TIDMAGL
RNS Number : 8707T
Angle PLC
30 March 2021
For immediate release 30 March 2021
ANGLE plc ("the Company")
GLOBAL LAUNCH OF CLINICAL SERVICES LABORATORIES
Delivering on strategy to accelerate commercialisation of the
Parsortix system and act as a demonstrator to support product
deployment
UK and US clinical laboratories now open and ready to provide
CTC analysis services and discussions with pharmaceutical industry
customers ongoing
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce that it has completed the fitout
and staffing of its clinical services laboratories in Guildford UK,
and Plymouth Meeting PA, United States. This launch comes ahead of
schedule with the US laboratory being completed sooner than
anticipated and the UK laboratory opening in line with anticipated
timescales. Together, these laboratories will allow ANGLE to
accelerate the commercial deployment of the Parsortix(R) system by
offering services to pharmaceutical and biotech customers for use
in cancer drug clinical trials and, once the laboratories are
accredited and tests validated, through the provision of Laboratory
Developed Tests (LDTs) for patient care.
ANGLE's sample to answer liquid biopsy solution via a simple
blood test enables longitudinal monitoring of patients during drug
trials (before, during and after drug intervention) which is not
possible with tissue biopsy. This represents a significant market
opportunity for ANGLE. In a single subset of this market, there are
over 2,000 PD-L1/PD-1 interventional trials registered on
clinicaltrials.gov, enrolling over 300,000 patients, which would be
potential targets for ANGLE's pharma services business.
ANGLE is targeting future clinical studies for adoption of the
Parsortix system and has developed service capabilities in the
United Kingdom and the United States to process samples on a
commercial scale as part of global pharma trials. ANGLE has already
established dialogue with prospective customers and collaborators
for the deployment of CTC liquid biopsy analysis in cancer drug
trials, with a number of these conversations at an advanced
stage.
Both the UK and US laboratories will seek ISO15189 accreditation
and the US laboratory will also seek Clinical Laboratory
Improvement Amendments (CLIA) accreditation, which will allow them
to market LDTs for clinical use. Given the extensive clinical work
already completed with the Ovarian Cancer Pelvic Mass Triage assay,
it is anticipated that this will be ANGLE's first LDT to
market.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"The new clinical services laboratories are an important element
in the Company's commercial strategy and we are pleased to launch
the global offering ahead of schedule. This will accelerate
commercialisation of the Parsortix system and act as a demonstrator
to support product deployment. As well as working with
pharmaceutical company customers directly, we are keen to work with
contract research organisations both as a white label service and,
when they wish to deploy the tests internally, by supplying
Parsortix systems so that they can directly offer their own CTC
services for cancer drug trials. This will enable us to scale the
commercial use of the Parsortix system in this large market. We are
in advanced discussions with potential customers and we look
forward to updating the market on the first contracts in due
course."
For further information ANGLE:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Andrew Holder, Head of Investor Relations
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance - Carl Holmes, Simon
Hicks, Teddy Whiley
ECM - Alice Lane, Sunila de Silva +44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks, Andrew Craig,
Chris Lee +44 (0) 203 705 9330
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
The information communicated in this announcement is inside
information for the purposes of Article 7 of Regulation
596/2015.
For Frequently Used Terms, please see the Company's website on
https://angleplc.com/investor-relations/glossary/
Notes for editors
About ANGLE plc 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 and a downstream analysis system for cost effective,
highly multiplexed analysis of nucleic acids and proteins.
ANGLE's cell separation technology is called the Parsortix(R)
system, and it enables a liquid biopsy (a simple blood test) to be
used to provide the cells of interest 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 types of CTCs as well as
CTC clusters in a viable form (alive). CTCs enable the complete
picture of a cancer to be seen as being an intact cell they allow
DNA, RNA and protein analysis and thus provide comparable analysis
to a tissue biopsy. 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. In addition, the live CTCs harvested can be cultured, which
offers the potential for testing 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.
The Parsortix system has a CE Mark in Europe for the indicated
use and, in the United States, a De Novo Submission has been made
to FDA for the Parsortix(R) PC1 system seeking FDA clearance with
Class II Classification for use with metastatic breast cancer
patients. FDA clearance is seen as the global standard. ANGLE is
seeking to be the first ever FDA cleared system for harvesting CTCs
for subsequent analysis.
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 is currently in
the process of a 200 patient clinical verification study.
ANGLE's technology for the multiplex evaluation of proteins and
nucleic acids of all types is called the HyCEAD(TM) Ziplex(R)
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 Ziplex 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
41 peer-reviewed publications and numerous publicly available
posters, available on our website.
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
MSCBRGDXCGDDGBC
(END) Dow Jones Newswires
March 30, 2021 02:00 ET (06:00 GMT)
Angle (LSE:AGL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Angle (LSE:AGL)
Historical Stock Chart
From Apr 2023 to Apr 2024