REG - Angle PLC - ANGLE announces partnership with BioView

AngleAnnouncement

19/04/2023 07:00

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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. £1.2 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(®) 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/
(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(®) 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. £1.2 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(®)) 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)          +44 (0) 20 3207 7800

 Toby Flaux, Ciaran Walsh, Milo Bonser

 Jefferies (Joint Broker)                    +44 (0) 20 7029 8000

 Thomas Bective, Shaam Vora

 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/
(https://angleplc.com/investor-relations/glossary/)

 

Notes for editors

 

About BioView www.bioview.com (http://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 (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 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.

 

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