REG - Angle PLC - Breakthrough clinical results

AngleAnnouncement

04/01/2024 07:00

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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(®)) marketed by Novartis

·    EGFR (T790M): Tagrisso (Osimertinib(®)) marketed by Astra Zeneca

·    ESR1 (K303R): Elacestrant (Oserdu(®)) marketed by Menarini

·    MTOR (T1977K): Everolimus (Afinitor(®)) 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)            +44 (0) 20 3207 7800

 Toby Flaux, Ciaran Walsh, Milo Bonser

 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

 

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(®) 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(®) 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
(http://www.angleplc.com)

 

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