TIDMAGL
RNS Number : 7932M
Angle PLC
25 May 2022
For immediate release 25 May 2022
ANGLE plc ("the Company")
ANGLE ACHIEVES WORLD FIRST WITH FDA CLEARANCE FOR ITS PARSORTIX
SYSTEM
FDA De Novo product clearance to harvest cancer cells from blood
for subsequent analysis offers the prospect of a new era of
personalised cancer care
Parsortix liquid biopsy system cleared for use in metastatic
breast cancer
Major validation expected to fuel commercial growth
Webcast for analysts will be held at 3pm BST today
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is absolutely delighted to announce that the US Food and
Drug Administration (FDA) has cleared the Parsortix(R) system for
its intended use with metastatic breast cancer (MBC) patients.
This ground-breaking FDA clearance is the first ever FDA product
clearance to harvest cancer cells from a patient blood sample for
subsequent analysis and offers the prospect of a new era of
personalised cancer care.
The Parsortix system's capability to harvest cancer cells for
analysis from a patient blood sample has the potential to transform
treatment decisions for cancer patients as it opens up the
opportunity for repeat non-invasive biopsies to assess cancer
status. The Company believes intact living cancer cells are the
"best sample" for analysis, adding vital additional information to
the current industry approach of analysing fragments of dead cancer
cells (known as ctDNA).
FDA product clearance, which is the global gold standard for
medical devices, gives ANGLE first mover advantage for intact cell
analysis in the global liquid biopsy market, which it is estimated
will grow to over US$100 billion per annum in the United States
alone. Securing this clearance is the culmination of a sustained
effort by the Company for over six years. The credibility
associated with medical device FDA product clearance cannot be
under-estimated and we anticipate that this will turbocharge all
aspects of commercialisation of the Parsortix system and be a key
factor in its adoption by large-scale medtech and pharma
companies.
The Parsortix system approach utilises a unique technology
developed, owned and patent protected by ANGLE. We believe that
first mover advantage in the market is likely to be sustained for a
number of years and ANGLE is not aware of any competitors even
having started a similar FDA product clearance process.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"We are absolutely delighted that FDA has cleared the Parsortix
system and believe this heralds a new era for personalised cancer
care.
This ground-breaking first ever FDA product clearance in
metastatic breast cancer provides the platform for ANGLE to work
with our collaborators and customers to support further FDA
submissions and the establishment of numerous specific clinical
uses across different cancer types. By making the Parsortix system
widely available, we intend to support the entire industry in its
adoption of liquid biopsy solutions for repeat non-invasive
diagnostics for personalised cancer care. Large-scale medtech and
pharma companies now have an FDA cleared platform on which to
develop new medical solutions.
We are most grateful to over three hundred metastatic breast
cancer patients and several thousand healthy volunteer donors, who
donated blood to allow us to achieve this major breakthrough in the
adoption of liquid biopsy as a potential new standard in the care
of cancer patients. We also thank investors for providing the
considerable financial support, and patience, that has allowed us
to undertake such a substantial exercise."
Dr. James M. Reuben, Professor, Department of Hematopathology,
Division of Pathology/Lab Medicine, The University of Texas MD
Anderson Cancer Center and co-PI of the trial commented:
"My lab's overarching interest is to develop assays that will
serve as companion diagnostics to assist clinicians who treat
cancer patients (MBC and non-small cell lung cancer) with therapies
such as immune checkpoint inhibitors and targeted agents.
Therefore, we have devoted considerable effort to developing
multiple cellular assays utilizing CTCs which offer a minimally
invasive approach to monitor a patient's cancer and their response
to these therapies. Data from our trial with Parsortix showed the
system was able to effectively capture a single cancer cell in a
blood sample for analysis. We look forward to the further
development of CTC based assays that may bring enormous benefits to
patients with MBC as well as other cancers in the future."
Dr. Reuben receives research support from ANGLE, and he is
compensated as a member of its Scientific Advisory Board. This
financial relationship has been disclosed to MD Anderson's Conflict
of Interest Committee.
Dr. Naoto T. Ueno, Professor, Department of Breast Medical
Oncology, Chief of Section of Translational Breast Cancer Research,
The University of Texas MD Anderson Cancer Centre and co-PI of the
trial added:
"Liquid biopsy to collect circulating live cancer cells is an
essential tool that we need to make advancements in understanding
the biology of metastatic breast cancer. We anticipate that this
announcement may help to develop novel biomarkers, therapeutic
approaches and contribute to selecting the best treatment for
metastatic breast cancer patients."
