TIDMAGL
RNS Number : 0435L
Angle PLC
28 April 2020
For immediate release 28 April 2020
ANGLE plc ("the Company")
BUSINESS UPDATE
Progress across multiple fronts
In-house capability developed to determine CTC PDL1 status for
immunotherapy trials
COVID-19 highlights crucial need for liquid biopsy for cancer
patients
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to provide an update on the Company's progress
since the COVID-19 lock down started.
As announced on 31 March 2020, ANGLE's operations in the UK,
Canada and USA have been impacted by the COVID-19 pandemic and the
resulting Government directives, notably in relation to completion
of the remaining analytical samples required for the Company's FDA
submission and patient enrolment for the Company's ovarian cancer
clinical verification study.
Following a period of unanticipated disruption and delay caused
by COVID-19, a key focus during lock down is on finalising the
significant amount of written documentation and analysis for the
FDA submission, so that this can be rapidly submitted once the
remaining analytical samples are available and analysed. This is
progressing well and it is expected that submission can be made
promptly once restrictions ease so that we can secure the remaining
healthy volunteer blood samples needed to complete the analytical
study work.
The Company has adopted a proactive approach to the lock down
advancing on multiple fronts and developing some new
initiatives.
R&D, product development and engineering work
The Company's Guildford UK laboratories are now operating with a
skeleton crew, double shift operation with enhanced social
distancing and other precautions in place to enable the progression
of experimental and engineering work that does not require access
to donor blood. This work is supporting key Parsortix(R) system
R&D, product development and engineering activities.
Ovarian cancer test
The Company's Toronto Canada laboratories are open for technical
personnel who cannot work from home, also with double shift
operation and enhanced social distancing and other precautions in
place. This is enabling HyCEAD(R) Ziplex(TM) analytical and assay
verification work for the ovarian cancer test to progress.
The University of Rochester Medical Center Wilmot Cancer
Institute, New York has temporarily ceased patient enrolment. In
the absence of the current clinical verification study samples, the
decision has been taken to analyse the second retained samples from
the previous ovarian cancer clinical study. This was a duplicate
blood sample from every patient that was processed on Parsortix and
then stored as a frozen lysate. Analysis of these samples will use
the further optimised HyCEAD Ziplex cancer gene panel planned for
the current study.
This may allow the Company to generate clinical results in the
middle of the year to assist in the negotiations with clinical
laboratory partners that might wish to implement the test, ahead of
the data from the current clinical verification study being
available.
PDL1 assessment capability
As announced on 17 April 2020, the Molecular Diagnostics
Laboratory focused on Liquid Biopsy (ACTC lab) at the Department of
Chemistry, University of Athens published multi-year work in Nature
Scientific Reports, demonstrating the use of the Parsortix system
for enabling the molecular analysis of circulating tumor cells
(CTCs) in head and neck cancer (HNSCC), including the investigation
of PDL1 (programmed death-ligand 1) expression, a key target for
leading immunotherapy drugs. This followed multi-year work by
University Medical Centre Hamburg-Eppendorf (UKE) published in
Cancers as announced on 21 June 2019, demonstrating use of the
Parsortix system for PDL1 molecular analysis in non small cell lung
cancer (NSCLC) patients.
ANGLE R&D staff have been working extensively on an
immunofluorescence (IF) imaging assay for determination of PDL1
expression levels in CTCs harvested by the Parsortix system. Since
lock down, this work has been completed and we now have a method
for assessing the presence and number of PDL1 positive and PDL1
negative CTCs in patient blood samples. This approach examines
actual cells (cytological analysis) as opposed to molecular
analysis approaches, which work with cell lysates (nucleic contents
of cells that have been broken open, analysed as a mixture).
Currently the PDL1 expression assay is Research Use Only, we are
examining options for clinical development.
The newly developed inhouse cell-based approach will enable use
of the Parsortix system to assess PDL1 status using two
complementary techniques, molecular analysis and cell imaging (IF).
We believe this is a powerful combination, which, together with the
key advantages of the Parsortix system to capture both epithelial
and mesenchymal CTCs (traditional antibody-based systems fail to
capture the clinically relevant mesenchymal CTCs) and to capture
CTC clusters, may provide significant benefits to the pharma
services market.
Pharma services cancer drug trials
There are numerous immunotherapy cancer drug trials in progress
or planned where assessment of PDL1 status on CTCs from patient
blood samples may have a major bearing on whether the trial is
successful. The new trials being planned are targets for adoption
of the Parsortix system and ANGLE is developing a service
capability to be able to process samples on a commercial basis as
part of these trials.
