TIDMAGL
RNS Number : 5877Y
Angle PLC
04 January 2024
For immediate release 4 January 2024
ANGLE plc ("the Company")
BREAKTHROUGH CLINICAL RESULTS PROVIDE A UNIQUE INSIGHT INTO THE
PROGRESSION OF EACH PATIENT'S CANCER
Combined DNA Next Generation Sequencing of CTCs and ctDNA from
the same blood sample highlights potential for the Parsortix system
to identify key variants (DNA mutations) missed by other approaches
to help guide treatment decisions
The new DNA sample-to-answer molecular solution combining CTC
and ctDNA analysis is expected to be a driver of product and pharma
services sales
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company with innovative circulating tumour cell (CTC) diagnostic
solutions for use in research, drug development and clinical
oncology, is delighted to announce breakthrough results from DNA
molecular analysis of cancer patient blood samples that provide a
unique insight into the progression of each patient's cancer and
how this may be treated.
Expansion of the Parsortix system downstream analysis into DNA
molecular analysis utilising leading third party Next Generation
Sequencing (NGS) systems has been a longstanding objective for
ANGLE and the results now achieved will allow ANGLE to expand both
its product sales and pharma services offerings.
ANGLE has developed sample-to-answer solutions for real-time NGS
DNA analysis of both ctDNA (fragments of DNA released mainly by
dying cells) and CTCs (living cancer cells) from a single tube of
patient blood. Results announced today come from forty-seven
patient samples in breast, lung, prostate and ovarian cancers
analysed for both ctDNA and CTC-DNA using a pan-cancer panel run on
an Illumina NGS system.
Widely accepted actionable DNA variants (cancer mutations) were
identified in CTCs that were not present in the ctDNA from the same
blood draw in 70% of breast cancer patient samples, 70% of lung
cancer patient samples and 60% of ovarian cancer patient samples.
Furthermore, the actionable variants identified in the CTCs that
were not present in the ctDNA included variants targeted by widely
used FDA approved drugs for cancer care.
ANGLE believes that molecular profiling of CTC-DNA alongside
ctDNA from the same patient blood sample has the potential to
revolutionise the way that cancer is treated. Ultimately, such
combined profiling may enable oncologists through routine repeat
blood tests to track the clonal evolution of the patient's cancer,
informing on treatment decisions, monitoring response to treatment,
highlighting drug resistance mechanisms, and signalling disease
progression. This will serve to improve patient outcomes and to
focus healthcare expenditure by supporting the best therapy choices
and maximising the likelihood that treatment will be
successful.
ANGLE will start using the clinical results announced today to
support the offer of sample-to-answer DNA molecular solutions to
pharma services customers using the combined CTC-DNA and ctDNA
analysis.
ANGLE will also be working with key opinion leaders (KOLs) and
clinicians to expedite the clinical adoption of the combined
molecular profiling approach, including the formal establishment of
performance under analytical conditions, and through carefully
designed clinical studies to build on the promising patient cohort
data presented.
ANGLE Chief Scientific Officer, Dr Karen Miller, commented:
"This new clinical evidence highlights the strength of the
Parsortix system to provide the best possible sample for analysis,
enabling DNA profiling of both the living CTCs and ctDNA released
from dead cells from the patient's cancer. We are particularly
excited about finding such high levels of additional variants in
the CTCs that are not present in ctDNA, as this provides
potentially additional information for the clinicians on which to
base their treatment options."
ANGLE Chief Executive Officer, Andrew Newland, commented:
"Today's breakthrough is the critical next step post the FDA
clearance to show in a sample-to-answer format the potential
clinical value of NGS molecular analysis on a repeat basis of
living cancer cells harvested from patient blood samples. ANGLE is
committed to delivering transformational benefits to cancer
patients through a simple blood test. This is a major step in this
process and I am enormously proud of the ANGLE team in achieving
this."
