TIDMAGL
Angle PLC
02 November 2022
For immediate release 2 November 2022
ANGLE plc ("the Company")
CTCS ISOLATED BY THE PARSORTIX SYSTEM FROM METASTATIC BREAST
CANCER PATIENTS CAN BE ANALYSED BY MULTIPLE DOWNSTREAM
TECHNIQUES
Publication of results from ANGLE's multi-centre clinical study
in collaboration with leading US cancer centres
Data from the study contributed to the successful De Novo FDA
regulatory clearance of the Parsortix system
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce the publication of results from a
multi-centre clinical study undertaken with The University of Texas
MD Anderson Cancer Center, TX, Wilmot Cancer Institute, University
of Rochester, NY, Robert H Lurie Comprehensive Cancer Center,
Northwestern University, IL, and Norris Comprehensive Cancer
Center, University of Southern California, CA, US. The Parsortix(R)
system was used to enrich circulating tumour cells (CTCs) from 207
patients with metastatic breast cancer (MBC) with each patient
providing two blood tubes allowing for testing of multiple
downstream analytical techniques.
This research highlights the ability to perform multiple
downstream analyses on CTCs enriched using the Parsortix system.
CTCs isolated from the peripheral blood of MBC patients were
successfully evaluated by cytology (i.e., Wright-Giemsa staining),
real time quantitative reverse transcriptome PCR (qRT-PCR), RNA
sequencing and fluorescence in situ hybridisation (FISH). The
analyses, demonstrated to be successfully performed on CTCs
enriched by the Parsortix system, use commercially available
reagents and are standard techniques used in many clinical and/or
laboratory settings.
This successful study provided data to support the De Novo Class
II Classification application for the Parsortix system for use in
harvesting cancer cells from MBC patient blood for subsequent,
user-validated analysis, which was granted by US Food and Drug
Administration (FDA) on May 24(th) 2022.
Further details about the study
The cells captured by the Parsortix system from one of the blood
tubes were subjected to Wright-Giemsa staining and a
board-certified pathologist enumerated the CTCs by cytologic
evaluation. The second blood tube for each patient was used to
assess the proof of principle for one of three additional
evaluation techniques: gene expression analysis by qRT-PCR, RNA
sequencing, or analysis of HER2 amplification by FISH.
The cytologic evaluation identified CTCs in 48.5% of all
evaluable MBC patient samples independent of tumour subtype. CTCs
were identified in 33.3% of newly diagnosed MBC patients, and in
56.8% of recurring or progressing MBC patients. Of the MBC
patients' samples assessed by qRT-PCR, 52.7% were positive for at
least one of the CTC-related genes and showed a general correlation
with CTC count particularly at higher burden. There were 200
differentially expressed genes in the MBC patients, compared to
healthy donors, as shown through RNA sequencing, with significant
enrichment of cancer signalling pathway genes. HER2 amplification,
detected via FISH analysis, was observed in a single patient sample
with identifiable CTCs that also had HER2 positive tissue
status.
Dr. James M. Reuben, Professor, Department of Hematopathology,
Division of Pathology/Lab Medicine, MD Anderson Cancer Center and
co-PI of the trial commented:
"My lab's overarching interest is to develop assays that will
serve as companion diagnostics to assist clinicians who treat
cancer patients (MBC and non-small cell lung cancer) with therapies
such as immune checkpoint inhibitors and targeted agents.
Therefore, we have devoted considerable effort to developing
multiple cellular and molecular assays utilizing CTCs which offer a
minimally invasive approach to monitor a patient's cancer and their
response to these therapies. Data from this trial showed the
Parsortix system was able to effectively capture a single cancer
cell in a blood sample for analysis. We look forward to the further
development of CTC based assays that may bring enormous benefits to
patients with MBC as well as other cancers in the future."
Dr. Reuben receives research support from ANGLE, and he is
compensated as a member of its Scientific Advisory Board. This
financial relationship has been disclosed to MD Anderson's Conflict
of Interest Committee.
ANGLE Founder and Chief Executive, Andrew Newland, added:
"The characterisation of CTCs has the potential for clinical
utility in areas such as treatment selection, longitudinal
monitoring of treatment response and disease recurrence. We are
delighted to share the multi-centre clinical study results that
show the variety of downstream analyses possible for
characterisation of CTCs enriched by the Parsortix system. The data
from this clinical study contributed to the ground-breaking success
of a De Novo FDA regulatory clearance for the Parsortix system,
which we expect to drive the commercialisation of the system."
The research has been published as a peer-reviewed publication
in the Journal Cancers and will be 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
72 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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