Dr. Julie Lang, Chief of Breast Surgery and Co-Director of
Comprehensive Breast Cancer Program at Cleveland Clinic Cancer
Center, and formerly Director, USC Breast Cancer Program, Associate
Professor of Surgery, Norris Comprehensive Cancer Center,
University of Southern California commented:
"In my team's research, we have demonstrated how circulating
tumor cells harvested by this system are a good surrogate for
tissue biopsies of the metastatic site. With this regulatory
clearance we can now obtain repeat biopsies periodically to provide
up-to-date information to guide treatment decisions, improving care
and minimising invasive procedures for these patients."
Dr. Massimo Cristofanilli, a pioneer and recognized leader in
the field of liquid biopsy commented:
"Circulating tumor cells (CTCs) have long been recognized as a
robust prognostic marker in metastatic breast cancer but its
clinical application has been limited by the lack of predictive
molecular information. MBC is a heterogenous disease that requires
targeted and biological therapies and diagnostic monitoring of the
natural molecular evolution of the disease to be able to
longitudinally identify and implement the most effective treatment
and measure its benefit. I believe that the Parsortix(R) PC1 system
provides the ideal technology for such purpose allowing point of
care diagnostic capabilities that capture the complexity of the
ever-changing molecular landscape of MBC. In fact, I envision that
the clinical application of the Parsortix(R) PC1 system can result
in an unprecedented opportunity to perform a real-time molecular
diagnostic assessment of enriched CTCs with comprehensive molecular
information on both protein expression and genomic abnormalities
driving the disease."
Dr Richard Moore, Director of the Gynecologic Oncology Division,
University of Rochester Medical Center, Wilmot Cancer Institute
commented:
"As a leading translational research team, we have a long
association with the team at ANGLE and are delighted to have played
a key role in their clinical studies in an effort to bring the
Parsortix system into clinical use. Real-time analysis of live
circulating tumour cells offers the potential to transform patient
care by enabling actionable information that can guide treatment
decisions in heterogeneous and dynamic cancers such as MBC. FDA
clearance is a major advance in cancer care and we look forward to
bringing this benefit to MBC patients as well as continuing to
support further research into the advantages of CTC analysis using
the Parsortix system"
Further detail on the FDA Clearance and market potential
The FDA has granted a De Novo Class II classification for the
Parsortix system for use in harvesting cancer cells from metastatic
breast cancer (MBC) patient blood for subsequent analysis. This
means that an entirely new medical device classification has been
granted by FDA for the Parsortix system. De Novo clearance is rare
and this is the first such medical device classification for a new
instrument in oncology for many years.
This FDA regulatory clearance is the culmination of a sustained
effort by the Company for over six years including extensive
dialogue and formal pre-submissions with FDA, and the submission of
over 400 technical reports and documents and processing of over
16,000 samples to demonstrate system performance. The process has
been extremely demanding and technically challenging involving the
development of many new innovative processes, which now form part
of ANGLE's proprietary know-how, and the De Novo classification
represents the uniqueness of the Parsortix system as there is no
comparable predicate device.
The characterisation of the Parsortix system for FDA clearance
included the assessment of performance with clinical samples,
recovery, linearity, limit of detection, reproducibility,
repeatability, blood volume, blood stability and interfering
substances both exogenous and endogenous, requiring samples to be
run on the Parsortix system in the UK and at multiple clinical
sites in the United States. This process, combined with the
manufacture of the Parsortix system and associated consumables, was
completed and fully documented under ANGLE's ISO 13485:2016 quality
management system and in compliance with numerous other technical
and quality standards active in the United States and Europe. The
work was also designed to meet the requirements for European CE
Mark and ANGLE has registered the same device in the European
market allowing clinical sales in both the United States and Europe
for the intended use.
The importance of CTCs
The Directors believe that harvesting intact cancer cells from
blood (CTCs) provides the best sample of a patient's metastatic
breast cancer for assessment of ongoing patient care. CTCs offer
the potential for a wide range of downstream analyses using
established laboratory techniques, which may transform the
treatment of metastatic breast cancer, providing patients with
personalised cancer care through a non-invasive, repeat biopsy
based on a simple blood draw (a "liquid biopsy").
