TIDMAGL
Angle PLC
28 July 2022
For immediate release 28 July 2022
ANGLE plc ("the Company")
CTCS HARVESTED USING THE PARSORTIX SYSTEM PROVIDE NOVEL INSIGHT
INTO METASTASIS IN EARLY-STAGE NON-SMALL CELL LUNG CANCER
PATIENTS
Metabolism-Related Genes are overexpressed in the CTCs of
early-stage NSCLC patients harvested using Parsortix and are
associated with mesenchymal markers
Identifying the overexpression of metabolic function markers in
CTCs may provide new prospective biomarkers to aid diagnosis
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce details of a new separate study
from the world-class research team led by Prof. Evi Lianidou at the
National and Kapodistrian University of Athens, Greece. The study
used the Parsortix(R) system to harvest CTCs from whole blood
samples from 46 early-stage non-small cell lung cancer (NSCLC)
patients, to analyse the expression of Metabolism-Related Genes
(MRGs). Use of the biomarker-independent Parsortix system also
allowed the researchers to investigate the association of MRG
expression with epithelial and epithelial to mesenchymal transition
(EMT) markers.
Using the Parsortix system, followed by quantitative PCR
(RT-qPCR) analysis, the authors examined the molecular expression
of three MRGs in CTCs from early-stage NSCLC patients prior to
surgery (baseline), one month following surgery and at relapse.
Overexpression of at least one of the three MRGs was detected in
47.8% patients prior to surgery. Analysis of CTCs in patients one
month after surgery showed a reduction in the expression of two of
the MRGs compared to baseline levels. Subsequently, expression of
two of the three MRGs analysed increased in CTCs at relapse.
The researchers also demonstrated that overexpression of two
MRGs were associated with the overexpression of mesenchymal markers
in a subpopulation of CTCs from these early-stage NSCLC patients.
The EMT of CTCs is a hallmark of NSCLC and has limited the ability
to accurately identify and enumerate CTCs using EpCAM dependent
approaches. The use of the biomarker-independent Parsortix system
in this study, which instead relies on cell size and deformability
to isolate CTCs, allowed the researchers to capture and analyse
epithelial, mesenchymal and transitioning CTCs. EpCAM-dependent
systems would have been unable to detect mesenchymal CTCs and
consequently would have missed the crucial association between the
MRGs analysed and mesenchymal markers.
This new research supports the importance of MRGs in metastasis
and shows that MRG overexpression can be assessed in CTCs isolated
from early-stage NSCLC patients. The overexpression of the MRGs
analysed in this study points to their utility as potential
biomarkers in NSCLC. Globally, lung cancer remains the leading
cause of cancer death with NSCLC accounting for over 80% of all
lung cancers. Whilst the overall 5-year survival rate for lung
cancer is 23%, 55% of patients are diagnosed with metastatic (stage
IV) disease for which the 5-year relative survival rate is just 7%.
Thus, there is an urgent need for early diagnosis and effective
targeted treatment options to improve both the quality and
longevity of those patients whose lives are affected by this
disease.
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:
"MRG overexpression was observed at a high frequency in the CTCs
of early-stage NSCLC patients, supporting its role in metastatic
processes. The glycolytic and mesenchymal subpopulation of CTCs was
significantly predominant compared to CTCs that were glycolytic and
not mesenchymal-like. Our data indicate that MRGs merit further
evaluation through large and well-defined cohort studies."
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"ANGLE is pleased to announce further world-class research
published by Prof. Lianidou and her team, providing novel insight
into the role of MRGs as biomarkers for disease remission or
relapse in NSCLC.
"The high proportion of mesenchymal CTCs observed in patients
who had relapsed demonstrates the importance of isolating this
subset of CTCs which is enabled by the Parsortix system. Not only
could MRGs be utilised as a biomarker for cancer relapse and
disease progression but could also have potential as a target for
drug discovery."
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
65 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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