TIDMAGL
Angle PLC
27 May 2022
For immediate release 27 May 2022
ANGLE plc ("the Company")
PARSORTIX ENABLES MOLECULAR CHARACTERISATION OF CTCS ISOLATED
FROM FROZEN SAMPLES IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND
SARCOMA
Parsortix system harvests intact CTCs for single-cell whole
genomic sequencing from frozen and fresh blood samples with the
same efficiency
Detection of druggable mutations in CTCs enriched from frozen
samples may aid treatment decisions in the clinical setting
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 work undertaken in advanced
non-small cell lung cancer (NSCLC) and sarcoma patients. The
institute demonstrated that the Parsortix(R) system could
successfully isolate circulating tumour cells (CTCs) from frozen
peripheral blood mononuclear cell (PBMC) samples. PBMC samples
contain any blood cell with a nucleus, including white blood cells
and CTCs, but has been depleted of red blood cells which do not
have a nucleus. The potential ability to process frozen samples
could allow for retrospective analyses and improve sample sharing
capabilities in multicentre studies.
Isolated CTCs were stained to assess phenotype and identify CTCs
for single cell retrieval, followed by low-pass copy number
analysis through whole genome sequencing. In addition, CTCs were
analysed for clinically actionable mutations by digital PCR.
The Parsortix system was selected for its ability to harvest
CTCs from mesenchymal tumours, such as sarcoma, and CTCs that have
undergone epithelial to mesenchymal transition, as may occur in
NSCLC. This is clinically relevant because, although the transition
to a mesenchymal phenotype is associated with increased metastatic
potential and worse prognosis, many CTC isolation methods,
including the leading antibody-based system, only identify cells
expressing epithelial markers .
CTCs could be isolated with the same efficiency from both fresh
blood samples and frozen PBMCs. Subsequent automated single-CTC
retrieval allowed the authors to identify CTCs based on their
abnormal DNA copy number profiles, of which a similar number of
CTCs were identified in both fresh and frozen samples. Long-term
freezing of samples (1-3yrs), from NSCLC patients, had no
detrimental effect on CTC isolation or identification. This study
also showed that the majority of CTCs isolated were non-epithelial,
further highlighting the importance of marker-independent CTC
isolation.
Importantly, CTCs isolated from frozen NSCLC patient PBMCs using
the Parsortix system were analysed for epidermal growth factor
receptor (EGFR) mutations, with results showing good concordance
with the primary tissue. Analysis and the potential to track
druggable mutations, such as EGFR, in CTCs from frozen PBMC samples
over multiple time points may help inform treatment decisions and
investigate therapy response in the clinical setting, in a
retrospective manner.
Dr Giulia Bertolini and Dr Vera Cappelletti, Department of
Experimental Oncology, National Cancer Institute of Milan,
commented:
"This study demonstrates the feasibility of CTC analyses in
cryopreserved PBMCs and represents an advance in blood sample
management for CTC studies, allowing for a better selection of
informative time points to longitudinally investigate tumor
progression/response to therapy thereby enabling retrospective
studies."
ANGLE Founder and Chief Executive, Andrew Newland, added:
"We are pleased to report on the use of the Parsortix system for
the unbiased isolation and molecular characterisation of CTCs from
frozen PBMC samples with similar success as from fresh blood
samples. This approach may help facilitate studies that require
time-dependent sampling or are completed across multiple centres.
DNA analysis of the cancer cells harvested by the Parsortix system
offers the potential to track druggable mutations in CTCs as an aid
to future treatment decisions for patients with NSCLC."
The research has been published as a peer-reviewed publication
in the Journal Clinical Chemistry 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
60 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.
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