TIDMAGL
RNS Number : 2825A
Angle PLC
01 June 2021
For immediate release 1 June 2021
ANGLE plc ("the Company")
BREAKTHROUGH RESEARCH SUPPORTS POTENTIAL USE OF PARSORTIX IN
PREVENTION OF RELAPSE OF BREAST CANCER PATIENTS IN REMISSION
Parsortix system successfully used to harvest cancer cells
"hibernating" in the bone marrow of breast cancer patients
Parsortix enrichment of these cancer cells found to
significantly enhance RNA sequencing analysis enabling the
identification of clinically relevant biomarkers, which may lead to
targeted treatment to eradicate these cells
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce the publication of pivotal
research by Washington University School of Medicine, St. Louis,
Missouri, United States into the utility of the Parsortix(R) system
to isolate rare cancer cells present in the bone marrow (known as
Disseminated Tumour Cells, or DTCs) of breast cancer patients.
Analysis of DTCs in breast cancer patients may help to inform
treatment decisions and potentially prevent relapse for patients in
remission.
Breast cancer is the most prevalent cancer in women worldwide.
There is a lifetime risk of a woman developing breast cancer of
some 13%. In the United States alone, there are approximately 3.7
million women alive previously diagnosed with breast cancer.
Despite new treatment options and advances in patient management
protocols, some 25% of women previously diagnosed with breast
cancer will, often after many years of remission, relapse and die
of their cancer within 20 years of diagnosis.
DTCs "hibernating" in the bone marrow are believed to be the
progenitors of distant metastatic cancer relapse when some event,
currently not understood, stimulates them to re-enter the blood
circulation causing distant metastatic spread of the cancer. There
is a critical need to identify and molecularly characterise these
rare cells, with the ambition to develop targeted treatments to
prevent DTCs progressing to a metastatic site.
The Parsortix system was evaluated alongside multiple other
approaches and found to be the most effective for harvesting DTCs,
which are highly heterogeneous rare cells. The Parsortix system was
able to repeatably achieve a 1,000-fold enrichment of DTCs for gene
expression analysis by droplet-digital PCR and significantly
enabled single cell RNA sequencing and population-based molecular
profiling of these rare cells.
Furthermore, the Parsortix system was found to have several
other advantages over alternative approaches investigated including
ease of operation, minimal handling of samples and easy recovery of
viable cells. The researchers concluded that the Parsortix system
will enable further research into the diverse molecular phenotypes
of DTCs, supporting the development of novel treatments and
treatment protocols to eradicate these cells to prevent distant
disease development in breast cancer patients.
The research has been published as a peer-reviewed publication
PLoS One and can be accessed via
https://angleplc.com/library/publications/ .
Professor Rebecca Aft from the Department of Surgery, Washington
University School of Medicine, St. Louis, Missouri, United States
commented:
"We report that the Parsortix system, an automated size and
flow-based CTC enrichment platform can be successfully used to
enrich DTCs from the bone marrow of breast cancer patients. We
demonstrated recovery, enrichment, and downstream molecular
analysis like that achieved with blood. We found that enriched DTCs
were sufficient in number and viability to serve as a template for
single cell RNA sequencing analysis and biologically and clinically
relevant breast cancer expression profiles were detected. The
Parsortix system now makes it possible to molecularly interrogate
heterogeneous (including EpCAM negative or low EpCAM expression)
DTCs using this system and uncover important new biomarkers that
could provide a basis for targeted treatments."
Mark Watson, Associate Professor, Pathology and Immunology, Div.
of Laboratory and Genomic Medicine, Washington University School of
Medicine, St. Louis, Missouri, United States added:
" It is our most fervent research objective to demonstrate with
rigorous, peer-reviewed research data that a system such as
Parsortix could be used to routinely enrich, identify, and classify
occult tumor cells in the bone marrow of breast cancer patients to
develop personalized, long-term therapeutic strategies to prevent
disease progression and mitigate distant metastatic spread for
improved long-term survival."
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"DTC presence in bone marrow has been shown in multiple studies
to be predictive of clinical relapse. The risk of recurrence varies
significantly by cancer type and many cancer survivors fear
recurrence. Investigation and eradication of DTCs could greatly
reduce the risk of relapse for breast cancer patients in remission.
This work from the Washington University School of Medicine may
provide a new avenue for the treatment of cancer and we are
delighted that our Parsortix system is enabling this new
approach."
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 (US) +1 (212) 850 5624
The information communicated in this announcement is inside
information for the purposes of Article 7 of Regulation
596/2015.
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 HyCEADTM 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
44 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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