RCS - Angle PLC - Study using Parsortix in head and neck cancer

AngleAnnouncement

28/09/2022 07:00

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RNS Number : 9087A  Angle PLC  28 September 2022

 For immediate release  28 September 2022

 

ANGLE plc ("the Company")

 

STUDY USING PARSORTIX DEMONSTRATES IMPORTANCE OF BIOMARKER-INDEPENDENT CTC
ISOLATION IN HEAD AND NECK CANCER

 

EMT status of CTCs found to provide additional insight to tumour tissue biopsy

 

Potential role of CTC EMT biomarkers as therapeutic targets

 

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is
pleased to announce that the University of Birmingham has published the
results of a study undertaken in head and neck squamous cell carcinoma (HNSCC)
which characterised the epithelial-mesenchymal transition (EMT) status of
circulating tumour cells (CTCs). EMT is clinically significant due to its role
in tumour progression and invasion, the development of metastasis, metabolic
reprogramming, immune evasion, and resistance of cancer cells to therapy.

 

The study used the Parsortix(®) system to harvest CTCs from peripheral blood
samples from 20 treatment-naïve HNSCC patients at baseline prior to surgery.
The researchers performed flow-cytometry EMT characterisation of CTCs as
compared to EMT gene expression in tumour tissue and investigated expression
correlation with respect to clinical outcomes. The expression of EpCAM and
N-cadherin were utilised to characterise CTC status as epithelial or EMT. CTCs
were detected in 65% of patients and 77% of positive samples included CTCs
undergoing EMT.

 

The research demonstrated that EMT status of CTCs was almost exclusively
associated with advanced stage (III-IV) disease. In this small patient cohort
CTC enumeration alone was not reported to be prognostic with respect to
overall survival and progression free survival. However, CTC EMT status was
found to be independent to that of tumour tissue, highlighting the potential
clinical utility of CTC EMT biomarkers as a complementary analyte to tumour
tissue biopsy or as therapeutic targets.

 

Head and Neck Cancer (HNC) is a broad term used to group oral cavity, pharynx,
larynx, salivary gland and nose and sinus cancer, with 90-95% of HNCs being
squamous cell cancers. Globally, HNC accounted for over 930,000 new cases and
over 460,000 deaths in 2020. In head and neck squamous cell carcinoma, 5-year
survival rates are in the region of 50%, depending on cancer type and stage,
but largely static for several decades. Common risk factors of this cancer
include gender, ethnicity, age, poor oral hygiene, tobacco and alcohol use.
The toxicity associated with current treatment regimens for this cancer
results in a significant impact upon quality of life. Therefore, early
diagnosis and effective targeted treatment options are urgently required to
improve patient outcomes. A liquid biopsy, in particular analysing CTCs, is
one potential avenue to define such therapeutic biomarkers.

 

Professor Hisham Mehanna, the Chair of Head and Neck Surgery, and Director of
the Institute of Head and Neck Studies and Education (InHANSE) at the
Institute of Cancer and Genomic Sciences, University of Birmingham, commented:

"The successful characterisation of EMT CTCs in HNSCC sheds light on the
potential adaptive EMT response to stimuli within the circulation of blood,
providing an important and unique insight into metastasis. Prospective
clinical trials are needed to answer the question regarding the predictive
utility of a CTC liquid biopsy (for example CTC immune checkpoint expression
directing personalised treatment), especially in recurrent/metastatic patients
not amenable to repeat tissue biopsies."

 

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"ANGLE is pleased to report on the use of the Parsortix system as a tool for
HNSCC EMT classification. Evidence continues to grow supporting the potential
clinical utility of CTC enrichment to provide clinical information beyond the
scope of tissue biopsy. This research provides further evidence for the role
that EMT CTCs play in the metastatic cascade and the clinical importance of
biomarker independent CTC isolation methods which capture all subsets of CTCs.
In drug discovery, this may enable the identification of drugs that are better
able to target cancer cells known to be the precursors of metastasis. As
metastasis is responsible for 90% of cancer deaths, this could be
transformative for cancer care and patient outlook."

 

The research has been published as a peer-reviewed publication in the Journal
Head and Neck and 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 platforms include a circulating
tumor cell (CTC) harvesting technology known as the Parsortix(®) system and a
downstream analysis system for cost effective, highly multiplexed analysis of
nucleic acids and proteins.

 

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 two separate 200 subject clinical studies under a
program designed to develop an ovarian cancer pelvic mass triage test, with
the results showing best in class accuracy (AUC-ROC) of 95.1%. The pelvic mass
triage assay has undergone further refinement and optimisation and a 200
patient clinical verification study has now completed enrolment.

 

ANGLE's technology for the multiplex evaluation of proteins and nucleic acids
of all types is called the HyCEAD(TM) platform and is based on a patented flow
through array technology. It provides for low cost, highly multiplexed, rapid
and sensitive capture of targets from a wide variety of sample types. A
proprietary chemistry approach (the HyCEAD method) allows for the capture and
amplification of over 100 biomarkers simultaneously in a single reaction. The
HyCEAD system is extremely sensitive and is ideal for measuring gene
expression and other markers directly from Parsortix harvests and was used in
the ovarian cancer pelvic mass triage test to achieve best in class accuracy
(AUC-ROC) of 95.1%.

 

ANGLE's proprietary technologies can be combined to provide automated,
sample-to-answer results in both centralised laboratory and point-of-use
cartridge formats.

 

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 69
peer-reviewed publications and numerous publicly available posters from 31
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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