TIDMAGL
Angle PLC
12 September 2022
For immediate release 12 September 2022
ANGLE plc ("the Company")
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
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(R) 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/ .
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Andrew Holder, Head of Investor Relations
Berenberg (NOMAD and Joint Broker)
Toby Flaux, Ciaran Walsh, Milo Bonser +44 (0) 20 3207 7800
Jefferies (Joint Broker)
Max Jones, Thomas Bective +44 (0) 20 7029 8000
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
For Frequently Used Terms, please see the Company's website on
https://angleplc.com/investor-relations/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 known as the Parsortix(R) system and a downstream
analysis system for cost effective, highly multiplexed analysis of
nucleic acids and proteins.
ANGLE's Parsortix(R) 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(R) PC1 system is an in vitro diagnostic device
intended to enrich circulating tumor cells (CTCs) from peripheral
blood collected in K(2) EDTA 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(R) 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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