TIDMAGL
RNS Number : 0410W
Angle PLC
13 April 2023
For immediate release 13 April 2023
ANGLE plc ("the Company")
Pharma Services Contract with Crescendo Biologics
Crescendo to use ANGLE's recently launched Portrait Flex Assay
in prostate cancer study
ANGLE plc (AIM: AGL; OTCQX: ANPCY), a world-leading liquid
biopsy company, is delighted to announce that it has signed a
contract with a new customer, Crescendo Biologics Limited
("Crescendo"). Crescendo is a UK-based, clinical stage
immuno-oncology company with an extensive proprietary pipeline of
novel, targeted T cell enhancing Humabody(R) therapeutics .
Crescendo will use ANGLE's recently launched Portrait Flex assay in
its ongoing Phase 1 clinical trial ( NCT04839991 ) investigating
the safety and efficacy of CB307, Crescendo's first-in-class
prostate-specific membrane antigen (PSMA) x CD137 half-life
extended bispecific, for the treatment of patients with PSMA
positive solid tumours.
ANGLE developed the immunofluorescence (IF) Portrait Flex assay
for the detection of epithelial and mesenchymal circulating tumour
cells (CTCs) as well as those undergoing the epithelial-mesenchymal
transition (EMTing). Additionally, the assay offers the customer
the possibility of adding any bespoke protein biomarker, depending
on its needs. The assay has high sensitivity and specificity
(>90%) for epithelial and mesenchymal CTCs, which are known to
be involved in cancer metastasis and drug resistance and was
launched in late 2022 as an offering to pharma services
customers.
Crescendo will use the Portrait Flex assay in the cohort
expansion part of its ongoing clinical study, sending patient
samples to ANGLE's ISO15189 accredited clinical laboratories for
processing using the Parsortix system and analysis.
Crescendo Biologics' VP, Translational Biology, Dr Andrew
Pierce, commented:
"We are excited to be working with ANGLE to provide an important
element of our robust translational package as we seek to further
illustrate the mechanism by which CB307 can bring clinical benefit
to patients."
ANGLE Founder and Chief Executive, Andrew Newland, added:
"The use of CTC biomarkers in clinical trials is a rapidly
growing field, facilitating the identification of druggable targets
as well as providing prognostic information, predicting treatment
response, resistance, and patient relapse. We are delighted that
Crescendo Biologics has adopted our new Portrait Flex assay and we
will seek opportunities to expand our relationship going forward.
Our menu of Parsortix based CTC assays is building and the pipeline
of potential pharma services customers is growing as a result."
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 Crescendo Biologics
Crescendo Biologics is a private, clinical stage immuno-oncology
company developing novel, targeted T cell enhancing Humabody(R)
therapeutics.
Leading its proprietary pipeline, Crescendo Biologics has
developed CB307, a novel half-life extended CD137 x PSMA Humabody
for the selective activation of tumour-specific T cells exclusively
within the tumour microenvironment. CB307 is designed to achieve a
longer lasting anti-cancer effect whilst avoiding systemic
toxicity, and the clinical programme for CB307 is underway in
patients with PSMA positive solid tumours ( NCT04839991 ). CB693 is
a half-life extended CD137 x MSLN Humabody and is the second
proprietary clinical candidate from Crescendo's T cell enhancing
pipeline. Crescendo is also developing CB213, a preclinical PD-1 x
LAG-3 multi-specific Humabody.
The Company's ability to develop multi-functional Humabody
therapeutics is based on its unique, patent protected, transgenic
mouse platform generating fully human VH domain building blocks
(Humabody VH). These robust molecules can be configured to engage
therapeutic targets in such a way that they deliver novel
pharmacology and superior bio-distribution. This can lead to larger
therapeutic windows compared to conventional IgG approaches.
Humabody-based formats can also be applied across a range of
non-cancer indications.
Beyond Crescendo's proprietary pipeline, the Company has global,
multi-target discovery and development collaborations with both
Takeda and BioNTech and an exclusive, worldwide licensing agreement
with Zai Lab for ZL-1102 (formerly CB001, an anti-IL-17A targeting
Humabody), which is expected to enter global Phase 2 clinical
development in patients with psoriasis.
Crescendo Biologics is located in Cambridge, UK, and is backed
by blue-chip investors including Sofinnova Partners, Andera
Partners, IP Group, BioNTech, Takeda and Quan Capital.
For more information, please visit www.crescendobiologics.com
and follow @HUMABODY .
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
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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