Angle Regulatory News (AGL)

ANGLE plc ("the Company")

Pharma Services Contract Win

Parsortix DNA Damage Response Assays developed by ANGLE to be used for exploratory objectives in a Phase 1 clinical trial

Trial expected to complete by year end 2024

ANGLE plc (AIM: AGL; OTCQX: ANPCY), a world-leading liquid biopsy company, is delighted to announce that its first bespoke assay development customer, Artios Pharma (Artios), has signed a new contract to utilise two DNA Damage Response assays developed by ANGLE in a Phase 1 clinical trial expected to commence shortly.

Artios is a clinical-stage biotech company pioneering the development of small molecule therapeutics that target the DNA Damage Response (DDR) process in order to treat patients with a broad range of cancers. Artios has an extensive DDR focused pipeline and strategic partnerships with global pharma companies.

Artios selected ANGLE to develop immunofluorescence (IF) assays using its Parsortix system to detect two specific biomarkers expressed on circulating tumour cells (CTCs). The expression of the two biomarkers indicate the amount of DNA damage caused in a cell.

The markers can be observed in tumour tissue, but the availability of tumour tissue biopsy material is limited and cannot be repeated, emphasising the utility of CTCs obtained via liquid biopsy as an alternative means of assessing DNA damage. Artios is utilising longitudinal monitoring of expression of these biomarkers in CTCs harvested using the Parsortix system to assess the pharmacodynamic effects and treatment response to new DDR drugs.

The successful development of these DDR assays (high levels of both sensitivity and specificity were achieved) was technically challenging and a significant achievement. Artios will now utilise the two assays in a Phase 1 clinical trial scheduled to begin shortly and expected to complete around the end of 2024. ANGLE anticipates that these assays could be employed in larger, later stage clinical trials for the same compound and potentially in further trials for additional compounds in the customer's pipeline.

ANGLE can offer this CTC solution to the growing number of drug developers exploring the DDR pathway in drug trials. There are an estimated 105 drugs targeting the DDR pathway in development, with 123,000 patients currently enrolled in active clinical trials (clinicaltrials.gov). In 2020 the global value of DDR therapeutics was US$3.5 billion and is expected to grow to US$ 24.8bn by 2030 with a CAGR of 21.3%.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are delighted to have successfully developed these high-performance assays for Artios, a leader in the fast-growing field of DDR therapeutics. This new contract for clinical trial services again represents significant repeat business from an existing customer and we believe there is potential to expand the relationship further. These new assays also provide an important addition to our pharma services menu where our unique solution has already generated a high level of interest from new potential customers."

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Notes for editors

About Artios www.artios.comArtios is on a mission to kill cancer by exploiting DNA damage repair (DDR) responses that are leveraged by cancer cells to promote their survival. Our specialized DcoDeR platform integrates Artios' leadership capabilities, expertise and experience in DNA damage biology and drug discovery to systematically discover and develop medicines targeting the totality of the DDR. We have built an extensive DDR focused pipeline designed to address areas of high unmet needs across solid tumour indications including our ATR inhibitor, ART0380, and our Polθ inhibitor, ART4215, as a monotherapy and with combination treatments. Together with our world-class strategic partnerships with Merck KGaA and Novartis, and research collaborations with premiere institutions like Cancer Research UK, The Institute of Cancer Research, The Netherlands Cancer Institute, and the Crick Institute we are pioneering validated approaches to DDR drug discovery.

About ANGLE plc www.angleplc.com 

ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected circulating tumor cell (CTC) harvesting technology is known as the Parsortix® system.

ANGLE's Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood.

Intended use

The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays. The end user is responsible for the validation of any downstream assay. The standalone device, as indicated, does not identify, enumerate or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions.

The Parsortix system enables a liquid biopsy (a simple blood test) to be used to provide the circulating metastatic breast cancer cells 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 phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable form (alive). CTCs harvested from the system enable a complete picture of a cancer to be seen; as being an intact cell they allow DNA, RNA and protein analysis as well as cytological and morphological examination and may provide comparable analysis to a tissue biopsy in metastatic breast cancer. 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.

In the United States, the Parsortix® PC1 system has received a Class II Classification from FDA for use with metastatic breast cancer patients. FDA clearance is seen as the global gold standard. ANGLE's Parsortix system is the first ever FDA cleared system for harvesting CTCs for subsequent analysis. ANGLE has applied the IVD CE Mark to the same system for the same intended use in Europe.

ANGLE has also completed three separate 200 subject clinical studies under a programme designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (AUC-ROC) of 95.4% with sensitivity of 90% and specificity of 93%. This excellent clinical result demonstrates the utility of cells harvested by the Parsortix system, which the Company believes is the "best sample" for liquid biopsy analysis as it recovers intact, living cancer cells that are involved in the progression of the disease providing prospective information.

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 79 peer-reviewed publications and numerous publicly available posters from 35 independent cancer centres, available on our website.

ANGLE has established clinical services laboratories in the UK and the United States to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services globally 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.