TIDMAGL
Angle PLC
01 December 2021
For immediate release 1 December 2021
ANGLE plc ("the Company")
ANGLE'S PARSORTIX SYSTEM KEY TO STUDY DEMONSTRATING RNA ANALYSIS
OF CTCs AS A PROGNOSTIC TOOL IN NON-SMALL CELL LUNG CANCER (NSCLC)
PATIENTS
Research published by world-class cancer research centre
highlights critical advantages of the Parsortix system
Multi-marker transcriptomic analysis (RNA) of CTCs reveals
multiple subtypes with different prognostic significance
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce the publication of new clinical
research undertaken by the world-class team at the Medical
University of Vienna, Austria. The study in Non-Small Cell Lung
Cancer (NSCLC) patients utilised ANGLE's Parsortix(R) system to
isolate circulating tumour cells (CTCs) for enumeration and gene
expression analysis (RNA). The Parsortix system was selected by
researchers for the study due to its ability to provide unbiased
CTC enrichment enabling the isolation of non-epithelial cancer
cells together with exceptional depletion of white blood cells,
which is key for molecular analysis.
In preliminary spiking experiments, CTC capture rates for the
Parsortix system were established with two NSCLC cell lines spiked
into healthy volunteer blood. Capture rates as high as 80% were
observed, further confirming the high capture rates observed in
previous studies. Blood was then collected either at baseline or at
disease progression in 118 NSCLC patients and processed with the
Parsortix system. The cells harvested by the Parsortix system were
subjected to RNA molecular analysis using standard downstream
analysis techniques to generate gene expression information.
The researchers report that in patients where a subset of CTCs
had cancer stem cell (CSC) properties, significantly worse patient
outcomes both at diagnosis and at disease progression were
observed. CSCs are non-epithelial CTCs with a high degree of cell
plasticity and heterogeneity making them highly adaptable and
resistant to treatment and potentially representing a new avenue
for drug discovery. Notably, competing antibody-based CTC systems
fail to capture the clinically significant non-epithelial CTCs.
This study highlights the relevance of CTCs, harvested from a
simple blood test using ANGLE's Parsortix system, as a tool for the
clinical management of NSCLC. In addition to the prognostic value
of certain subsets of CTCs, CTCs offer potentially useful clinical
information, such as PD-L1 protein expression, as well as insight
into the entire molecular profile of a tumour at the time of
sampling.
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 2021, The
National Cancer Institute predicts that there will be a total of
236,000 new cases and 132,000 deaths - NSCLC accounts for 85% 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%.
One in five patients will experience an adverse event following a
lung tissue biopsy. As such, the costs are significant, with a mean
cost of US$14,634 rising to US$37,745 in patients with
complications.
Professor Robert Zeillinger, Head of Molecular Oncology Group,
Comprehensive Cancer Center, Medical University of Vienna, Austria,
commented:
"This study further underlines the relevance of the molecular
characterisation of CTCs. Our multi-marker analysis highlighted the
prognostic value of cancer stem cell-related transcripts at primary
diagnosis and disease progression. In the age of immunotherapy,
CTCs may offer potentially useful clinical information at the
cellular level, for example PD-L1 gene expression before treatment,
at treatment and during follow-up."
ANGLE Founder and Chief Executive, Andrew Newland, added:
"Whilst ctDNA, which is derived from fragments of dead cells,
has become a widely utilised tool for the stratification of NSCLC
patients, it is limited to analysis of DNA alone. Intact living
CTCs harvested using the Parsortix system allow for analysis of key
protein targets for drug therapy, such as PD-L1 status, in addition
to gene expression profiling (RNA) for any gene of interest. Gene
expression analysis is becoming increasingly recognised as critical
in understanding the true nature of a patient's cancer. In
contrast, analysis of DNA mutations alone may fail to identify the
correct patients for targeted treatment, as the genes containing
these mutations may not actually be expressed.
Additionally, this research further underpins our confidence in
the growth of our pharma services business, where longitudinal
analysis of CTCs promises to increase the efficiency and lower the
costs of clinical trials in oncology."
The research has been published as a peer-reviewed publication
in the Journal of Personalised Medicine, 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, Jen Clarke, Milo Bonser, Shiv Dave +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 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 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
51 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 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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