PARTNERSHIP ESTABLISHED WITH A MAJOR UNITED STATES UROLOGY GROUP TO CONDUCT CLINICAL STUDIES IN PROSTATE CANCER AND AS A POTENTIAL ROUTE TO MARKET

MidLantic Urology to evaluate the Parsortix system in prostate cancer clinical studies and enable potential sales to Solaris Health extensive patient base

Major unmet medical need for a pre-screening tool ahead of invasive prostate tissue biopsy as an aid to assessing prostate cancer presence and aggressiveness to guide treatment choices

GUILDFORD, UK / ACCESSWIRE / May 30, 2022 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce it has signed a master clinical study agreement with Solaris Health Holdings, LLC (Solaris) and joinder agreements with MidLantic Urology LLC, to collaborate and conduct clinical studies in prostate cancer and as a potential route to market in the United States.

MidLantic Urology, an affiliate of Solaris, is one of the largest providers of specialist urology services in the United States with more than 70 physicians operating from 47 dedicated urology centres across the state of Pennsylvania. The Solaris Health network encompasses more than 500 clinical urology providers across 179 locations and nine States with more than 729,000 unique patients annually.

Together with MidLantic Urology, ANGLE will initiate clinical studies aimed at investigating the use of the Parsortix^® system for the detection of prostate cancer and prediction of its severity in patients who present with an elevated prostate specific antigen (PSA) level and/or abnormal digital rectal exam.

The design of the first study to be conducted with MidLantic Urology, expected to be initiated in Q3 2022, has been informed by earlier pilot studies independently conducted at the Barts Cancer Institute (Queen Mary University London) which used the Parsortix system to harvest circulating tumour cells (CTCs). This study will initially enrol 100 men scheduled to undergo a prostate tissue biopsy at a minimum of three study sites over an anticipated period of up to nine months. Blood samples collected by MidLantic Urology will be shipped to ANGLE's United States clinical laboratory for processing by the Parsortix system to harvest and analyse CTCs and associated immune cells. The Parsortix harvests will be evaluated by both imaging and molecular analysis to assess the potential to predict the presence of clinically significant prostate cancer prior to tissue biopsy and to assess potential correlation with established disease severity scores (e.g. the Gleason score) in those patients found to have prostate cancer.

ANGLE expects headline results from the first study of 100 men in 2023. Compelling data could form the basis of a laboratory developed test which ANGLE would offer from its clinical laboratories in the United States and the UK. Solaris could be ANGLE's first route to market for this test, offering the established test to their extensive patient base. Successful results could also allow the design of a larger validation study to support an eventual submission to FDA and other regulatory bodies for this application.

Prostate cancer is the leading cause of cancer in men and accounts for 13% of all new cancer cases in the United States. Under the national screening programme, 11 million men will undergo a PSA test in the US each year. Of these, some 1.2 million will have an abnormal result, leading to further investigations. The current standard of care, transrectal or transperitoneal prostate tissue biopsy, is an invasive procedure associated with significant clinical complications and cost. Following the procedure, 32% of patients are reported to experience moderate side effects, with 1.4% of patients experiencing major complications. This includes post-biopsy sepsis in 2-5% of cases with up to 25% requiring admission to ICU at an estimated cost of US$19,000 per patient. Prostate tissue biopsies are negative in 75% of patients and therefore place patients at unnecessary risk but may also miss the cancer in 30-40% of cases, requiring patients to undergo repeat tissue biopsy. At least 60% of prostate cancers diagnosed are indolent and unlikely to cause harm during a patient's lifetime. Nonetheless many men will undergo radical prostatectomy which is associated with significant post-procedure complications including urinary incontinence and erectile dysfunction. Liquid biopsy offers the potential for a much safer, cost-effective diagnosis, active surveillance where appropriate and, following diagnosis, the ability to offer longitudinal monitoring and up to date targeted treatment selection.

Dr Jose Moreno, Principal Investigator, MidLantic Urology, commented:

"Even though PSA is a valuable marker of response to prostate cancer treatment, its role in screening is modest at best and can lead to both overdiagnosis of clinically indolent prostate cancer and underdiagnosis of clinically significant prostate cancer which can result in increased rates of local failure and metastatic disease.

ANGLE's Parsortix platform has the potential to enable molecular characterisation of the cancer using a blood test in patients undergoing both traditional ultrasound biopsies and MRI fusion biopsies. The preliminary data suggest that we may be able to create an assay for the detection of clinically significant prostate cancer that has high specificity and sensitivity. Moreover, the assay can be customized to operate in a wide spectrum of prostate cancer disease states, including pre-prostate biopsy, after a negative biopsy, active surveillance, after local failure, and in early and late metastatic disease states. If our results are validated, our MidLantic Urology patients and Solaris Health affiliates may be the first to benefit from these developments."

ANGLE Founder and Chief Executive, Andrew Newland, added:

"We are delighted that Solaris and MidLantic Urology have agreed to work with ANGLE on clinical studies in prostate cancer, which build on prior work done by Barts Cancer Institute and demonstrates the power of our leveraged research approach. Successful development of this simple blood test could prevent men from being subjected to unnecessary tissue biopsies when they either do not have prostate cancer (despite the elevated level of PSA) or their cancer is indolent and unlikely to impact either their life expectancy or quality of life.

The funding for this study, which addresses a major unmet medical need, was a key element of our capital raise last year and could open up a significant market opportunity for ANGLE. Initiation of the study, expected in the near future, delivers on another business milestone as we build out our commercial plans for the Parsortix system."

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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 known as the Parsortix^® system and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.

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 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 60 peer-reviewed publications and numerous publicly available posters from 31 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.

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SOURCE: ANGLE plc