RCS - Angle PLC - Multiple downstream analysis techniques for CTCs

AngleAnnouncement

02/11/2022 07:17

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RNS Number : 9856E  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(®) 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/
(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 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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