RCS - Angle PLC - NEW STUDY OF PARSORTIX SYSTEM IN NSCLC

AngleAnnouncement

20/07/2022 07:00

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RNS Number : 0317T  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(®) 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/
(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)          +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 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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