TIDMAGL
RNS Number : 5786A
Angle PLC
25 May 2023
For immediate release 25 May 2023
ANGLE plc ("the Company")
Pharma Services Contract Win
Parsortix DNA Damage Response Assays developed by ANGLE to be
used for exploratory objectives in a Phase 1 clinical trial
Trial expected to complete by year end 2024
ANGLE plc (AIM: AGL; OTCQX: ANPCY), a world-leading liquid
biopsy company, is delighted to announce that its first bespoke
assay development customer, Artios Pharma (Artios), has signed a
new contract to utilise two DNA Damage Response assays developed by
ANGLE in a Phase 1 clinical trial expected to commence shortly.
Artios is a clinical-stage biotech company pioneering the
development of small molecule therapeutics that target the DNA
Damage Response (DDR) process in order to treat patients with a
broad range of cancers. Artios has an extensive DDR focused
pipeline and strategic partnerships with global pharma
companies.
Artios selected ANGLE to develop immunofluorescence (IF) assays
using its Parsortix system to detect two specific biomarkers
expressed on circulating tumour cells (CTCs). The expression of the
two biomarkers i ndicate the amount of DNA damage caused in a
cell.
The markers can be observed in tumour tissue, but the
availability of tumour tissue biopsy material is limited and cannot
be repeated, emphasising the utility of CTCs obtained via liquid
biopsy as an alternative means of assessing DNA damage. Artios is
utilising longitudinal monitoring of expression of these biomarkers
in CTCs harvested using the Parsortix system to assess the
pharmacodynamic effects and treatment response to new DDR
drugs.
The successful development of these DDR assays (high levels of
both sensitivity and specificity were achieved) was technically
challenging and a significant achievement. Artios will now utilise
the two assays in a Phase 1 clinical trial scheduled to begin
shortly and expected to complete around the end of 2024. ANGLE
anticipates that these assays could be employed in larger, later
stage clinical trials for the same compound and potentially in
further trials for additional compounds in the customer's
pipeline.
ANGLE can offer this CTC solution to the growing number of drug
developers exploring the DDR pathway in drug trials. There are an
estimated 105 drugs targeting the DDR pathway in development, with
123,000 patients currently enrolled in active clinical trials
(clinicaltrials.gov). In 2020 the global value of DDR therapeutics
was US$3.5 billion and is expected to grow to US$ 24.8bn by 2030
with a CAGR of 21.3%.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"We are delighted to have successfully developed these
high-performance assays for Artios, a leader in the fast-growing
field of DDR therapeutics. This new contract for clinical trial
services again represents significant repeat business from an
existing customer and we believe there is potential to expand the
relationship further. These new assays also provide an important
addition to our pharma services menu where our unique solution has
already generated a high level of interest from new potential
customers."
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 Artios www.artios.com
Artios is on a mission to kill cancer by exploiting DNA damage
repair (DDR) responses that are leveraged by cancer cells to
promote their survival. Our specialized DcoDeR platform integrates
Artios' leadership capabilities, expertise and experience in DNA
damage biology and drug discovery to systematically discover and
develop medicines targeting the totality of the DDR. We have built
an extensive DDR focused pipeline designed to address areas of high
unmet needs across solid tumour indications including our ATR
inhibitor, ART0380, and our Pol inhibitor, ART4215, as a
monotherapy and with combination treatments. Together with our
world-class strategic partnerships with Merck KGaA and Novartis,
and research collaborations with premiere institutions like Cancer
Research UK, The Institute of Cancer Research, The Netherlands
Cancer Institute, and the Crick Institute we are pioneering
validated approaches to DDR drug discovery.
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
79 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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