RCS - Angle PLC - Novel assay predicts malignancy in pelvic mass

AngleAnnouncement

12/09/2022 07:45

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220912:nRSL0228Za&default-theme=true

RNS Number : 0228Z  Angle PLC  12 September 2022

 For immediate release  12 September 2022

 

ANGLE plc ("the Company")

 

NOVEL ASSAY DEVELOPED USING THE PARSORTIX SYSTEM ACCURATELY PREDICTS
MALIGNANCY IN PELVIC MASS

 

Publication of results from ANGLE's pelvic mass pilot study in collaboration
with Wilmot Cancer Institute in a high impact journal

 

Study informed the development of ANGLE's pelvic mass triage test for
detection of ovarian cancer requiring surgical intervention

 

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is
delighted to announce the publication of results from a clinical study
undertaken in partnership with the Wilmot Cancer Institute, University of
Rochester, NY, US. The Parsortix(®) system was utilised for cancer detection
in 183 women with a pelvic mass who had a range of benign and malignant
conditions. The results have been published in the respected, high impact,
journal Obstetrics & Gynecology ("The Green Journal").

 

The population of cells captured from peripheral blood by the Parsortix system
were subjected to multiplexed gene expression analysis, and these results were
combined with serum protein biomarkers to form a predictive algorithm,
referred to as the Malignancy Assessment using Gene Identification in Captured
Cells ("MAGIC") algorithm. The MAGIC algorithm successfully and accurately
detected malignancy in women with a pelvic mass more effectively than serum
biomarkers alone. The MAGIC algorithm's unique grouping of 8 genes and 4 serum
biomarkers (ROC-AUC 95.1%, 95% CI = 92.0 - 98.2%) significantly outperformed
all individual genes (ROC-AUCs = 50.2 to 65.2%; all p<0.001), the serum
biomarker only algorithm (ROC-AUC = 89.6%, 95% CI = 84.3 - 95.0%), and the
gene only algorithm (ROC-AUC = 88.0, 95% CI = 82.9 - 93.0%, p=0.005) for the
discrimination of benign tumours from all cancers.  Importantly, MAGIC was
able to accurately identify malignancy for both early stage (ROC-AUC: 89.5%,
95% CI = 81.3 - 97.8%) and late-stage (ROC-AUC: 98.9%, 95% CI = 96.7 - 100%)
epithelial ovarian cancer. Furthermore, the algorithm not only detected
epithelial ovarian cancer, but also detected non-ovarian primary cancers and
metastatic cancers.

 

This research highlights the potential of combining the multiplexed gene
analysis of captured cells with serum biomarkers from a simple blood test for
rapid and accurate pelvic mass triage. This may help to identify the presence
of gynaecological cancers at an earlier stage whilst accurately identifying
benign conditions that could be managed locally rather than by a specialist.

 

This successful study was used to inform a clinical verification study which
is currently ongoing and from which headline results are expected shortly.
Assuming similar results, ANGLE intends to establish this test (referred to as
the Landscape+(TM) Ovarian assay) as a laboratory developed test in its own
clinical laboratories. The test has the potential to significantly improve
patient outcomes whilst at the same time reduce overall healthcare costs.

 

Approximately 5-10% of women will present with a pelvic mass during their
lifetime. For these women, accurate and early diagnosis of malignancy is
critical. Around 20,000 women are diagnosed with ovarian cancer in the US each
year. Sadly, almost 60% of cases are diagnosed when the cancer has
metastasised, resulting in a 5-year survival rate of just 31%. Current
diagnosis relies on imaging and elevated levels of serum biomarker CA-125,
which has poor specificity. Where malignancy is suspected, patients usually
undergo surgical resection. However, there is a need for more accurate and
timelier triage of patients with a pelvic mass to enable early detection of
malignancy so that these patients can be referred to high volume physicians
and institutions. It has been shown that surgical staging and debulking by
gynaecological oncologists at these high-volume institutions improves survival
for ovarian cancer patients.

 

Dr Richard Moore, Director of the division of Gynecologic Oncology, Department
of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester
commented:

"As a leading translational research team with a focus on gynecologic oncology
biomarkers, we are excited to present the results of this important study.
Ovarian cancer is difficult to detect in women with an ovarian cyst or a
pelvic mass and identifying patients at high risk is critical. Our team, in
association with ANGLE plc, created the MAGIC algorithm employing the
Parsortix system as a key tool in assisting in the detection of ovarian cancer
in patients with a pelvic mass, an area of significant unmet need. I also see
this technology as an important tool for prognostic indicators and even
diagnosis as further research is developed."

 

Professor Kyu Kwang Kim, Division of Gynecologic Oncology, Department of
Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester
added:

"This hybrid technology explores the versatility of CTC evaluation in
combination with serum biomarkers to improve the detection of cancer. The
MAGIC algorithm is an exciting advance towards more effective pelvic mass
triage."

 

ANGLE Founder and Chief Executive, Andrew Newland, added:

"Currently gene expression in CTCs is an emerging field not yet incorporated
into existing clinical risk-stratification models for ovarian cancer. This
prospective clinical trial employing novel technology introduces the
combination of CTC and serum biomarker analysis and is therefore an important
milestone towards improving pelvic mass triage. We now look forward to
receiving the headline results from an ongoing clinical verification study in
this setting, and we anticipate that the Landscape+ Ovarian assay will be
ANGLE's first laboratory developed test to be offered from our own clinical
laboratories."

 

The research has been published as a peer-reviewed publication in the Journal
Obstetrics & Gynecology and will be available online at
https://angleplc.com/library/publications/
(https://angleplc.com/library/publications/) .

 

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

 Max Jones, Thomas Bective

 FTI Consulting

 Simon Conway, Ciara Martin                  +44 (0) 203 727 1000

 Matthew Ventimiglia (US)                    +1 (212) 850 5624

 

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 68
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.

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word “Reach” in the source column of the News Explorer pages of London Stock Exchange’s website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAFFLLFLKLBBBK