RCS - Angle PLC - Parsortix poster presented at ISLB meeting

AngleAnnouncement

24/10/2022 07:00

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RNS Number : 7924D  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(®) 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/
(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)          +44 (0) 20 3207 7800

 Toby Flaux, Ciaran Walsh, Milo Bonser

 Jefferies (Joint Broker)                    +44 (0) 20 7029 8000

 Max Jones, Thomas Bective

 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/
(https://angleplc.com/investor-relations/glossary/)

 

Notes for editors

 

About ANGLE plc www.angleplc.com (http://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(®) system.

 

ANGLE's Parsortix(®) 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(®) 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(®) 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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