TIDMAGL
Angle PLC
20 July 2022
For immediate release 20 July 2022
ANGLE plc ("the Company")
NEW STUDY HIGHLIGHTS USE OF PARSORTIX SYSTEM TO ENABLE CANCER
CELL DNA ANALYSIS IN NON-SMALL CELL LUNG CANCER
Published study results found DNA methylation of genes from
liquid biopsies provide insight into prognosis for early-stage
non-small cell lung cancer patients
DNA methylation analysis has potential to be utilised for cancer
diagnosis and epigenetic cancer research
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that the world-class research team
led by Prof. Evi Lianidou at the National and Kapodistrian
University of Athens, Greece, has recently published results of a
study undertaken in early-stage non-small cell lung cancer (NSCLC),
which demonstrates the benefit of analysing epigenetic alterations
in circulating tumour cells (CTCs) to assess patient prognosis.
DNA methylation is a hallmark of cancer. The aim of the study
was to evaluate the prognostic value of DNA methylation in five
specific tumour suppressor genes commonly associated with tumour
growth and metastasis in liquid biopsy samples. The researchers
used the Parsortix(R) system to isolate CTCs from 42 early-stage
NSCLC patients for DNA methylation analysis.
After harvesting from the Parsortix system, captured CTCs were
lysed and genomic DNA was extracted. Once DNA integrity had been
evaluated, the DNA was amplified and methylation detected by
real-time methylation specific PCR assays for the targeted genes.
The isolation of DNA from intact cancer cells using the Parsortix
system is advantageous as it provides a prospective outlook,
allowing real-time monitoring of tumour evolution as opposed to
ctDNA which is typically derived from dead or dying cells and thus
may fail to capture the most clinically relevant and up to date
tumour characteristics.
This research identified that DNA methylation of at least one of
the five selected genes in CTC or ctDNA samples was associated with
a worse prognosis in early-stage NSCLC. The study highlights the
potential of DNA methylation analysis from a CTC based liquid
biopsy to provide prognostic information for patients with
early-stage NSCLC.
In the United States, lung cancer is the second most common
cause of cancer and the leading cause of cancer related mortality,
responsible for 22% of all cancer related deaths. In 2022, the
National Cancer Institute estimates that there will be a total of
236,740 new cases and 130,180 deaths with NSCLC accounting for 84%
of all lung cancer cases. Whilst the overall 5-year survival rate
for NSCLC is 23%, 55% of patients are diagnosed with metastatic
(stage IV) disease for which the 5-year relative survival rate is
just 7%.
Professor Evi Lianidou, Head of the Molecular Diagnostics
Laboratory focused on Liquid Biopsy (ACTC lab) at the Department of
Chemistry, National and Kapodistrian University of Athens,
commented:
"This research indicates that the combination of DNA methylation
analysis of tumour suppressor genes in CTCs and matched
plasma-ctDNA provides significant prognostic information in
patients with early-stage non-small cell lung cancer. Additional
studies are required to validate our findings in a larger cohort of
patients."
ANGLE Founder and Chief Executive, Andrew Newland, added:
"We are pleased to report on the use of the Parsortix system for
the isolation of CTCs in early-stage NSCLC, showing potential to
enable genetic analysis that provides informative prognostic
information. This showcases the potential of liquid biopsy, using
the Parsortix system, as a promising tool for the assessment of
early-stage disease, which is a key priority for healthcare systems
world-wide."
The research has been published as a peer-reviewed publication
in the Journal Clinical Epigenetics and is 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
64 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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