REG - Angle PLC - Positive headline results from ovarian study

AngleAnnouncement

29/09/2022 07:00

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RNS Number : 0755B  Angle PLC  29 September 2022

 For immediate release  29 September 2022

 

ANGLE plc ("the Company")

 

ANGLE REPORTS POSITIVE HEADLINE RESULTS FROM OVARIAN CANCER CLINICAL
VERIFICATION STUDY

 

Parsortix test successful in discriminating malignant and benign abnormal
pelvic masses from a simple blood draw for detection of ovarian cancer

 

Best in class results indicate the potential to reduce both false positives
and false negatives by 50% or more

 

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is
delighted to announce positive headline results from its ovarian cancer
clinical verification study, demonstrating that a Parsortix(®) blood test can
be used to determine if a woman is at risk of a malignant pelvic mass.
Following the recent FDA clearance and CE Marking of the Parsortix PC1 system
for use in metastatic breast cancer, this achievement marks another important
milestone in the Company's commercialisation strategy.

 

The study evaluated blood samples from patients diagnosed with a pelvic mass
and was led by Dr Richard Moore at the University of Rochester Medical Centre,
Wilmot Cancer Institute in New York, Unites States. 144 patients (48 of which
were found to have a malignancy following surgery) had blood samples shipped
to ANGLE's laboratory for processing and evaluation. The population of cells
captured and harvested using the Parsortix system were evaluated using ANGLE's
Landscape(+) Ovarian assay to determine the expression levels of 164 different
gene transcripts. Analysis of the data produced an algorithm for the
prediction of the risk of malignancy that combines the physician's initial
cancer risk assessment (benign vs. malignant), the patient's age, and the RNA
expression levels of 23 different genes.

 

The area under the receiver operating characteristic curve (ROC-AUC) for this
predictive algorithm was 95.4%, a level which is considered "Excellent"(1).
Employing a threshold of ≥40% for the risk probability (a value of between 0
- 100% that is generated by the algorithm using the patient specific inputs)
resulted in a sensitivity of 90%, a specificity of 93%, a positive predictive
value (PPV) of 86%, a negative predictive value (NPV) of 95%, a false positive
rate (FPR) of 7%, a false negative rate (FNR) of 10%, and an accuracy of 92%.
Compared to the physician's initial cancer risk assessment for this patient
cohort (which had a sensitivity of 75%, a specificity of 86%, a PPV of 74%, a
NPV of 87%, a FPR of 14%, a FNR of 25% and an accuracy of 83%), the predictive
algorithm would significantly aid the physician in their risk assessment, and
in particular, reduced both the FPR and the FNR by 50% or more.

 

The performance of the Parsortix Landscape(+) Ovarian assay in this study was
in-line with the high level of accuracy demonstrated in an earlier 200 patient
multicentre clinical study reported in 2018 (ROC-AUC 95.1%) and achieved the
Company's objective of best in class results with both sensitivity and
specificity of 90% or greater.

 

ANGLE believes the clinical data reported today provides a clear demonstration
of the value of the Parsortix harvest of circulating tumour cells as the "best
sample" for subsequent analysis as a liquid biopsy. This is possible because
the Parsortix system recovers intact living cancer cells in the patient blood,
which contrasts with other tests based on free-floating proteins that can be
upregulated for reasons other than cancer.

 

In contrast to ANGLE's previously reported MAGIC algorithm(2), the new
algorithm utilises more comprehensive gene expression information derived from
blood samples shipped overnight to a central laboratory, uses a lysis buffer
that does not require the separate extraction of RNA from the population of
cells captured by the Parsortix system, and does not directly rely on the use
of serum biomarkers. The clinical results therefore demonstrate the ability to
undertake complex molecular analysis of the Parsortix harvest and confirms its
suitability for use in both hospital laboratories and central laboratories
requiring sample shipping. ANGLE believes that these key findings provide
evidence of the potential for widespread use of the Parsortix system for
molecular analysis in numerous different cancer applications adding greatly to
the value of the FDA cleared Parsortix system.

 

Following these excellent results, ANGLE is finalising detailed plans for the
commercialisation of Parsortix Landscape(+) molecular assays including, but
not limited to, ovarian cancer and will update the market once these are
complete.

 

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"Demonstration of clinical utility of the Parsortix system is a key strategic
goal for ANGLE, so the excellent results from this study are validation of
what can be achieved in a demanding clinical setting. Further, these results
demonstrate the capability to undertake a complex molecular analysis of the
Parsortix harvest in a real world setting. This important capability has
potentially numerous, widespread alternative uses, reinforcing our belief that
a Parsortix harvest of circulating tumour cells from a liquid biopsy offers
the "best sample" for clinicians seeking actionable information to guide
patient cancer treatment."

 

1.   The area under the curve (AUC) for a receiver operating characteristic
(ROC) plot, a plot of 1-specificity on the x-axis vs. the sensitivity on the
y-axis at each possible threshold for a test's results, is a measure of the
test's accuracy. The accuracy of the test depends on how well the test
separates the two groups being tested into those with the outcome
(sensitivity) and those without the outcome (specificity) in question.  An
AUC of 1 (100%) represents a perfect test while an AUC of 0.5 (50%) represents
a worthless test.  The traditional academic classification system for
ROC-AUCs is 90% to 100% = excellent; 80% to 90% = good; 70% to 80% = fair; 60%
to 70% = poor; 50% to 60% = fail. Source: University of Cambridge MRC Unit.

https://imaging.mrc-cbu.cam.ac.uk/statswiki/FAQ/roc
(https://imaging.mrc-cbu.cam.ac.uk/statswiki/FAQ/roc)

 

2.   Moore RG, Khazan N, Coulter MA, Singh R, Miller MC, Sivagnanalingam U,
DuBeshter B, Angel C, Liu C, Seto K, Englert D, Meachem P and Kim KK.
Malignancy Assessment Using Gene Identification in Captured Cells ("MAGIC")
Algorithm for the Prediction of Malignancy in Women With a Pelvic Mass. Obstet
Gynecol  Online ahead of print, September 08, 2022.

https://pubmed.ncbi.nlm.nih.gov/36075062/

 

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

 

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 70
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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