ANGLE has established a proactive business development process,
taking advantage of the increased accessibility of key executives
during lock down, to establish dialogue with prospective customers
and collaborators for the deployment of PDL1 analysis capabilities
in pharma services cancer drug trials.
The investigation of PDL1 is a key target for leading
immunotherapy drugs such as Pembrolizumab (also known as Keytruda
from Merck), Nivolumab (also known as Opdivo from BMS), Durvalumab
(also known as Imfinzi from AstraZeneca) and Atezolizumab (also
known as Tecentriq from Roche). As of September 2019, there were
2,975 active drug trials targeting PDL1 (and the receptor to which
it binds, PD1), planning to recruit over 500,000 patients. Thus,
there is a need for an effective biomarker strategy to identify
responding patients (Source:
https://www.nature.com/articles/d41573-019-00182-w ), which we
believe the Parsortix system is now capable of meeting.
Other financial matters
In addition to these proactive efforts, ANGLE has taken steps to
manage resources and has furloughed a number of staff who are
unable to work remotely in the current situation in order to
protect their jobs whilst temporarily reducing the Company's
operating costs. We have also received the R&D tax credit due
from HMRC of GBP1.9 million referred to in our 31 March 2020
announcement. As previously reported, ANGLE has sufficient cash for
planned operations until mid-2021.
Impact of COVID-19 on cancer patients
During lock down, 'non-essential' screening, surgical and other
procedures in cancer treatment have been postponed, delayed or
cancelled by clinical institutions across the world. This extends
to procedures such as tissue biopsies both of primary cancer sites
for diagnosis and secondary cancer sites for treatment selection.
The delay of these procedures may have significant adverse impacts
for patients. This highlights the need for the regulatory approval
of a CTC based liquid biopsy alternative to such invasive tissue
biopsy procedures. Harvested cancer cells from a simple blood test
that could be used to progress a patient's diagnosis and treatment
while reducing the time to answer delays associated with the
processing and pathological evaluation of tissue biopsies would be
extremely valuable.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"Our business continuity plans are proving robust and I am
extremely pleased with the dedication our staff have shown in
adapting to working under the current restrictions. The
developments we have made in assessing PDL1 status present an
opportunity for ANGLE to address the pharma services market.
During the lock down period, 'non-essential' screening, surgical
and other procedures in cancer treatment have been postponed,
delayed or cancelled globally. This situation highlights the need
for the regulatory approval of a CTC liquid biopsy alternative to
invasive tissue biopsy procedures as delay in these procedures can
have serious adverse impacts for cancer patients.
ANGLE is even more determined to complete the many years of work
already undertaken to obtain the first ever FDA regulatory
clearance for a simple blood test to harvest cancer cells for
analysis. We will be ready to promptly complete our FDA submission
once we are permitted to secure the remaining healthy volunteer
blood samples needed. "
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance - Carl Holmes, Simon
Hicks
ECM - Alice Lane, Sunila de Silva +44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks, Andrew Craig,
Chris Lee +44 (0) 203 705 9330
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
http://www.angleplc.com/the-parsortix-system/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 and a downstream analysis system for cost effective,
highly multiplexed analysis of nucleic acids and proteins.
ANGLE's cell separation technology is called the Parsortix(R)
system, and it enables a liquid biopsy (a simple blood test) to be
used to provide cells of interest to users in a format suitable for
multiple types of downstream analyses. The system uses a
microfluidic device that captures cells based on a combination of
their size and compressibility. The system is epitope independent
and can capture all types of CTCs as well as CTC clusters in a
viable form (alive). CTCs enable the complete picture of a cancer
to be seen, as being a complete cell, they allow DNA, RNA and
protein analysis, and the live cells harvested can also be
cultured. The Parsortix technology is the subject of 24 granted
patents in Europe, the United States, China, Australia, Canada,
India, Japan and Mexico with three extensive families of patents
are being progressed worldwide. The Parsortix system has a CE Mark
in Europe for the indicated use and submission to FDA for clearance
is in process for the United States using results from two separate
clinical studies of over 250 metastatic breast cancer patients and
associated analytical studies. ANGLE is seeking to be the first
ever FDA cleared CTC harvesting system and only the third ever FDA
cleared liquid biopsy test. ANGLE has already undertaken 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 (ROC-AUC) of 95.1%. The pelvic mass
triage assay has undergone further refinement and optimisation, and
is currently in the process of a 200 patient clinical verification
study.
ANGLE's technology for the multiplex evaluation of proteins and
nucleic acids of all types is called the HyCEAD(TM) Ziplex(R)
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 Ziplex 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 (ROC-AUC)
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
31 peer-reviewed publications and numerous publicly available
posters, available on our website.
This information is provided by RNS, the news service of the
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Authority to act as a Primary Information Provider in the United
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of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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