TIDMAGL
Angle PLC
27 September 2021
For immediate release 27 September 2021
ANGLE plc ("the Company")
Parsortix system demonstrates ability to isolate CTCs for
downstream gene analysis revealing multiple prognostic
biomarkers
Leading European study centre presents results of three studies
in ovarian and lung cancer at 5(th) ACTC Conference
Novel CTC biomarkers found to predict progression free survival
and treatment response for longitudinal patient monitoring in
ovarian cancer
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that the Molecular Oncology Group
at the Medical University of Vienna, presented results of three
studies at the 5(th) Advances in Circulating Tumour Cells (ACTC)
conference, held 22-25 September in Kalamata, Greece.
The studies in ovarian cancer, small cell lung cancer (SCLC) and
non-small cell lung cancer (NSCLC) patients, all utilised ANGLE's
biomarker-independent Parsortix(R) system to isolate circulating
tumour cells (CTCs) from a simple blood draw.
The largest study, a Phase II drug trial including 133 ovarian
cancer patients, explored longitudinal gene expression of CTCs
isolated using the Parsortix system in platinum-resistant patients
enrolled on the GANNET53 trial over a five year period with an
average four time points for each patient. Gene expression analysis
of genes expressed on CTCs isolated from successive blood draws
correlated closely with significantly improved progression free
survival and response to therapy. For example, at cycle 1, gene
expression analysis of CTCs isolated by the Parsortix system could
predict responders (with a survival rate of 85% at 120 days)
compared to non-responders (with a survival rate of 30% at 120
days). This pattern was repeated at all the cycle points. In the
conference poster, the researchers described this as a "landmark
analysis". This study demonstrates how gene expression analysis of
CTCs, isolated by the Parsortix system, can be used in pharma drug
trials for longitudinal patient monitoring and to guide treatment
selection.
In the second study, researchers evaluated the detection of
tumour protein p53 as a new marker for CTC detection in SCLC. p53
is coded for by the tumour suppressor gene TP53, which is mutated
in 75-90% of SCLC patients and is the target of several novel drugs
in clinical development. For the first time, the presence of p53 in
CTCs was demonstrated, suggesting that they are a unique new marker
for CTC detection. Furthermore, the presence of p53 aggregates is
likely to be a valuable biomarker for targeted treatment selection,
and of interest to pharma companies developing drugs targeting
p53.
In the third study in NSCLC, the researchers performed qPCR
molecular analysis on the CTCs captured by the Parsortix system in
samples from 118 NSCLC patients and 30 healthy volunteers. The
research demonstrated that the CTCs expressing EMT (epithelial
mesenchymal transition) and/or cancer stem cell markers were the
most clinically relevant for prognosis rather than CTCs expressing
epithelial markers. This is significant because competing
antibody-based CTC systems utilise epithelial markers for CTC
capture and miss the CTCs that do not express these markers.
In addition, in matched samples, the gene expression analysed by
qPCR of CTCs harvested by the Parsortix system was found to be more
effective at prognostic analysis (predicting overall patient
survival) than assessing the presence of epithelial CTCs.
These studies demonstrate that CTC analysis before and during
treatment can provide non-invasive monitoring of cancer patients
throughout their treatment pathway and that CTC gene expression
profiles can determine progression free survival and response to
therapy.
Ovarian cancer accounts for an estimated 21,400 cases in the
United States in 2021 and is associated with poor patient outcomes.
57% of cases are diagnosed when the cancer has already metastasised
and in these patients 5-year survival rates are just 30%. As such a
clear need exists for biomarkers which can support personalised
medicine and track patient response to optimise the care
pathway.
Lung cancer is the second most common cause of cancer in the
United States and the leading cause of cancer related mortality,
responsible for 22% of all cancer related deaths. In 2021, The
National Cancer Institute predicts that there will be a total of
236,000 new cases and 132,000 deaths - NSCLC accounts for 84% of
all lung cancer cases. Whilst the overall 5-year survival rate for
NSCLC is 25%, 60% of patients are diagnosed with metastatic (stage
IV) disease for which the 5-year relative survival rate is just 5%.
SCLC accounts for 13% of all lung cancer cases with a 5- year
survival rate of just 7%.
These studies were presented at the 5(th) ACTC conference, which
took place on 22-25 September, and may be accessed via
https://angleplc.com/library/publications/ .
Associate Professor Robert Zeillinger, Founder and Head,
Molecular Oncology Group, Dep. of Obstetrics and Gynaecology,
Medical University of Vienna commented:
"These studies further demonstrate the relevance of the
molecular characterisation of CTCs by qPCR. Our multi-marker
analysis highlights the value of gene expression analysis for
patient monitoring and determining response to therapy."
ANGLE Founder and Chief Executive, Andrew Newland, said:
"The Advances in Circulating Tumour Cells (ACTC) conference is
the pre-eminent event focused on exploring the promise of CTCs in
cancer research and patient management. ANGLE is pleased to see
further world-class research being presented by Prof. Zeillinger
and his team, which has been enabled by the Parsortix system. These
studies, including data from a large multicentre European clinical
trial, build on the growing body of evidence supporting the use of
the Parsortix system to provide cancer cells for analysis from a
simple blood test and to uncover potentially valuable new cancer
biomarkers, with the potential to guide drug development and inform
treatment decisions."
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Andrew Holder, Head of Investor Relations
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance - Carl Holmes, Simon
Hicks, Teddy Whiley
ECM - Alice Lane, Sunila de Silva +44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks +44 (0) 203 705 9330
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (United States) +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 and a downstream analysis system for cost effective,
highly multiplexed analysis of nucleic acids and proteins.
ANGLE's cell separation technology is called the Parsortix(R)
system, and it enables a liquid biopsy (a simple blood test) to be
used to provide the cells of interest 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 types of CTCs as well as
CTC clusters in a viable form (alive). CTCs enable the complete
picture of a cancer to be seen as being an intact cell they allow
DNA, RNA and protein analysis and may provide comparable analysis
to a tissue biopsy. 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.
The Parsortix system has a CE Mark in Europe for the indicated
use and, in the United States, a De Novo Submission has been made
to FDA for the Parsortix(R) PC1 system seeking FDA clearance with
Class II Classification for use with metastatic breast cancer
patients. FDA clearance is seen as the global standard. ANGLE is
seeking to be the first ever FDA cleared system for harvesting CTCs
for subsequent analysis.
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 is currently in
the process of a 200-patient clinical verification study.
ANGLE's technology for the multiplex evaluation of proteins and
nucleic acids of all types is called the HyCEAD(TM) Ziplex(R)
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 Ziplex 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
49 peer-reviewed publications and numerous publicly available
posters, available on our website.
ANGLE has established clinical services laboratories in the UK
and USA to accelerate commercialisation of the Parsortix system and
act as demonstrators to support product development. The
laboratories offer services to pharmaceutical and biotech customers
for use of the Parsortix system 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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