TIDMAGL
Angle PLC
12 December 2022
For immediate release 12 December 2022
ANGLE plc ("the Company")
TWO PARSORTIX POSTERS PRESENTED AT LEADING BREAST CANCER
CONFERENCE
Studies demonstrate the utility of the Parsortix PC1 Clinical
System to isolate and harvest CTCs from metastatic breast cancer
patients for further downstream analysis
Harvested CTCs underwent cytological, immunofluorescent and
molecular downstream evaluation
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce the presentation of two posters at
the San Antonio Breast Cancer Symposium (SABCS), in San Antonio,
Texas, United States, between 06-10 December 2022. The studies
demonstrated the successful isolation and subsequent analysis of
circulating tumour cells (CTCs) from Metastatic Breast Cancer (MBC)
patient blood samples using the Parsortix(R) PC1 Clinical
System.
The first poster, presented by ANGLE, outlines the utility of
the Parsortix PC1 Clinical System in capturing and harvesting CTCs
from a significantly larger proportion of MBC patients, compared to
healthy donor samples. The ANG-008 study evaluated 75 MBC patient
blood samples and 71 healthy volunteer blood samples. Firstly, the
harvested CTCs were deposited onto glass slides for staining using
cytocentrifugation, a method which has been shown to lose a
significant proportion of cells. The cells retained on the cytology
slides were stained using an immunofluorescence (IF) assay, and
CTCs were characterized as nucleated cells that were positive for
CK and/or EpCAM and negative for blood markers. The IF-stained
slides were subsequently restained using Wright-Giemsa reagents and
CTCs identified by a qualified pathologist. CTCs were observed in
45.3% and 42.9% of MBC patients following IF and Wright-Giemsa
evaluation, respectively. Of the CTC-positive MBC patient samples,
70.6% had CK positive and EpCAM negative cells only. This high
proportion of EpCAM negativity highlights the limitations of using
EpCAM-based approaches to capture CTCs and the advantages of using
the epitope-independent Parsortix PC1 Clinical System.
The second poster, presented by The University of Texas MD
Anderson Cancer Center, showed results from the ANG-002 HOMING
study, a prospective clinical trial that highlights the use of the
Parsortix PC1 Clinical System for the isolation and harvest of CTCs
from patients with MBC and its ability to perform multiple
subsequent downstream analyses on the harvested CTCs. The research
evaluated 207 MBC patients, including newly diagnosed, recurrent
and progressive MBC patients, and 204 healthy volunteers.
Similarly, this study identified CTCs using Wright-Giemsa staining
confirmed by a qualified pathologist. Furthermore, as proof of
concept, CTCs harvested from a second blood sample were evaluated
using one of three additional subsequent evaluation techniques,
including molecular profiling by real time quantitative reverse
transcription PCR (qRT-PCR) or RNA sequencing, or analysis of HER2
amplification by fluorescence in situ hybridisation (FISH).
The cytologic evaluation, which used the same cytocentrifugation
method to deposit the harvested cells onto glass slides for
staining, identified CTCs in 48.5% of all evaluable MBC patient
sample independent of tumour subtype. Molecular profiling
demonstrated (i) a higher expression of CTC related genes in MBC
patients compared to healthy volunteers, (ii) a correlation of CTC
related gene expression with CTC count and (iii) genes from a
specific cancer pathway (KEGG) were differentially expressed in MBC
patients when compared to healthy volunteers. Furthermore, the HER2
status, analysed by FISH, of the harvested CTCs was successfully
evaluated, with amplification being observed in a single CTC from
an MBC patient sample.
Data generated from both studies was used to support the De Novo
classification of the Parsortix PC1 Clinical System as a Class II
device, which was granted by the US Food and Drug Administration
(FDA) on 24(th) May 2022.
Overall, the research presented at the SABCS highlights the
successful use of the Parsortix PC1 Clinical System for CTC
enrichment in blood from patients with MBC, allowing for a variety
of possible downstream analyses, including IF and Wright-Giemsa
staining and molecular profiling evaluation.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"We are pleased to announce ANGLE's contributions and attendance
at the San Antonio Breast Cancer Symposium this year. The two
posters presented showcase the utility of the Parsortix PC1
Clinical System for the isolation and harvest of CTCs for use in
multiple subsequent downstream analyses. We continue to show the
valuable use of the instrument to identify EpCAM negative CTCs,
which is not possible with alternative antibody-based approaches.
The data from these two studies contributed to the ground-breaking
success of a De Novo FDA regulatory clearance for the Parsortix PC1
Clinical System, which we believe will drive future commercial
success."
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
75 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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