- Additional contract for a new clinical trial
- Parsortix system for use in longitudinal follow-up of patients with unresectable solid tumors
GUILDFORD, UK / ACCESSWIRE / June 22, 2022 / ANGLE SA (AIM:AGL)(OTCQX:ANPCY), a global leader in liquid biopsy, is delighted to announce that the company has been awarded an additional contract with its first large-scale pharmaceutical services customer. The client, a pharmaceutical company with numerous cancer drugs in development and revenues exceeding US$1 billion per year, again chose ANGLE’s Parsortix® to undertake longitudinal monitoring (i.e. before, during and after drug intervention) of patients with certain unresectable solid tumors in a new phase Ib dose-escalation study using its investigational drug in combination with immuno-oncological agents. Once the recommended dose has been determined, the study will move into an expansion phase.
The additional contract is expected to be worth up to US$1.2 million over a multi-year period. The new work relates to the successful progression of one of the smaller Phase I studies of the initial contract announced in April 2021. This dose escalation study, with expansion phase, is expected to begin in the coming weeks and the client s expects to provide samples from each patient for analysis by ANGLE at seven separate times. As with previous contracts, ANGLE anticipates that this new Phase Ib study, if successful, could evolve into larger Phase II studies and, potentially, much larger Phase III studies.
As with the original contract, the agreed services cover the capture, harvesting and analysis of circulating tumor cells (CTCs) and CTC clusters. Samples will be shipped from multiple study centers to ANGLE’s clinical laboratories in the UK and US for analysis using the Parsortix system.
ANGLE Founder and Managing Director Andrew Newland commented:
“We have previously indicated that we expect repeat customers from our pharmacy service customers. We believe the Parsortix liquid biopsy has particular advantages in capturing intact cancer cells, including mesenchymal cells and clusters, and provides the opportunity for longitudinal testing in a clinical setting. This is not possible with tissue biopsy.
The additional contract from our first large-scale pharmaceutical customer, along with ongoing discussions with several potential new customers, validates ANGLE’s belief that longitudinal CTC monitoring is a very attractive proposition for the pharmaceutical industry looking for new information about cancer drug trials.
We are very pleased with the growing interest from pharmaceutical companies in our CTC analysis services following the FDA approval of the Parsortix system and look forward to reporting further progress in expanding this important area of testing. activity for ANGLE in due course. »
For more information:
+44 (0) 1483 343434
Andrew Newland, Managing Director
Berenberg (NOMAD and co-broker)
+44 (0) 20 3207 7800
Jefferies (Joint Broker)
+44 (0) 20 7029 8000
Simon Conway, Ciara Martin
+44 (0) 203 727 1000
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Notes for Editors
About ANGLE plc www.angleplc.com
ANGLE is one of the world leaders in liquid biopsy with sample-response solutions. ANGLE’s proven patented platforms include a circulating tumor cell (CTC) harvesting technology known as Parsortix® and a downstream analysis system for cost-effective, highly multiplexed analysis of nucleic acids and proteins.
ANGLE Parsortix® The 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.
The Parsortix® The PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTC) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system uses a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in the blood. Cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream analyses. The end user is responsible for validating any downstream testing. The stand-alone device, as stated, does not identify, enumerate or characterize CTCs and cannot be used to make diagnostic/prognostic statements for CTCs, including indications for monitoring or as an aid to management disease and/or treatment decisions.
The Parsortix system allows a liquid biopsy (a simple blood test) to be used to provide the user with circulating metastatic breast cancer cells in a format suitable for several types of downstream analysis. 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 CTC phenotypes (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable (live) form. The CTCs harvested from the system provide a complete picture of a cancer; as an intact cell, they allow DNA, RNA and protein analysis as well as cytological and morphological examination and can provide analysis comparable to tissue biopsy in metastatic breast cancer. As CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer grows and changes over time and there is a clear medical need for up-to-date information about a patient’s tumor status. Additionally, live CTCs harvested by the Parsortix system can be cultured, providing the opportunity to test tumor response to drugs outside of the patient.
Parsortix technology is the subject of 26 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three broad patent families in development worldwide.
In the United States, the Parsortix® The PC1 system has received a Class II classification from the FDA for use with patients with metastatic breast cancer. FDA clearance is considered the global gold standard. ANGLE’s Parsortix system is the first-ever FDA cleared system for harvesting CTCs for further analysis. ANGLE has applied the CE IVD mark to the same system for the same intended use in Europe.
ANGLE has also completed two separate clinical studies of 200 subjects as part of a program designed to develop a pelvic mass triage test for ovarian cancer, with results showing best-in-class accuracy (AUC-ROC) of 95.1%. The pelvic mass triage test has been refined and optimized and a clinical verification study of 200 patients has now completed recruitment.
ANGLE’s technology for multiplex evaluation of proteins and nucleic acids of all types is called HyCEADMT platform and is based on patented flow-through-matrix technology. It enables low cost, highly multiplexed, fast and sensitive capture of targets from a wide variety of sample types. A proprietary chemical approach (the HyCEAD method) allows the capture and amplification of more than 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 has been used in the ovarian cancer pelvic mass triage test to obtain the best accuracy of its class (AUC-ROC) of 95.1%.
ANGLE’s proprietary technologies can be combined to deliver automated, sample-to-response results in centralized lab and point-of-use cartridge formats.
ANGLE has established formal collaborations with world-class cancer centers and leading companies such as Abbott, Philips and QIAGEN, and works closely with key CTC translational research clients. These Key Opinion Leaders (KOLs) strive to identify applications with medical utility (clear patient benefit) and obtain clinical data that demonstrates this utility in patient studies. The body of evidence for the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer, as well as KOLs with 62 peer-reviewed publications and numerous posters publicly available from 31 independent cancer centers, available on our website.
ANGLE has established clinical services laboratories in the UK and US to accelerate the commercialization of the Parsortix system and act as demonstrators to support product development. The labs provide services globally to pharmaceutical and biotech customers for the use of Parsortix in cancer drug trials and, once the labs are accredited and the assays validated, will provide laboratory-developed assays (LDTs) for the patient management.
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THE SOURCE: ANGLE SA
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