ANGLE Announces Partnership With BioView to develop a liquid biopsy circulating tumor cell (CTC) HER2 assay for breast cancer, 19 April 2023
ANGLE plc (AIM:AGL), (OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce it has signed an agreement with BioView Ltd. (“BioView”) (BIOV.TA) to develop a liquid biopsy circulating tumor cell (CTC) HER2 assay for breast cancer utilising ANGLE’s FDA cleared Parsortix® PC1 Clinical System to harvest CTCs and BioView’s automated microscopy systems and software to detect and assess the HER2 expression and/or gene amplification in CTCs.
BioView develops, manufactures and markets innovative automated cell imaging and analysis solutions and has received FDA product clearance for its fluorescent in situ hybridisation (FISH) application for HER2 analysis of FFPE breast tissue sections, hybridised with Abbott’s PathVysion HER2 DNA probe kit. ANGLE has already successfully integrated BioView’s technology in its R&D and clinical laboratories for assay development and pharma services.
ANGLE and BioView will now begin the programme of developing a HER2 assay for the detection of HER2 protein via immunofluorescence (IF) and HER2/neu gene amplification by FISH, utilising Abbott’s PathVysion HER2 DNA probe kit, in CTCs from breast cancer patients’ blood samples harvested using ANGLE’s FDA cleared Parsortix PC1 Clinical System and analysed using BioView’s automated imaging and analysis technology.
It is recognised that breast cancer can be highly heterogeneous and that HER2 status can change over time. In addition, results from a recent high impact study have revealed that patients categorised with HER2-low breast cancer (and defined as immunohistochemistry (IHC) score 1+ and 2+ and HER2-negative by FISH), can in fact, benefit from new HER2 targeted antibody-drug conjugates, where typical HER2 targeted drugs have previously been reserved for HER2-positive (HER2 IHC 3+ and/or HER2 FISH positive) breast cancer patients. This new understanding is driving the adoption of HER2-low targeted drugs such as ENHERTU® marketed by Daiichi-Sankyo and AstraZeneca.
This changing market dynamic has provided ANGLE and BioView with a major commercial opportunity to develop a quantitative CTC-based HER2 assay, to assess HER2 protein expression and/or gene amplification levels by analysing fluorescence intensities. This would be the only product-based solution on the market for this purpose leveraging both companies’ previous FDA product clearances. Unlike current standard of care tests developed for use on FFPE tissue, a CTC HER2 assay could be used for longitudinal monitoring of HER2 status throughout disease progression, thereby ensuring the patient is targeted for the most appropriate treatment at every stage. The development phase is estimated to take around a year to complete with the assay development work generating c. £1.2 million of revenues for ANGLE.
HER2-low breast cancer accounts for 55% of all breast cancer cases whereas HER2-positive cancer accounts for 25% of cases. The new use of trastuzumab deruxtecan (ENHERTU®) to include HER2-low patients has resulted in analysts predicting up to a US$3 billion annual increase in sales value. Because of market expansion into HER2-low patients, and the need for novel biomarkers enabling ongoing patient monitoring of HER2 status, ANGLE and BioView believe there will be demand from medtech and pharma companies for quantitative CTC-based HER2 detection assays to enable regular and accurate stratification of patient populations.
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® system, and it enables a liquid biopsy (a simple blood test) to be used to provide the cells of interest 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 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 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 FDA clearance is in process for the United States with a 400 subject clinical study and associated analytical studies in metastatic breast cancer. 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 optimization, 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 HyCEADTM Ziplex® 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 centralized laboratory and point–of-use cartridge formats.
ANGLE has established formal collaborations with world-class cancer centers 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 28 peer-reviewed publications and numerous publicly available posters, available on our website.
About BioView Ltd www.bioview.com
For nearly two decades BioView has been developing, manufacturing and marketing innovative automated cell imaging and analysis solutions, for use in cytology, cytogenetic, pathology clinical and research laboratories. Founded and managed by experts in the areas of medical devices, clinical and research applications, and automated scanning systems, BioView leverages its knowledge and expertise in the development of a dedicated scanner, designed to address the specific challenges of CTC imaging, analysis and reporting.
BioView is a publicly traded company on the Tel Aviv Stock exchange, and currently has strategic collaborations underway with international scientific leaders and institutions. For more information about the BioView technology, and press related issues, please contact firstname.lastname@example.org or visit our website at www.bioview.com