TIDMAGL
Angle PLC
29 January 2021
For immediate release 29 January 2021
ANGLE plc ("the Company")
MAJOR EUROPEAN CONSORTIUM PUBLISHES RESULTS OF LARGE-SCALE
INVESTIGATION DEMONSTRATING KEY ADVANTAGES OF parsoRtix system in
lung cancer
Parsortix system demonstrates high capture rate of CTCs
irrespective of biomarker status or phenotype
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce the publication of a five year
programme of work undertaken by the CANCER-ID Consortium to
establish the performance and technical capabilities of five
circulating tumour cell (CTC) isolation platforms, in which key
advantages of the Parsortix(R) system were identified. The
CANCER-ID consortium is supported by Europe's Innovative Medicines
Initiative (IMI) and is a Europe-wide Public-Private-Partnership
aimed at the establishment of standard protocols for, and clinical
validation of, blood-based biomarkers in order to drive wide
adoption of liquid biopsy in clinical practice and pharma
services.
CTCs are cancer cells present in the blood stream, which can be
harvested from a simple blood test, providing minimally invasive
access to solid tumours. In their latest research, the Consortium
highlights that, when compared to other circulating biomarkers, the
clear advantage of harvested CTCs is that they provide insight into
RNA expression and proteins, which might provide additional detail
to help inform more rational treatment decisions than ctDNA alone.
As such, CTCs have the potential to develop superior assays for
detection, analysis, and treatment of systemic cancer.
The group selected non-small cell lung cancer (NSCLC) cell lines
for its initial focus because of the large number of available
targeted therapies. This creates a need for predictive biomarkers
to stratify patients and monitor treatment response. CTCs could be
a valuable source of such relevant biomarkers. Two cell lines were
used with a strong difference in both epithelial marker (EpCAM)
expression (to test marker-dependent and marker independent
platforms) and size (to test size-dependent isolation methods).
The research has shown that Parsortix performance was robust,
with mean cell capture rates of 71% (EpCAM high cell line) and 67%
(EpCAM low cell line). In comparison, the leading FDA approved
antibody-based CTC system was unable to enrich EpCAM low cells.
Parsortix was comparable to the leading antibody-based system with
respect to time required for sample processing, staining and cell
identification and was considerably faster than some other systems.
The use of Transfix(R) blood collection tubes, utilised with
Parsortix in this study, provided for 5 days' blood stability
enhancing the practicability of sample management.
The research, which has been published in the peer-reviewed
journal Clinical Chemistry , may be accessed via
https://angleplc.com/library/publications/ .
Nikolas Stoecklein, Professor for Experimental Surgical Oncology
at Heinrich-Heine University, Düsseldorf, Germany commented:
"This multi-national proficiency testing of CTC-enrichment
technologies has importance in the establishment of guidelines for
clinically applicable preanalytical workflows and the definition of
minimal performance qualification requirements prior to clinical
validation of technologies. It will remain in operation beyond the
funding period of CANCER-ID, in the context of the European Liquid
Biopsy Society (ELBS)."
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"CANCER-ID is a large scale industrial and government consortium
in Europe seeking to accelerate adoption of liquid biopsy solutions
in cancer care by standardising protocols. We are pleased that
published results of their work over the last five years highlight
the advantages of analysing CTCs compared to other liquid biopsy
approaches and identify specific advantages of ANGLE's Parsortix
system CTC solution.
We look forward to harnessing Parsortix's unique capabilities as
we continue to make strong progress with the establishment of
approved clinical laboratories to support the use of the Parsortix
system for pharma services and subsequent clinical deployment for
clinical use. As previously announced, the Parsortix system has
been submitted to FDA, seeking the first ever FDA product clearance
for a system that harvests cancer cells from a simple blood draw
for subsequent analysis."
For further information ANGLE:
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, Andrew Craig,
Chris Lee +44 (0) 203 705 9330
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 CANCER-ID CANCER-ID - Innovation in Medicine (cancer-id.eu)
CANCER-ID was a European consortium funded by the Innovative
Medicines Initiative (IMI) aimed at the establishment of standard
protocols for and clinical validation of blood-based biomarkers. It
brought together experts from academic and clinical research,
innovative Small-to-Medium sized Enterprises (SMEs), diagnostics
companies and the pharmaceutical industry thus providing a unique
setting for establishing clinical utility of "liquid biopsies".
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 thus 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. In addition, the live CTCs harvested can be cultured, which
offers the potential for testing 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
39 peer-reviewed publications and numerous publicly available
posters, available on our website.
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