TIDMAGL
Angle PLC
16 June 2022
For immediate release 16 June 2022
ANGLE plc ("the Company")
PARSORTIX SYSTEM DEMONSTRATES POTENTIAL IN PREDICTING
IMMUNOTHERAPY RESPONSE IN SMALL CELL LUNG CANCER
CTCs isolated by the Parsortix system can be used to evaluate
PD-L1 expression
Marker independent isolation of CTCs enables isolation of both
EpCAM-negative and positive CTCs from small cell lung cancer
patients
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 small cell
lung cancer (SCLC) patients using the Parsortix(R) system. The
primary aim of this study was to demonstrate the ability to
evaluate the PD-L1 status of isolated circulating tumour cells
(CTCs), providing an alternative sample than solid tissue in SCLC,
which may help to predict response to immunotherapy.
The Parsortix system was selected by researchers for the study
due to its ability for unbiased CTC enrichment enabling the
isolation of both EpCAM-positive and EpCAM-negative cancer cells.
This is clinically relevant because, although there is an abundance
of high EpCAM expressing CTCs in the SCLC population, EpCAM
expression can be lost or downregulated during cancer progression.
This progression is associated with increased metastatic potential
and worse prognosis, but still many CTC isolation methods,
including the leading antibody-based system, only isolate and
identify cells expressing the EpCAM marker.
Blood collected from 18 SCLC patients was processed using the
Parsortix system (20 samples; 18 samples collected prior to
treatment for all patients, with two patients also providing
samples at relapse). CTCs were identified in 50% of the samples,
from ten of the 18 SCLC patients. The researchers found
EpCAM-negative CTCs in three patients, with a small proportion of
the CTCs identified also positive for PD-L1 expression. Of the ten
CTC-positive patient samples, four samples (40%) had PD-L1-positive
CTCs.
This study demonstrates both the ability of the Parsortix system
to isolate EpCAM-negative and positive CTCs from SCLC patient
samples and how isolated CTCs can be used to quantify PD-L1
expression. This shows the potential of CTCs harvested from a
simple blood sample as an alternative to a tissue sample for PD-L1
evaluation in the SCLC population, with the possibility to provide
an indication on the likelihood of a patient response to
immunotherapy. Currently the proportion of cancer patients that
respond to PD-L1 or PD-1 inhibitors is low, ranging from 13% to
50%, yet the cost of treatment is c.$170,000. This highlights a
clear need for improved patient selection as non-responders risk
developing hyper-progressive disease and suffering from drug
toxicity with immune-related adverse events.
Lung cancer is the second most common cancer in the United
States. The National Institutes of Health predicts that there will
be a total of 235,000 new cases in 2022 with a similar incidence in
men and women. Lung cancer is the leading cause of cancer related
mortality, accounting for 21% of all cancer deaths, estimated at
130,000 people in 2022. SCLC accounts for approximately 14% of lung
cancer cases. Prognosis for SCLC patients is extremely poor with a
5-year survival rate of only 7% and a median overall survival of
just 8.5 months. Improved patient selection for targeted treatment
and immunotherapy is urgently needed to improve outcomes.
Associate Professor Elin Gray, School of Medical and Health
Sciences, Edith Cowan University, commented:
"The current findings extend our knowledge of the ability of
epitope-independent technologies to detect subsets of CTCs. The
study demonstrates that PD-L1 expression can be quantified on CTCs
detected in SCLC patients. This could potentially serve as a marker
to evaluate the likelihood of anti-PD-1 therapy response."
ANGLE Founder and Chief Executive, Andrew Newland, added:
"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 SCLC patients and in doing
so providing a sample that allows quantification of PD-L1
expression in this population. This publication is well-timed given
that ANGLE is currently in the process of developing 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 Translational Lung Cancer Research 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, Ciaran Walsh, Milo Bonser +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 known as the Parsortix(R) system and a downstream
analysis system for cost effective, highly multiplexed analysis of
nucleic acids and proteins.
ANGLE's Parsortix(R) system is FDA cleared for its intended use
in metastatic breast cancer and is currently the first and only FDA
cleared medical device to harvest intact circulating cancer cells
from blood.
Intended use
The Parsortix(R) PC1 system is an in vitro diagnostic device
intended to enrich circulating tumor cells (CTCs) from peripheral
blood collected in K(2) EDTA tubes from patients diagnosed with
metastatic breast cancer. The system employs a microfluidic chamber
(a Parsortix cell separation cassette) to capture cells of a
certain size and deformability from the population of cells present
in blood. The cells retained in the cassette are harvested by the
Parsortix PC1 system for use in subsequent downstream assays. The
end user is responsible for the validation of any downstream assay.
The standalone device, as indicated, does not identify, enumerate
or characterize CTCs and cannot be used to make any
diagnostic/prognostic claims for CTCs, including monitoring
indications or as an aid in any disease management and/or treatment
decisions.
The Parsortix system enables a liquid biopsy (a simple blood
test) to be used to provide the circulating metastatic breast
cancer cells 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 phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as
well as CTC clusters in a viable form (alive). CTCs harvested from
the system enable a complete picture of a cancer to be seen; as
being an intact cell they allow DNA, RNA and protein analysis as
well as cytological and morphological examination and may provide
comparable analysis to a tissue biopsy in metastatic breast cancer.
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.
In the United States, the Parsortix(R) PC1 system has received a
Class II Classification from FDA for use with metastatic breast
cancer patients. FDA clearance is seen as the global gold standard.
ANGLE's Parsortix system is the first ever FDA cleared system for
harvesting CTCs for subsequent analysis. ANGLE has applied the IVD
CE Mark to the same system for the same intended use in Europe.
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
62 peer-reviewed publications and numerous publicly available
posters from 31 independent cancer centres, available on our
website.
ANGLE has established clinical services laboratories in the UK
and the United States to accelerate commercialisation of the
Parsortix system and act as demonstrators to support product
development. The laboratories offer services globally 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.
This information is provided by Reach, the non-regulatory press
release distribution service of RNS, part of the London Stock
Exchange. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
Reach is a non-regulatory news service. By using this service an
issuer is confirming that the information contained within this
announcement is of a non-regulatory nature. Reach announcements are
identified with an orange label and the word "Reach" in the source
column of the News Explorer pages of London Stock Exchange's
website so that they are distinguished from the RNS UK regulatory
service. Other vendors subscribing for Reach press releases may use
a different method to distinguish Reach announcements from UK
regulatory news.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
NRAFAMTTMTTBTMT
(END) Dow Jones Newswires
June 16, 2022 02:00 ET (06:00 GMT)
Angle (LSE:AGL)
Historical Stock Chart
From Apr 2024 to May 2024
Angle (LSE:AGL)
Historical Stock Chart
From May 2023 to May 2024