Technical background information
Utilising its Parsortix system, ANGLE has now pioneered the
combined analysis of ctDNA (DNA fragments released from dead cancer
cells into the blood) and CTCs (living cancer cells in the blood
involved in the active metastasis of the cancer as it spreads to
secondary cancer sites) from the same tube of blood using the same
NGS molecular analysis. This process enables real time analysis of
the progression of cancer in both living and dead cancer cells
simultaneously, providing additional potentially clinically
relevant information over and above that obtained for each analyte
alone. ANGLE's Parsortix system combined with NGS DNA analysis
gives a completely new insight into cancer clonal evolution not
currently available to researchers or oncologists.
Key elements of the results to date are that:
1) The process involved extraction of the plasma for ctDNA
analysis in accordance with standard industry approaches ahead of
processing the blood cellular component on the Parsortix system to
harvest CTCs for analysis. The plasma extraction has been
demonstrated to have no impact on the CTC analysis and does not
impair any Parsortix downstream analysis that may be chosen. This
is critical as ANGLE's aim is to demonstrate the additional benefit
to analysing CTCs alongside ctDNA utilising the same NGS molecular
analysis techniques already developed for ctDNA allowing the
industry to easily adopt the expanded approach.
2) DNA variants were identified in every patient sample
processed and passed the quality control criteria.
3) Both the CTCs and the ctDNA were sequenced using identical
protocols. The CTC analysis provided additional information beyond
that which could be obtained from ctDNA alone. Some variants were
found only in ctDNA, the hypothesis being that the therapy and/or
immune system dealt with these. Some variants were found in both
ctDNA and CTCs, the hypothesis being that the therapy was partially
effective but remaining tumour cells with the potential to seed
metastases remained in the blood. Some variants were found in the
CTCs but not in the matching ctDNA fraction, in particular for the
lung and breast cancer patients, the hypothesis being that these
represent clonal evolution, which has not been addressed by either
the immune system or the therapy, highlighting the important
additional information that can be generated by profiling CTCs, and
opening up new treatment options for the benefit of patients.
4) Actionable variants identified in our patient cohort in the
CTCs that were not present in the ctDNA included variants targeted
by widely used drugs from many large pharma companies, for
example:
-- PIK3CA (E545K): Alpelisib (Piqray(R) ) marketed by Novartis
-- EGFR (T790M): Tagrisso (Osimertinib(R) ) marketed by Astra Zeneca
-- ESR1 (K303R): Elacestrant (Oserdu(R) ) marketed by Menarini
-- MTOR (T1977K): Everolimus (Afinitor(R) ) marketed by Novartis
-- ERBB2 (R678Q): Trastuzumab, Pertuzumab, Neratinib, Afatinib
marketed respectively by Astra Zeneca, Roche Genentech, Puma
Biotechnology, and Boehringer Ingelheim
5) As well as the unique insight provided by DNA analysis of the
CTCs harvested by the Parsortix system, the CTC sample offers the
potential to extend the analysis from DNA to RNA, protein, and
morphological analysis of CTCs and CTC clusters, all of which
together make the intact living cancer cell (CTC) the best sample
for repeat non-invasive testing to drive personalised care for
cancer patients.
ANGLE is engaging with Illumina, leading KOLs and oncologists to
seek their input and consideration of the benefits of the combined
ctDNA / CTC-DNA approach giving a new and unique insight into
cancer clonal evolution. The early stage responses have been
encouraging.
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Berenberg (NOMAD and Broker)
Toby Flaux, Ciaran Walsh, Milo Bonser +44 (0) 20 3207 7800
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/
Notes for editors
About ANGLE plc
ANGLE is a world-leading liquid biopsy company with innovative
circulating tumour cell (CTC) diagnostic solutions for use in
research, drug development and clinical oncology using a simple
blood sample. ANGLE's FDA cleared and patent protected circulating
tumour cell (CTC) harvesting technology known as the Parsortix(R)
PC1 System enables complete downstream analysis of the sample
including whole cell imaging and proteomic analysis and full
genomic and transcriptomic molecular analysis.
ANGLE's commercial businesses are focusing on diagnostic
products and clinical services. Diagnostic products include the
Parsortix(R) system and associated consumables. The clinical
services business is offered through ANGLE's GCP-compliant
laboratories. Services include custom made assay development and
clinical trial testing for pharma.
Over 90 peer-reviewed publications have demonstrated the
performance of the Parsortix system. For more information, visit
www.angleplc.com
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