REG - Angle PLC - Pharma Services Contract with Crescendo Biologics

AngleAnnouncement

13/04/2023 07:00

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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(®) therapeutics. Crescendo will use
ANGLE's recently launched Portrait Flex assay in its ongoing Phase 1 clinical
trial (NCT04839991 (https://clinicaltrials.gov/ct2/show/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)          +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 Crescendo Biologics

Crescendo Biologics is a private, clinical stage immuno-oncology company
developing novel, targeted T cell enhancing Humabody(®) 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
(https://clinicaltrials.gov/ct2/show/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
(http://www.crescendobiologics.com) and follow @HUMABODY
(https://twitter.com/HUMABODY) .

 

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 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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