TIDMAGL
Angle PLC
22 September 2021
For immediate release 22 September 2021
ANGLE plc ("the Company")
STUDY DEMONSTRATES USE OF PARSORTIX TO ASSESS PD-L1 STATUS OF
CTCs IN NON-SMALL CELL LUNG CANCER PATIENTS WITH A SIMPLE BLOOD
TEST
Further evidence supporting ANGLE's decision to develop a
Parsortix-based PD-L1 assay to assess patient cancer PD-L1
status
ANGLE PD-L1 assay to be offered for use in cancer drug trials to
pharma services customers developing new immunotherapy drugs
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that the Health Research Institute
of Santiago (IDIS), Spain, has published results of a study in
patients with metastatic non-small cell lung cancer (NSCLC)
undergoing treatment with the immune checkpoint inhibitor (ICI),
pembrolizumab.
The expression of immune checkpoint proteins is dysregulated by
tumours as an immune resistance mechanism. The development of ICIs
has revolutionised the treatment of NSCLC, with National
Comprehensive Cancer Network guidelines recommending ICIs as
first-line therapy for advanced disease. Individual patient
response to PD-L1 or PD-1 inhibitors can be profound and durable.
However, the proportion of patients responding is low, ranging from
13% to 50%. As such, there is a clear need for improved patient
selection as non-responders do not benefit from the drug but also
risk developing hyper-progressive disease and drug toxicity with
immune-related adverse events. Further to this, low response rates
have led to a number of PD-L1 inhibitors being withdrawn from the
market or being unsuccessful in trials following a failure to
demonstrate statistically significant improvement in patient
population outcomes.
The current standard of care requires PD-L1 status to be
established from a tumour tissue biopsy. However, lung tissue
biopsy required for biomarker assessment is associated with
significant risks and the evolution of the tumour after initial
tissue biopsy results in this approach being a poor predictor of
treatment response as the PD-L1 status can change. Liquid biopsy
offers the potential for safe, cost-effective longitudinal
monitoring of tumour evolution and disease progression. As PD-L1
status requires the analysis of protein expression in the cell
membrane, CTCs as complete cells are the only liquid biopsy analyte
able to provide this.
IDIS's study was limited to investigating epithelial CTCs in
patient blood and demonstrated that the Parsortix system could be
used to recover CTCs from NSCLC patient blood for investigation of
their PD-L1 status prior to receiving immunotherapy targeting this
pathway. All patients where the Parsortix system recovered
epithelial CTCs had at least some PD-L1-expressing epithelial CTCs.
Thus, the approach taken by the researchers of classifying patients
as PD-L1 positive if they had any PD-L1 positive cells could not
differentiate likely response to the immune checkpoint inhibitor,
since all patients had some PD-L1 positive cells.
ANGLE has been working internally to develop a robust Parsortix
assay for PD-L1 covering all phenotypes of CTCs including
epithelial, mesenchymal and CTCs undergoing epithelial mesenchymal
transition (EMT) as well as CTC clusters. This will provide a
scoring mechanism by determining the proportion of CTCs with PD-L1
protein expression allowing discrimination between different
patient groups. Once this assay is finalised, the aim is to use it
to identify likely responders to immunotherapy drugs. ANGLE expects
to collaborate with IDIS, Spain and other leading cancer centres in
validation of this assay.
Early evaluation of a patient's response to immunotherapy might
enable clinicians to decide if the clinical benefit is sufficient
to continue treatment, or to stop treatment, thereby avoiding
unnecessary toxicities and costs and allowing alternative treatment
to commence sooner.
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 84% 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%.
There are numerous cancer drug trials in progress or being
planned in support of new immunotherapy drugs for these patients.
All these drug trials could benefit from a Parsortix-based PD-L1
assay for longitudinal monitoring of patients and this will be a
key focus for ANGLE's pharma services offering.
The research has been published as a peer-reviewed publication
in the journal Molecular Oncology and may be accessed via
https://angleplc.com/library/publications/ .
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"ANGLE is pleased to see continued efforts being made to better
identify patients who will respond well to immune checkpoint
inhibitors (ICIs). Whilst ICIs have revolutionised metastatic NSCLC
patient care, they are costly and associated with significant side
effects. We have made substantial progress in the development of
our Parsortix-based PD-L1 assay and are offering this to our pharma
services customers. In addition, we are planning to investigate its
utility in guiding immunotherapy treatments with the aim of
offering the assay as a laboratory developed test from our clinical
laboratories for patient management."
For further information:
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 +44 (0) 203 705 9330
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (United States) +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 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
49 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 the Parsortix system 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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