TIDMAGL
RNS Number : 6664W
Angle PLC
19 April 2023
For immediate release 19 April 2023
ANGLE plc ("the Company")
HER2 ASSAY DEVELOPMENT PARTNERSHIP WITH BIOVIEW
Agreement with BioView to develop a CTC-based HER2 assay
First phase expected to generate c. GBP1.2 million revenue
ANGLE plc (AIM: AGL; OTCQX: ANPCY), a world-leading liquid
biopsy company, is delighted to announce it has signed an agreement
with BioView Ltd. ("BioView") (BIOV.TA) to develop a liquid biopsy
circulating tumor cell (CTC) HER2 assay for breast cancer utilising
ANGLE's FDA cleared Parsortix(R) PC1 Clinical System to harvest
CTCs and BioView's automated microscopy systems and software to
detect and assess the HER2 expression and/or gene amplification in
CTCs.
BioView develops, manufactures and markets innovative automated
cell imaging and analysis solutions and has received FDA product
clearance for its fluorescent in situ hybridisation (FISH)
application for HER2 analysis of FFPE breast tissue sections,
hybridised with Abbott's PathVysion HER2 DNA probe kit (see
https://bioview.com/applications/pathology/breast/ ). ANGLE has
already successfully integrated BioView's technology in its R&D
and clinical laboratories for assay development and pharma
services.
ANGLE and BioView will now begin the programme of developing a
HER2 assay for the detection of HER2 protein via immunofluorescence
(IF) and HER2/neu gene amplification by FISH, utilising Abbott's
PathVysion HER2 DNA probe kit, in CTCs from breast cancer patients'
blood samples harvested using ANGLE's FDA cleared Parsortix PC1
Clinical System and analysed using BioView's automated imaging and
analysis technology.
It is recognised that breast cancer can be highly heterogeneous
and that HER2 status can change over time. In addition, results
from a recent high impact study have revealed that patients
categorised with HER2-low breast cancer (and defined as
immunohistochemistry (IHC) score 1+ and 2+ and HER2-negative by
FISH), can in fact, benefit from new HER2 targeted antibody-drug
conjugates, where typical HER2 targeted drugs have previously been
reserved for HER2-positive (HER2 IHC 3+ and/or HER2 FISH positive)
breast cancer patients. This new understanding is driving the
adoption of HER2-low targeted drugs such as ENHERTU(R) marketed by
Daiichi-Sankyo and AstraZeneca.
This changing market dynamic has provided ANGLE and BioView with
a major commercial opportunity to develop a quantitative CTC-based
HER2 assay, to assess HER2 protein expression and/or gene
amplification levels by analysing fluorescence intensities. This
would be the only product-based solution on the market for this
purpose leveraging both companies' previous FDA product clearances.
Unlike current standard of care tests developed for use on FFPE
tissue, a CTC HER2 assay could be used for longitudinal monitoring
of HER2 status throughout disease progression, thereby ensuring the
patient is targeted for the most appropriate treatment at every
stage. The development phase is estimated to take around a year to
complete with the assay development work generating c. GBP1.2
million of revenues for ANGLE.
HER2-low breast cancer accounts for 55% of all breast cancer
cases whereas HER2-positive cancer accounts for 25% of cases. The
new use of trastuzumab deruxtecan (ENHERTU(R) ) to include HER2-low
patients has resulted in analysts predicting up to a US$3 billion
annual increase in sales value. Because of market expansion into
HER2-low patients, and the need for novel biomarkers enabling
ongoing patient monitoring of HER2 status, ANGLE and BioView
believe there will be demand from medtech and pharma companies for
quantitative CTC-based HER2 detection assays to enable regular and
accurate stratification of patient populations.
Given the significant third-party interest in a new assay for
quantitative HER2 analysis based on CTCs, ANGLE and BioView have
agreed to allow for the inclusion of third parties in this project
and its funding as we move into the commercialisation stage after
the initial development work is complete. The parties are
continuing to discuss strategic routes to market with potential
corporate partners.
BioView President and CEO, Dr. Alan Schwebel, commented:
"We are excited for this development partnership opportunity
with ANGLE, where we plan to leverage the strengths of both our
technologies to develop an impactful liquid biopsy HER2 CTC test.
CTCs present a unique opportunity to access protein and/or genomic
alterations of HER2 throughout the patient's cancer treatment to
help ensure eligibility for the right therapy to improve patient
outcomes."
ANGLE Founder and Chief Executive, Andrew Newland, added:
"We are delighted to have entered into this partnership with
BioView utilising our established bespoke assay development
capability. The changing breast cancer treatment landscape has
created a major commercial opportunity for a CTC-based HER2 assay
allowing repeat testing and longitudinal monitoring of patients to
personalise cancer care. We believe this new 'content' will drive
wide adoption of the Parsortix system in the treatment of breast
cancer."
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)
Thomas Bective, Shaam Vora +44 (0) 20 7029 8000
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the EU Market Abuse Regulation (596/2014) . Upon the publication of
this announcement via a regulatory information service, this
information is considered to be in the public domain.
For Frequently Used Terms, please see the Company's website on
https://angleplc.com/investor-relations/glossary/
Notes for editors
About BioView www.bioview.com
BioView develops, manufactures and markets innovative automated
microscopy imaging and analysis solutions that applies machine
learning algorithms to automatically detect and classify target
cells. Operating since 2000, BioView is headquartered in Israel and
has a fully owned subsidiary in the Unites States, which is
responsible for sales and support in America. Products are also
internationally distributed by Abbott Molecular.
Founded and managed by physicists and software experts, BioView
leverages its knowledge and extensive expertise in the areas of
medical devices combined with clinical and research applications,
in creating its breakthrough imaging and analysis solutions. The
suite of instruments and software have been adopted for use in
cytology, cytogenetic, pathology clinical and research laboratories
across the world. BioView has remained focused on oncology
molecular diagnostic testing solutions and has received US FDA 510K
clearance for five FISH tests and regulatory approvals in China,
Korea, Australia and European Union CE mark as the imaging and
analysis solution. Over the years BioView has applied their
expertise in detection and classification of cells that are low in
abundance to detection of the CTCs to enable their use in a liquid
biopsy.
Lead by senior executives with vast accumulated experience in
both the development and successful marketing of solutions such as
diagnostic equipment with vision applications, BioView remains one
step ahead of the game with assay-specific applications ready for
use even before the tests reach the market.
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
77 peer-reviewed publications and numerous publicly available
posters from 35 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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCEAELPFFADEAA
(END) Dow Jones Newswires
April 19, 2023 02:00 ET (06:00 GMT)
Angle (LSE:AGL)
Historical Stock Chart
From Jun 2024 to Jul 2024
Angle (LSE:AGL)
Historical Stock Chart
From Jul 2023 to Jul 2024