RCS - Angle PLC - ANGLE Parsortix poster presented at AACR 2023

AngleAnnouncement

17/04/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230417:nRSQ3454Wa&default-theme=true

RNS Number : 3454W  Angle PLC  17 April 2023

 For immediate release  17 April 2023

 

ANGLE plc ("the Company")

 

PARSORTIX POSTER PRESENTED AT AACR ANNUAL MEETING 2023

 

Study demonstrates the feasibility of combining IF and HER2 FISH analysis with
CTCs harvested using the Parsortix system

 

Capability to measure HER2 protein overexpression on CTCs using ANGLE's
Portrait Flex assay opens up substantial pharma and clinical market
opportunities

 

 

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is
pleased to announce the presentation of a poster at the American Association
for Cancer Research (AACR) annual meeting, in Orlando, Florida, United States,
between 14-19 April 2023. The poster presents successful development work
undertaken by ANGLE since FDA clearance to develop protocols to combine
immunofluorescent (IF) staining for epithelial, mesenchymal and
epithelial-to-mesenchymal (EMT) phenotype characterisation of circulating
tumour cells (CTCs) with HER2 fluorescence in-situ hybridization (FISH)
staining for gene amplification assessment on samples from blood processed
using the Parsortix(®) system.

 

Additionally, the study demonstrated the successful isolation of CTCs from the
blood of metastatic breast cancer (MBC) patients using the Parsortix system,
followed by subsequent detection of HER2 protein expression alongside the
epithelial, mesenchymal and EMT phenotype characterisation using the ANGLE
developed Portrait Flex IF assay.

 

The analytical sensitivity and specificity (using spiked samples from healthy
volunteers) of ANGLE's Portrait Flex assay for HER2 protein expression
detection were both greater than 90%. The percentage recovery of cancer cells
following combined IF and FISH staining was comparable to that achieved with
the HER2 FISH assay alone, showing that the two downstream analysis methods
can be combined to maximise relevant information on HER2 expression.

 

In addition, blood samples from 16 MBC patients were processed using the
Parsortix system and analysed using the Portrait Flex assay, with the
inclusion of the HER2 antibody for protein detection. CTCs were identified in
81% (13/16) of the patients, with 38.5% (5/13) of the CTC-positive patients
having ≥ 1 CTC with high levels of HER2 protein expression. Furthermore, of
the CTC-positive patients, 77% (10/13) had ≥1 CTC cluster (ranging from 2 to
110 CTCs per cluster, and 1 to 29 clusters per patient). This may be
significant as previous research has indicated that CTC clusters are
associated with increased metastatic potential. The presence or absence and
the level of expression of HER2 for a patient at a given timepoint is key to
treatment decision-making in breast cancer.

 

The research presented at the AACR annual meeting highlights the successful
use of the Parsortix system and analysis on HER2 expression using ANGLE's
Portrait Flex IF assay combined with a commercially available HER2 FISH assay.
Moreover, HER2 protein expression was successfully detected alongside
epithelial, mesenchymal and EMT characterisation in CTCs harvested from the
blood of MBC patients processed on the Parsortix system.

 

It is known that breast cancer can be highly heterogeneous and that HER2
status can change over time. In addition, results from a recent 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.

 

These developments provide a commercial opportunity for a CTC-based HER2
assay, to assess HER2 gene expression and/or protein expression levels by
analysing fluorescence intensities.  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, meeting
an unmet medical need and potentially significantly expanding the size of the
HER2 diagnostic market.

 

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are pleased to announce ANGLE's attendance and contribution at the AACR
annual meeting this year. The poster presented showcases the utility of the
Parsortix system for the harvest of CTCs and analysis using a combined IF and
FISH approach. We also demonstrate successful characterisation and detection
of HER2 protein overexpression using an ANGLE developed assay in CTCs isolated
from MBC patients, showing the potential for use of this assay in improving
patient stratification. Given the changing dynamics of the HER2 market in
response to the introduction of new drugs targeting low HER2 expression, we
believe the proof of concept achieved with this assay has significant
commercial relevance.  Development of the Portrait Flex IF assay is part of
ANGLE's programme to develop 'content' for Parsortix in the form of downstream
applications using the Parsortix harvested cancer cells."

 

The research 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

 Thomas Bective, Shaam Vora

 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 77
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.

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word “Reach” in the source column of the News Explorer pages of London Stock Exchange’s website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.

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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRABQLLFXZLZBBQ