NOVEL ASSAY DEVELOPED USING THE PARSORTIX SYSTEM ACCURATELY PREDICTS MALIGNANCY IN PELVIC MASS

Publication of results from ANGLE's pelvic mass pilot study in collaboration with Wilmot Cancer Institute in a high impact journal

Study informed the development of ANGLE's pelvic mass triage test for detection of ovarian cancer requiring surgical intervention

GUILDFORD, SURREY / ACCESSWIRE / September 12, 2022 / ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce the publication of results from a clinical study undertaken in partnership with the Wilmot Cancer Institute, University of Rochester, NY, US. The Parsortix^® system was utilised for cancer detection in 183 women with a pelvic mass who had a range of benign and malignant conditions. The results have been published in the respected, high impact, journal Obstetrics & Gynecology ("The Green Journal").

The population of cells captured from peripheral blood by the Parsortix system were subjected to multiplexed gene expression analysis, and these results were combined with serum protein biomarkers to form a predictive algorithm, referred to as the Malignancy Assessment using Gene Identification in Captured Cells ("MAGIC") algorithm. The MAGIC algorithm successfully and accurately detected malignancy in women with a pelvic mass more effectively than serum biomarkers alone. The MAGIC algorithm's unique grouping of 8 genes and 4 serum biomarkers (ROC-AUC 95.1%, 95% CI = 92.0 - 98.2%) significantly outperformed all individual genes (ROC-AUCs = 50.2 to 65.2%; all p<0.001), the serum biomarker only algorithm (ROC-AUC = 89.6%, 95% CI = 84.3 - 95.0%), and the gene only algorithm (ROC-AUC = 88.0, 95% CI = 82.9 - 93.0%, p=0.005) for the discrimination of benign tumours from all cancers. Importantly, MAGIC was able to accurately identify malignancy for both early stage (ROC-AUC: 89.5%, 95% CI = 81.3 - 97.8%) and late-stage (ROC-AUC: 98.9%, 95% CI = 96.7 - 100%) epithelial ovarian cancer. Furthermore, the algorithm not only detected epithelial ovarian cancer, but also detected non-ovarian primary cancers and metastatic cancers.

This research highlights the potential of combining the multiplexed gene analysis of captured cells with serum biomarkers from a simple blood test for rapid and accurate pelvic mass triage. This may help to identify the presence of gynaecological cancers at an earlier stage whilst accurately identifying benign conditions that could be managed locally rather than by a specialist.

This successful study was used to inform a clinical verification study which is currently ongoing and from which headline results are expected shortly. Assuming similar results, ANGLE intends to establish this test (referred to as the Landscape+^TM Ovarian assay) as a laboratory developed test in its own clinical laboratories. The test has the potential to significantly improve patient outcomes whilst at the same time reduce overall healthcare costs.

Approximately 5-10% of women will present with a pelvic mass during their lifetime. For these women, accurate and early diagnosis of malignancy is critical. Around 20,000 women are diagnosed with ovarian cancer in the US each year. Sadly, almost 60% of cases are diagnosed when the cancer has metastasised, resulting in a 5-year survival rate of just 31%. Current diagnosis relies on imaging and elevated levels of serum biomarker CA-125, which has poor specificity. Where malignancy is suspected, patients usually undergo surgical resection. However, there is a need for more accurate and timelier triage of patients with a pelvic mass to enable early detection of malignancy so that these patients can be referred to high volume physicians and institutions. It has been shown that surgical staging and debulking by gynaecological oncologists at these high-volume institutions improves survival for ovarian cancer patients.

Dr Richard Moore, Director of the division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester commented:

"As a leading translational research team with a focus on gynecologic oncology biomarkers, we are excited to present the results of this important study. Ovarian cancer is difficult to detect in women with an ovarian cyst or a pelvic mass and identifying patients at high risk is critical. Our team, in association with ANGLE plc, created the MAGIC algorithm employing the Parsortix system as a key tool in assisting in the detection of ovarian cancer in patients with a pelvic mass, an area of significant unmet need. I also see this technology as an important tool for prognostic indicators and even diagnosis as further research is developed."

Professor Kyu Kwang Kim, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester added:

"This hybrid technology explores the versatility of CTC evaluation in combination with serum biomarkers to improve the detection of cancer. The MAGIC algorithm is an exciting advance towards more effective pelvic mass triage."

ANGLE Founder and Chief Executive, Andrew Newland, added:

"Currently gene expression in CTCs is an emerging field not yet incorporated into existing clinical risk-stratification models for ovarian cancer. This prospective clinical trial employing novel technology introduces the combination of CTC and serum biomarker analysis and is therefore an important milestone towards improving pelvic mass triage. We now look forward to receiving the headline results from an ongoing clinical verification study in this setting, and we anticipate that the Landscape+ Ovarian assay will be ANGLE's first laboratory developed test to be offered from our own clinical laboratories."

The research has been published as a peer-reviewed publication in the Journal Obstetrics & Gynecology and will be available online at https://angleplc.com/library/publications/.

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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 68 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