REG - Angle PLC - Pharma services contract with Artios Pharma

AngleAnnouncement

25/05/2023 07:00

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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 indicate 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)          +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 Artios www.artios.com (http://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 Polθ 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 (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 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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