TIDMAGL
Angle PLC
12 April 2021
For immediate release 12 April 2021
ANGLE plc ("the Company")
ANGLE'S PARSORTIX SYSTEM SHOWCASED IN POSTER PRESENTATIONS AT
LEADING CANCER CONFERENCE
Publication of study results demonstrating the capabilities of
two new assays in clinical samples at AACR 2021
Immunotherapy assay enables determination of PD-L1 status in
significant proportion of patients and could guide personalised
treatment selection
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that two poster presentations
showcasing the Parsortix(R) system are being presented at the
American Association for Cancer Research Conference (AACR) 2021,
being held as a virtual meeting on 10-15 April 2021 and then 17-21
May 2021. These posters present findings from key studies
undertaken as part of ANGLE's clinical development programme.
The first poster, "Mesenchymal markers: the new avenue for
circulating tumour cells detection", reports on the performance of
ANGLE's new epithelial-to-mesenchymal transition (EMT) assay to
isolate and identify both epithelial and mesenchymal circulating
tumor cells (CTCs) in 47 metastatic breast cancer (MBC) and 48
non-small cell lung cancer (NSCLC) patients.
Unlike tissue biopsy, a liquid biopsy harvesting CTCs from
peripheral blood allows the routine, repeat testing and
characterisation of cancer at genetic (DNA), transcriptional (RNA)
and protein levels. Most CTC isolation systems, including the
market leader, are based on epitope-dependent CTC capture using
epithelial markers. However, it is known that tumour cells can
undergo EMT resulting in these clinically relevant cells being
missed by epitope-dependent systems. ANGLE's Parsortix system
addresses this major limitation in other systems by its
epitope-independent proprietary approach to capture all phenotypes
of cancer cell in the blood circulation.
This study highlighted the importance of the inclusion of
mesenchymal markers into CTC characterisation, as 25-38% of CTCs
captured by the Parsortix system expressed mesenchymal markers
which would have been missed with an epithelial-only based
approach. In addition, 59%-74% of CTCs had both epithelial and
mesenchymal markers and were therefore undergoing EMT whilst only
1-3% of CTCs were purely epithelial.
ANGLE's EMT assay showed a high degree of analytical sensitivity
(97-98%) and specificity (96-98%) in spiking experiments and these
findings were confirmed in patient samples (96% specificity).
The second poster "Investigation of PD-L1 expression in
circulating tumour cells isolated using the Parsortix system in
metastatic lung and breast cancer patients" showcases ANGLE's
programmed death-ligand 1 (PD-L1) assay.
PD-L1 is a protein thought to play a major role in
immuno-oncology, allowing many cancers to evade the host immune
system when upregulated. Immunotherapy drugs known as PD-L1
inhibitors are showing excellent therapeutic results in multiple
cancers for some patients. However, these drugs are expensive at
some $170,000 per treatment and only work in 30% of patients
highlighting the need for companion diagnostics to enable targeted
patient selection. The measurement of PD-L1 expression from CTCs
offers the potential to identify patients who might respond to such
immunotherapy drugs and, importantly, to monitor patients on these
therapies using a drug-specific target.
ANGLE's study in 17 MBC and 18 metastatic NSCLC patients found
CTCs in 70% and 55% of patients respectively. No CTCs were found in
17 healthy volunteers, confirming high specificity. The PD-L1 assay
allowed for definitive identification of PD-L1 positive and PD-L1
negative status in a high proportion of patients with CTCs (72% of
MBC and 60% of NSCLC) with the remaining patients having a mix of
PD-L1 positive and PD-L1 negative CTCs. This lays the groundwork
for the further refinement of the assay to enable dynamic PD-L1
monitoring in patients during the course of their treatment and
follow-up.
The successful detection of PD-L1 CTC status in MBC and NSCLC
opens the potential for collaboration with leading pharma companies
with immunotherapy drugs in development. There are over 2,000
PD-L1/PD-1 interventional trials registered on clinicaltrials.gov,
enrolling over 300,000 patients, which would be potential targets
for ANGLE's pharma services business.
The global PD-L1 inhibitor market is estimated to be valued at
US$22bn and is growing at >40% per annum.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"We are pleased to present promising data showcasing new
"sample-to-answer" applications for ANGLE's Parsortix system at
AACR, a leading international cancer conference. Future drug trials
of immune checkpoint inhibitors will be targets for adoption of the
Parsortix PD-L1 assay and ANGLE is developing a pharma services
capability to process these types of trial samples for multiple
such biomarkers on a commercial scale.
ANGLE recently launched clinical services laboratories in the UK
and United States, and is in advanced discussions with potential
customers for the deployment of the Parsortix system in cancer drug
clinical trials. We look forward to updating the market on the
first contracts in due course . "
Both published posters are available at
https://angleplc.com/library/publications/ .
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 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
41 peer-reviewed publications and numerous publicly available
posters, available on our website.
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