ANGLE plc 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.
Given the significant third-party interest in a new assay for quantitative HER2 analysis based on CTCs, ANGLE and BioView have agreed to allow for the inclusion of third parties in this project and its funding as we move into the commercialisation stage after the initial development work is complete. The parties are continuing to discuss strategic routes to market with potential corporate partners.
BioView President and CEO, Dr. Alan Schwebel, commented:
“We are excited for this development partnership opportunity with ANGLE, where we plan to leverage the strengths of both our technologies to develop an impactful liquid biopsy HER2 CTC test. CTCs present a unique opportunity to access protein and/or genomic alterations of HER2 throughout the patient’s cancer treatment to help ensure eligibility for the right therapy to improve patient outcomes.”
ANGLE Founder and Chief Executive, Andrew Newland, added:
“We are delighted to have entered into this partnership with BioView utilising our established bespoke assay development capability. The changing breast cancer treatment landscape has created a major commercial opportunity for a CTC-based HER2 assay allowing repeat testing and longitudinal monitoring of patients to personalise cancer care. We believe this new ‘content’ will drive wide adoption of the Parsortix system in the treatment of breast cancer.”