The analysis of CTCs may provide a "prospective view" on how the
cancer is developing and spreading whereas ctDNA is inherently
"retrospective" in nature as it comes from fragments of dead cells
and may not be representative of how the cancer is progressing.
ctDNA is a useful but more limited analyte providing only DNA
information and many patients who are matched to therapy based on
their DNA do not respond as key information about the biology of
the tumor is missing from looking at the genome alone. CTCs provide
a more complete picture on the cancer development including DNA,
RNA, and protein expression (multi-omics) as well as the potential
to undertake cytological and morphological examination of the
actual cancer cell, making it the closest potential proxy to
information that can be obtained from a metastatic tissue
biopsy.
Market potential
ANGLE anticipates that the Parsortix system will be adopted
worldwide. Market research estimates the market opportunity for
liquid biopsy in the United States alone could grow to more than
US$100 billion per annum. Despite this, ANGLE believes this FDA
classification is only the third liquid biopsy product clearance
ever granted, with the other two being limited to a single gene in
a single cancer using ctDNA (fragments of dead cells) and a system
for counting cells that does not allow downstream analysis of the
cells. ANGLE's clearance is the first and only FDA product
clearance, considered the gold standard regulatory clearance
worldwide, for a liquid biopsy solution to harvest intact cancer
cells for subsequent analysis.
Because of the critical medical need to understand how a cancer
changes over time, the current National Comprehensive Cancer
Network (NCCN) Guidelines in the United States for the treatment of
MBC patients require a tissue biopsy of the metastatic site at the
first available time point to support clinical decision-making.
Despite being recommended in the Guidelines, only around 50% of MBC
patients receive a successful biopsy as a result of patients being
too sick for the invasive procedure, the inaccessibility of the
metastatic site or insufficient tissue being available. For the
same reasons, virtually no MBC patients will have a further biopsy
of another metastatic site, despite it being well-established that
cancer develops and changes over time and there is a clear medical
need for up-to-date information on their disease status.
For those patients not able to have a successful metastatic
tissue biopsy, there is no information available to guide treatment
decisions and doctors are essentially "flying blind" in their
treatment. The Parsortix system offers an alternative method for
obtaining MBC cells for analysis, which is non-invasive and can be
repeated as often as needed. Furthermore, unlike ctDNA (fragments
of dead cells) which is limited to DNA analysis and is the focus
for most of the liquid biopsy industry, a full range of analyses
can be undertaken with circulating tumor cells (CTCs) harvested
from MBC patients by the Parsortix system including DNA, RNA and
protein analysis, as well as cytological and morphological
analysis, making it the closest potential proxy to a metastatic
tissue biopsy.
Globally, breast cancer is the most frequently diagnosed cancer
with 2.3 million new cases per year. In the United States, there
are an estimated 3.7 million women living with or after breast
cancer and a further 290,000 cases are predicted in 2022. Globally
the incidence of breast cancer is growing with cases expected to
increase by 80% between 2020 and 2040. Despite new treatment
options and advances in patient management protocols, an estimated
30% of women initially diagnosed with earlier stages of breast
cancer eventually develop recurrent advanced or metastatic disease.
Although the prognosis of patients with metastatic breast cancer
has significantly improved over the last two decades, it remains
largely incurable with a five-year survival rate of just 29%. ANGLE
estimates that the addressable market for the Parsortix system used
with metastatic breast cancer patients is in excess of US$500m per
annum in the United States alone.
ANGLE is proud to be playing a leading role in the development
of new approaches to assist the care of cancer patients and today's
announcement is testament to the passion, commitment and resilience
of our team over many years.
Webcast for analysts
A virtual meeting and webcast for analysts will be held at 3pm
BST today. If you wish to attend, please register in advance and
log on to the webcast approximately 5 minutes before 3pm. Details
of how to attend can be accessed via
https://angleplc.com/investor-relations/corporate-presentations/ .
A replay will be available shortly afterwards at the same
weblink.
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)
Max Jones, Thomas Bective +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 communicated in this announcement is inside
information for the purposes of Article 7 of Regulation
596/2015.
For Frequently Used Terms, please see the Company's website on
https://angleplc.com/investor-relations/glossary/
Notes for editors
About ANGLE plc 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(R) system and a downstream
analysis system for cost effective, highly multiplexed analysis of
nucleic acids and proteins.
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 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
59 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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