TIDMAGL
Angle PLC
21 January 2022
For immediate release 21 January 2022
ANGLE plc ("the Company")
PEER-REVIEWED PUBLICATION HIGHLIGHTS POTENTIAL FOR PARSORTIX
SYSTEM IN IMMUNOTHERAPY TREATMENT SELECTION
Parsortix isolation of CTCs highlights relationship between
PD-L1 expression and epithelial to mesenchymal transition (EMT)
CTCs in the process of epithelial mesenchymal transition (EMTing
CTCs) found to be most closely associated with PD-L1 expression
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that the Edith Cowan University,
Perth, Australia, has published results from a study in ovarian
cancer patients using the Parsortix(R) system. The primary aim of
this study was to demonstrate the ability to evaluate the
expression of both epithelial and mesenchymal markers, as well as
PD-L1 status, of circulating tumour cells (CTCs) isolated using the
Parsortix system, which may help to predict whether patients will
respond to immunotherapy drugs.
The Parsortix system was selected by researchers for the study
due to its ability for unbiased CTC enrichment, enabling the
isolation of both epithelial and mesenchymal cancer cells and those
in transition (EMTing-CTCs). This is clinically relevant because,
although the transition to a mesenchymal phenotype is associated
with increased metastatic potential and worse prognosis, many CTC
isolation methods, including the leading antibody-based system,
only capture epithelial cells and miss mesenchymal and EMTing
cells.
Blood from 16 ovarian cancer patients was collected and
processed using the Parsortix system. Isolated CTCs were stained
with multiple markers to determine their phenotype (epithelial,
EMTing or mesenchymal) and their PD-L1 status. CTCs were identified
in 63% of patients and, of these CTCs, 61% were exclusively
epithelial, 26% exclusively mesenchymal and 11% were positive for
both epithelial and mesenchymal markers (EMTing-CTCs). The
remaining 2% expressed the ovarian-specific marker only. Half of
the patients with detectable CTCs were PD-L1 positive. PD-L1
positive CTCs were more common amongst EMTing-CTCs, accounting for
76% of the EMTing-CTCs observed, with a significant association
between the two when compared to epithelial and mesenchymal
CTCs.
This study highlights the potential for this multi-marker
staining procedure to be useful in PD-L1 status investigation,
evaluating its utility as a biomarker to select patients for
inclusion in clinical trials that are likely to respond better to
immunotherapy treatments. Currently the proportion of patients that
respond to PD-L1 or PD-1 inhibitors is low, at around 13% to 50%,
indicating a clear need for improved patient selection as
non-responders do not benefit from treatment but risk developing
hyper-progressive disease and drug toxicity with immune-related
adverse events.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"We are pleased to report on this promising pilot data
showcasing the utility of the Parsortix system for the unbiased
isolation of multiple subsets of CTCs in ovarian cancer patients.
Whilst ctDNA is increasingly used for the stratification of cancer
patients, it is unable to provide insight into PD-L1 status. In
contrast, CTCs can provide PD-L1 status. ANGLE is currently in the
process of validating a PD-L1 assay in its clinical laboratories as
a key part of its pharma services offering for clinical
trials."
The research has been published as a peer-reviewed publication
in the Journal Cancers and 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
55 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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