REG - Angle PLC - Partnership with major United States urology group

AngleAnnouncement

30/05/2022 07:15

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RNS Number : 1584N  Angle PLC  30 May 2022

 

 For immediate release  30 May 2022

 

ANGLE plc ("the Company")

 

PARTNERSHIP ESTABLISHED WITH A MAJOR UNITED STATES UROLOGY GROUP TO CONDUCT
CLINICAL STUDIES IN PROSTATE CANCER AND AS A POTENTIAL ROUTE TO MARKET

 

MidLantic Urology to evaluate the Parsortix system in prostate cancer clinical
studies and enable potential sales to Solaris Health extensive patient base

 

Major unmet medical need for a pre-screening tool ahead of invasive prostate
tissue biopsy as an aid to assessing prostate cancer presence and
aggressiveness to guide treatment choices

 

 

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is
delighted to announce it has signed a master clinical study agreement with
Solaris Health Holdings, LLC (Solaris) and joinder agreements with MidLantic
Urology LLC, to collaborate and conduct clinical studies in prostate cancer
and as a potential route to market in the United States.

 

MidLantic Urology, an affiliate of Solaris, is one of the largest providers of
specialist urology services in the United States with more than 70 physicians
operating from 47 dedicated urology centres across the state of Pennsylvania.
The Solaris Health network encompasses more than 500 clinical urology
providers across 179 locations and nine States with more than 729,000 unique
patients annually.

 

Together with MidLantic Urology, ANGLE will initiate clinical studies aimed at
investigating the use of the Parsortix(®) system for the detection of
prostate cancer and prediction of its severity in patients who present with an
elevated prostate specific antigen (PSA) level and/or abnormal digital rectal
exam.

 

The design of the first study to be conducted with MidLantic Urology, expected
to be initiated in Q3 2022, has been informed by earlier pilot studies
independently conducted at the Barts Cancer Institute (Queen Mary University
London) which used the Parsortix system to harvest circulating tumour cells
(CTCs).  This study will initially enrol 100 men scheduled to undergo a
prostate tissue biopsy at a minimum of three study sites over an anticipated
period of up to nine months.  Blood samples collected by MidLantic Urology
will be shipped to ANGLE's United States clinical laboratory for processing by
the Parsortix system to harvest and analyse CTCs and associated immune cells.
 The Parsortix harvests will be evaluated by both imaging and molecular
analysis to assess the potential to predict the presence of clinically
significant prostate cancer prior to tissue biopsy and to assess potential
correlation with established disease severity scores (e.g. the Gleason score)
in those patients found to have prostate cancer.

 

ANGLE expects headline results from the first study of 100 men in 2023.
Compelling data could form the basis of a laboratory developed test which
ANGLE would offer from its clinical laboratories in the United States and the
UK.  Solaris could be ANGLE's first route to market for this test, offering
the established test to their extensive patient base.  Successful results
could also allow the design of a larger validation study to support an
eventual submission to FDA and other regulatory bodies for this application.

 

Prostate cancer is the leading cause of cancer in men and accounts for 13% of
all new cancer cases in the United States. Under the national screening
programme, 11 million men will undergo a PSA test in the US each year. Of
these, some 1.2 million will have an abnormal result, leading to further
investigations. The current standard of care, transrectal or transperitoneal
prostate tissue biopsy, is an invasive procedure associated with significant
clinical complications and cost. Following the procedure, 32% of patients are
reported to experience moderate side effects, with 1.4% of patients
experiencing major complications. This includes post-biopsy sepsis in 2-5% of
cases with up to 25% requiring admission to ICU at an estimated cost of
US$19,000 per patient. Prostate tissue biopsies are negative in 75% of
patients and therefore place patients at unnecessary risk but may also miss
the cancer in 30-40% of cases, requiring patients to undergo repeat tissue
biopsy. At least 60% of prostate cancers diagnosed are indolent and unlikely
to cause harm during a patient's lifetime. Nonetheless many men will undergo
radical prostatectomy which is associated with significant post-procedure
complications including urinary incontinence and erectile dysfunction. Liquid
biopsy offers the potential for a much safer, cost-effective diagnosis, active
surveillance where appropriate and, following diagnosis, the ability to offer
longitudinal monitoring and up to date targeted treatment selection.

 

 

Dr Jose Moreno, Principal Investigator, MidLantic Urology, commented:

"Even though PSA is a valuable marker of response to prostate cancer
treatment, its role in screening is modest at best and can lead to both
overdiagnosis of clinically indolent prostate cancer and underdiagnosis of
clinically significant prostate cancer which can result in increased rates of
local failure and metastatic disease.

 

ANGLE's Parsortix platform has the potential to enable molecular
characterisation of the cancer using a blood test in patients undergoing both
traditional ultrasound biopsies and MRI fusion biopsies.  The preliminary
data suggest that we may be able to create an assay for the detection of
clinically significant prostate cancer that has high specificity and
sensitivity. Moreover, the assay can be customized to operate in a wide
spectrum of prostate cancer disease states, including pre-prostate biopsy,
after a negative biopsy, active surveillance, after local failure, and in
early and late metastatic disease states. If our results are validated, our
MidLantic Urology patients and Solaris Health affiliates may be the first to
benefit from these developments."

 

ANGLE Founder and Chief Executive, Andrew Newland, added:

"We are delighted that Solaris and MidLantic Urology have agreed to work with
ANGLE on clinical studies in prostate cancer, which build on prior work done
by Barts Cancer Institute and demonstrates the power of our leveraged research
approach. Successful development of this simple blood test could prevent men
from being subjected to unnecessary tissue biopsies when they either do not
have prostate cancer (despite the elevated level of PSA) or their cancer is
indolent and unlikely to impact either their life expectancy or quality of
life.

 

The funding for this study, which addresses a major unmet medical need, was a
key element of our capital raise last year and could open up a significant
market opportunity for ANGLE. Initiation of the study, expected in the near
future, delivers on another business milestone as we build out our commercial
plans for the Parsortix system."

 

 

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)                    +44 (0) 20 7029 8000

 Max Jones, Thomas Bective

 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 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 platforms include a circulating
tumor cell (CTC) harvesting technology known as the Parsortix(®) system and a
downstream analysis system for cost effective, highly multiplexed analysis of
nucleic acids and proteins.

 

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 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 a 200
patient clinical verification study has now completed enrolment.

 

ANGLE's technology for the multiplex evaluation of proteins and nucleic acids
of all types is called the HyCEAD(TM) 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 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 60
peer-reviewed publications and numerous publicly available posters from 31
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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