TIDMAGL
Angle PLC
25 March 2022
For immediate release 25 March 2022
ANGLE plc ("the Company")
PARSORTIX SHOWS POTENTIAL FOR IDENTIFYING THERAPEUTIC TARGETS IN
PATIENTS WITH TRIPLE NEGATIVE BREAST CANCER
Parsortix system harvests intact CTCs for whole genome
sequencing identifying multiple actionable targets
Both tumour and CTC samples after pre-surgical chemotherapy show
alterations in genes involved in drug resistance
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that a leading cancer research
institute, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan,
Italy, has published results of a study undertaken in early stage
triple negative breast cancer (TNBC) patients undergoing
neoadjuvant chemotherapy (NAC; chemotherapy administered before
surgery).
Researchers used ANGLE's Parsortix(R) system to isolate
circulating tumour cells (CTCs) before, during and after NAC
treatment, alongside the collection of primary tumour tissue
samples pre- and post-treatment, to analyse for copy number
alterations (CNAs), through whole genome sequencing and targeted
sequencing, respectively.
Using ANGLE's marker-independent Parsortix system to harvest
CTCs, followed by automated single-CTC retrieval, the authors
identified and analysed both epithelial and non-epithelial CTCs,
allowing characterisation of CTCs that would not have been detected
by epithelial antibody-based approaches. Analysis of CTCs before,
during and after NAC treatment allowed the researchers to track the
individual evolution of a patient's TNBC, revealing
treatment-induced resistance to the chemotherapy as well as the
identification of newly acquired genetic changes that could provide
additional treatment options. In two patients, CTCs collected after
NAC treatment shared more genomic alterations with the residual
tumour, i.e. post-NAC treatment, compared to the primary
tumour.
This study demonstrates how CNA analysis of CTCs harvested by
the Parsortix system, from early stage TNBC patients pre- and
post-NAC treatment, has the potential to provide information on
tumour evolution and identify actionable therapeutic targets that
could help determine future treatment options for patients with
chemotherapy-resistant disease.
In the United States, breast cancer is the most frequently
diagnosed cancer in women with 287,000 new cases expected in 2022,
accounting for 31% of all new cancer cases. The American Cancer
Society estimates that TNBC accounts for about 10-15% of all breast
cancers. TNBC differs from other types of invasive breast cancer in
that it grows and spreads faster, has limited treatment choices,
and a worse prognosis.
Dr Vera Cappaletti, Biomarkers Unit, Department of Experimental
Oncology, National Cancer Institute of Milan, commented:
"The extreme heterogeneity of triple negative breast cancer has
led to difficulties in finding suitable molecular targets. This has
resulted in limited benefit from targeted therapies observed in
clinical trials. Implementing longitudinal monitoring, through
liquid biopsy of CTCs, is a crucial step for improving treatment
efficacy and represents an optimal approach to be pursued in future
studies to implement personalized medicine."
ANGLE Founder and Chief Executive, Andrew Newland, added:
"We are pleased to report on the use of the Parsortix system for
the unbiased isolation of both epithelial and mesenchymal CTCs in
TNBC, uncovering potential new therapeutic targets. ANGLE's ability
to provide actionable insights could help patients with limited
treatment options and should prove highly attractive to drug
developers looking for new approaches for hard-to-treat cancers,
such as TNBC."
The research has been published as a peer-reviewed publication
in the Journal Scientific Reports 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
56 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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