TIDMAGL
Angle PLC
17 January 2022
For immediate release 17 January 2022
ANGLE plc ("the Company")
BREAKTHROUGH STUDY DEMONSTRATES FOR THE FIRST TIME CONCORDANCE
OF PARSORTIX LIQUID BIOPSY BLOOD TEST WITH INVASIVE TISSUE BIOPSY
OF THE METASTATIC SITE
Study explores key unmet medical need for metastatic breast
cancer as over 50% of patients fail to receive successful tissue
biopsies of the metastatic site preventing access to essential
information to guide their treatment
Potential for Parsortix liquid biopsy blood test as an
alternative to invasive surgical tissue biopsy in metastatic breast
cancer
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce the publication of breakthrough
research undertaken by the world-class team at the University of
Southern California Norris Cancer Center. The research demonstrates
the potential of circulating tumour cells (CTCs) harvested from a
simple blood draw using the Company's Parsortix(R) system to be
used as an alternative to invasive metastatic tissue biopsy for
metastatic breast cancer (MBC) patients.
In the United States, guidelines published by the National
Comprehensive Cancer Network (NCCN) recommend a tissue biopsy of a
secondary cancer site in MBC because of the critical need for
up-to-date information on cancer progression to guide treatment
decisions. However, over 50% of all MBC patients do not have a
successful metastatic tissue biopsy because they are either too ill
for the invasive procedure, the cancer site is inaccessible and/or
insufficient tissue is available. Hence, there is nothing to guide
ongoing treatment decisions in these patients. Even in those
patients who can undergo a metastatic tissue biopsy, there is
rarely the option for a second such biopsy, yet the cancer
continues to evolve, often to multiple sites. A simple, repeatable
liquid biopsy alternative using the Parsortix system could resolve
the issues with metastatic tissue biopsies and, as the study finds,
provide real time information on the cancer evolution to guide
treatment options.
The study was the first of its kind to directly compare
molecular analysis of matched patient samples from invasive
metastatic tissue biopsy with Parsortix-harvested cells from a
blood sample. The demonstration of a high concordance between the
RNA sequencing (RNA-Seq) results of the two sample types is
critical in demonstrating the potential utility of the Parsortix
system for use as a routine blood test for cancer patients, which
could provide a view on the spread of the disease. It is
particularly important as over 90% of patients who die of their
cancer die of the metastatic spread of the disease rather than
their primary cancer.
The pilot study, in 19 patients with MBC, investigated whether
gene expression profiling of cancer-related cells, harvested from a
blood sample with the Parsortix system, using RNA-Seq technology,
could provide insight into targetable mutations with the hypothesis
that a Parsortix system liquid biopsy could be utilised as a
surrogate biomarker to replace tissue biopsy in the analysis of
metastases. Gene expression analysis (RNA) was chosen in preference
to gene sequencing (DNA), because of major concerns that not all
DNA mutations are expressed and therefore clinically relevant
information is missed. ANGLE's Parsortix system was chosen for its
efficient, unbiased marker-independent isolation method and the
Parsortix system-harvested cells were characterised through RNA-Seq
alongside matched metastatic tissue biopsy samples.
The authors reported a high degree of concordance between
matched Parsortix system and metastatic tissue samples in
clinically actionable genes, demonstrating how the Parsortix system
could be utilised as a non-invasive, repeatable liquid biopsy to
provide real time insight into MBC disease biology and inform
targeted treatment selection. Furthermore, in three of four
patients with progressive disease, the Parsortix system-enabled
longitudinal analysis revealed a significant increase in the
complexity and frequency of expressed mutations over time. These
results indicate that the Parsortix system-enabled longitudinal
monitoring could capture changes in mutational burden as the cancer
evolves, including the development of resistance to anti-cancer
therapies which could help guide clinical decision-making and
treatment selection.
Breast cancer is the leading cause of cancer worldwide with 2.2
million new cases estimated in 2020. MBC is responsible for
virtually all breast cancer deaths and for the 6% of patients
diagnosed with metastatic disease or patients whose disease has
progressed to stage IV, 5-year relative survival is only 29%.
The research has been published as a peer-reviewed publication
in the journal Annals of Surgical Oncology and can be accessed at
https://angleplc.com/library/publications/ .
Dr Julie Lang, Chief of Breast Surgery and Co-Director of
Comprehensive Breast Cancer Program at Cleveland Clinic Cancer
Center, formerly Director, USC Breast Cancer Program, Associate
Professor of Surgery, Norris Comprehensive Cancer Center,
University of Southern California commented:
"Gene expression sequencing of Parsortix system-enriched CTCs
could lead to minimally invasive, real time diagnostic strategies
for precision therapeutic decision-making for MBC patients. Our
Parsortix-based liquid biopsy approach could serve as a surrogate
tissue biopsy to evaluate potentially clinically actionable drug
target gene expression and mutations, allowing longitudinal
assessment of the evolution of a patient's cancer for personalized
care."
ANGLE Founder and Chief Executive, Andrew Newland, added:
"ANGLE is delighted to report on this breakthrough research
published by Dr Julie Lang and her team, which clearly demonstrates
the ability to use the Parsortix system with a simple blood test as
an alternative to invasive tissue biopsy in metastatic breast
cancer. The RNA-Seq technology used allows full RNA sequencing of
the cancer providing information on the whole transcriptome.
Analysis of CTCs using RNA-Seq was a key component of our FDA
submission and we believe this form of analysis has the potential
to bring great benefit to patients through access to information to
guide treatment decisions as well as reducing the need for invasive
procedures and associated costs."
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 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
54 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.
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
NRABKQBQOBKDKDD
(END) Dow Jones Newswires
January 17, 2022 02:01 ET (07:01 GMT)
Angle (LSE:AGL)
Historical Stock Chart
From Feb 2024 to Mar 2024
Angle (LSE:AGL)
Historical Stock Chart
From Mar 2023 to Mar 2024