials
• COVID-19 highlights crucial need for liquid biopsy for cancer patients

GUILDFORD, SURREY / ACCESSWIRE / April 28, 2020 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to provide an update on the Company’s progress since the COVID-19 lock down started.

As announced on 31 March 2020, ANGLE’s operations in the UK, Canada and USA have been impacted by the COVID-19 pandemic and the resulting Government directives, notably in relation to completion of the remaining analytical samples required for the Company’s FDA submission and patient enrolment for the Company’s ovarian cancer clinical verification study.

Following a period of unanticipated disruption and delay caused by COVID-19, a key focus during lock down is on finalising the significant amount of written documentation and analysis for the FDA submission, so that this can be rapidly submitted once the remaining analytical samples are available and analysed. This is progressing well and it is expected that submission can be made promptly once restrictions ease so that we can secure the remaining healthy volunteer blood samples needed to complete the analytical study work.

The Company has adopted a proactive approach to the lock down advancing on multiple fronts and developing some new initiatives.

R&D, product development and engineering work

The Company’s Guildford UK laboratories are now operating with a skeleton crew, double shift operation with enhanced social distancing and other precautions in place to enable the progression of experimental and engineering work that does not require access to donor blood. This work is supporting key Parsortix^® system R&D, product development and engineering activities.

Ovarian cancer test

The Company’s Toronto Canada laboratories are open for technical personnel who cannot work from home, also with double shift operation and enhanced social distancing and other precautions in place. This is enabling HyCEAD^® Ziplex^™ analytical and assay verification work for the ovarian cancer test to progress.

The University of Rochester Medical Center Wilmot Cancer Institute, New York has temporarily ceased patient enrolment. In the absence of the current clinical verification study samples, the decision has been taken to analyse the second retained samples from the previous ovarian cancer clinical study. This was a duplicate blood sample from every patient that was processed on Parsortix and then stored as a frozen lysate. Analysis of these samples will use the further optimised HyCEAD Ziplex cancer gene panel planned for the current study.

This may allow the Company to generate clinical results in the middle of the year to assist in the negotiations with clinical laboratory partners that might wish to implement the test, ahead of the data from the current clinical verification study being available.

PDL1 assessment capability

As announced on 17 April 2020, the Molecular Diagnostics Laboratory focused on Liquid Biopsy (ACTC lab) at the Department of Chemistry, University of Athens published multi-year work in Nature Scientific Reports, demonstrating the use of the Parsortix system for enabling the molecular analysis of circulating tumor cells (CTCs) in head and neck cancer (HNSCC), including the investigation of PDL1 (programmed death-ligand 1) expression, a key target for leading immunotherapy drugs. This followed multi-year work by University Medical Centre Hamburg-Eppendorf (UKE) published in Cancers as announced on 21 June 2019, demonstrating use of the Parsortix system for PDL1 molecular analysis in non small cell lung cancer (NSCLC) patients.

ANGLE R&D staff have been working extensively on an immunofluorescence (IF) imaging assay for determination of PDL1 expression levels in CTCs harvested by the Parsortix system. Since lock down, this work has been completed and we now have a method for assessing the presence and number of PDL1 positive and PDL1 negative CTCs in patient blood samples. This approach examines actual cells (cytological analysis) as opposed to molecular analysis approaches, which work with cell lysates (nucleic contents of cells that have been broken open, analysed as a mixture). Currently the PDL1 expression assay is Research Use Only, we are examining options for clinical development.

The newly developed inhouse cell-based approach will enable use of the Parsortix system to assess PDL1 status using two complementary techniques, molecular analysis and cell imaging (IF). We believe this is a powerful combination, which, together with the key advantages of the Parsortix system to capture both epithelial and mesenchymal CTCs (traditional antibody-based systems fail to capture the clinically relevant mesenchymal CTCs) and to capture CTC clusters, may provide significant benefits to the pharma services market.

Pharma services cancer drug trials

There are numerous immunotherapy cancer drug trials in progress or planned where assessment of PDL1 status on CTCs from patient blood samples may have a major bearing on whether the trial is successful. The new trials being planned are targets for adoption of the Parsortix system and ANGLE is developing a service capability to be able to process samples on a commercial basis as part of these trials.

ANGLE has established a proactive business development process, taking advantage of the increased accessibility of key executives during lock down, to establish dialogue with prospective customers and collaborators for the deployment of PDL1 analysis capabilities in pharma services cancer drug trials.

The investigation of PDL1 is a key target for leading immunotherapy drugs such as Pembrolizumab (also known as Keytruda from Merck), Nivolumab (also known as Opdivo from BMS), Durvalumab (also known as Imfinzi from AstraZeneca) and Atezolizumab (also known as Tecentriq from Roche). As of September 2019, there were 2,975 active drug trials targeting PDL1 (and the receptor to which it binds, PD1), planning to recruit over 500,000 patients. Thus, there is a need for an effective biomarker strategy to identify responding patients (Source: https://www.nature.com/articles/d41573-019-00182-w), which we believe the Parsortix system is now capable of meeting.

Other financial matters

In addition to these proactive efforts, ANGLE has taken steps to manage resources and has furloughed a number of staff who are unable to work remotely in the current situation in order to protect their jobs whilst temporarily reducing the Company’s operating costs. We have also received the R&D tax credit due from HMRC of £1.9 million referred to in our 31 March 2020 announcement. As previously reported, ANGLE has sufficient cash for planned operations until mid-2021.

Impact of COVID-19 on cancer patients

During lock down, ‘non-essential’ screening, surgical and other procedures in cancer treatment have been postponed, delayed or cancelled by clinical institutions across the world. This extends to procedures such as tissue biopsies both of primary cancer sites for diagnosis and secondary cancer sites for treatment selection. The delay of these procedures may have significant adverse impacts for patients. This highlights the need for the regulatory approval of a CTC based liquid biopsy alternative to such invasive tissue biopsy procedures. Harvested cancer cells from a simple blood test that could be used to progress a patient’s diagnosis and treatment while reducing the time to answer delays associated with the processing and pathological evaluation of tissue biopsies would be extremely valuable.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

“Our business continuity plans are proving robust and I am extremely pleased with the dedication our staff have shown in adapting to working under the current restrictions. The developments we have made in assessing PDL1 status present an opportunity for ANGLE to address the pharma services market.

During the lock down period, ‘non-essential’ screening, surgical and other procedures in cancer treatment have been postponed, delayed or cancelled globally. This situation highlights the need for the regulatory approval of a CTC liquid biopsy alternative to invasive tissue biopsy procedures as delay in these procedures can have serious adverse impacts for cancer patients.

ANGLE is even more determined to complete the many years of work already undertaken to obtain the first ever FDA regulatory clearance for a simple blood test to harvest cancer cells for analysis. We will be ready to promptly complete our FDA submission once we are permitted to secure the remaining healthy volunteer blood samples needed.”

For further information:

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 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 cells of interest to users in a format suitable for multiple types of downstream analyses. The system uses 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 a complete cell, they allow DNA, RNA and protein analysis, and the live cells harvested can also 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 Parsortix system has a CE Mark in Europe for the indicated use and submission to FDA for clearance is in process for the United States using results from two separate clinical studies of over 250 metastatic breast cancer patients and associated analytical studies. 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 200 patient clinical verification study.

ANGLE’s technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEAD^TM 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 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 (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 31 peer-reviewed publications and numerous publicly available posters, available on our website.

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SOURCE: ANGLE plc

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