RCS - Angle PLC - Novel insight into metastasis in NSCLC patients

AngleAnnouncement

28/07/2022 07:16

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RNS Number : 9947T  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(®) 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)          +44 (0) 20 3207 7800

 Toby Flaux, Ciaran Walsh, Milo Bonser

 Jefferies (Joint Broker)                    +44 (0) 20 7029 8000

 Max Jones, Thomas Bective

 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/
(https://angleplc.com/investor-relations/glossary/)

 

Notes for editors

 

About ANGLE plc www.angleplc.com (http://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
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(®) 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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