TIDMAGL
Angle PLC
24 October 2022
For immediate release 24 October 2022
ANGLE plc ("the Company")
PARSORTIX POSTER PRESENTED AT INTERNATIONAL SOCIETY OF LIQUID
BIOPSY MEETING
Study demonstrates ability to analyse both CTCs and ctDNA from
the same sample
Value of multimodal analyte analysis in liquid biopsy gaining
recognition and momentum
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce it presented results from a proof
of concept study at the International Society of Liquid Biopsy
meeting in Miami, Florida on 20-22 October 2022. The study
demonstrated that both circulating tumour cells (CTCs) and
cell-free circulating tumour DNA (ctDNA) can be analysed from a
single blood sample. The results show that removal of plasma from
blood samples for circulating tumour DNA (ctDNA) analysis does not
impact on the number or quality of circulating tumour cells (CTCs)
which can be successfully isolated from the same sample using the
Parsortix(R) system.
Liquid biopsy, utilising CTCs and ctDNA, has the potential to
characterise cancer at genetic, transcriptional, and protein levels
simultaneously. This is not achievable with a single-timepoint
tissue biopsy or with ctDNA alone since ctDNA does not allow for
RNA sequencing or protein analysis. Several studies have assessed
the value of combining multiple blood-based analytes for informing
on a variety of oncological conditions including, but not limited
to, lung cancer and metastatic breast cancer. These studies
conclude that multimodal assessment, including dual analyte
analysis of CTCs and ctDNA, can provide complementary information
valuable for prognostic, therapy selection and patient monitoring
purposes.
This study aimed to establish a workflow to allow the isolation
of both ctDNA and CTCs from a single blood sample. Both spiked cell
samples (blood samples collected from eight healthy volunteers
spiked with cultured cancer cells) and 13 metastatic breast cancer
(MBC) patient samples were included in the study. Two blood samples
were taken from each donor or patient and samples were run in
parallel down each workflow; plasma was removed by centrifugation
of one sample per donor (for ctDNA analysis), whilst the other
sample was not centrifuged (plasma remained in the sample). The
cellular component left in each centrifuged tube was resuspended in
solution and then processed using the Parsortix system and CTCs
detected via immunofluorescence.
In the spiked healthy volunteer samples, the percentage of CTCs
detected was comparable between samples processed with and without
plasma. This finding was confirmed in the MBC samples; CTCs were
identified in 39% of patient samples with matched findings for both
workflows. Similarly, the number and size of CTC clusters were
equivalent in both samples with and without plasma.
This study demonstrates the feasibility of combining CTC
isolation using the Parsortix system with plasma removal for
subsequent ctDNA analysis from a single tube of blood with minimal
additional sample handling. This opens the possibility for clinical
laboratories to broaden the clinical utility of their assays and
maximise the value of each patient's sample. Despite the emerging
realisation of the benefit of a combinatorial approach to blood
analysis, the logistics revolving around access to both a CTC
enrichment platform and a ctDNA sequencing platform at the same
site has so far limited such analysis. ANGLE believes there will be
significant demand from biopharma companies for an assay that
combines ctDNA and CTCs. The workflow presented, demonstrating
effective CTC isolation utilising the Parsortix system with
concurrent removal of plasma for ctDNA analysis, puts ANGLE in a
highly competitive position in this emerging arena.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"We are pleased to share the results of our own in-house
research which further showcases the utility of the Parsortix
system for the unbiased isolation of CTCs which, in combination
with plasma removal, allows for the additional analysis of ctDNA.
Although ctDNA is established in the US market for targeted
treatment selection, CTCs provide information that is both
complementary and additional to that which can be provided using
ctDNA alone. This is recognised by the National Cancer Institute,
who highlight the unmet need for transcriptional and protein
analysis to truly enable precision medicine."
The research 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
circulating tumor cell (CTC) harvesting technology is known as the
Parsortix(R) system.
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 three separate 200 subject clinical
studies under a programme designed to develop an ovarian cancer
pelvic mass triage test, with the results showing best in class
accuracy (AUC-ROC) of 95.4% with sensitivity of 90% and specificity
of 93%. This excellent clinical result demonstrates the utility of
cells harvested by the Parsortix system, which the Company believes
is the "best sample" for liquid biopsy analysis as it recovers
intact, living cancer cells that are involved in the progression of
the disease providing prospective information.
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
70 peer-reviewed publications and numerous publicly available
posters from 33 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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