ANGLE said that it has concluded the development of two liquid biopsy assays for AstraZeneca, designed for prostate cancer and multi-cancer DNA damage response (DDR) detection.
The completion of these projects enables AstraZeneca to apply the assays in clinical trials, with blood sample testing now underway, said the UK-based liquid biopsy company.
The assays, an androgen receptor (AR) assay for prostate cancer and a DDR micronuclei assay to assess DNA damage, have been validated for use.
ANGLE is also exploring additional areas where AstraZeneca could integrate circulating tumour cell (CTC) analysis. The AR and DDR assays will now be offered to pharmaceutical clients as part of ANGLE’s clinical laboratory services.
ANGLE CEO Andrew Newland said: “Successful completion of the AstraZeneca assay development projects is a key milestone for the Company in progressing our aim for Parsortix-based CTC analysis to be widely adopted for new and existing drugs to identify the right drug for the right patient at the right time.
“There is a clear business case for AstraZeneca and other large pharma to expand their markets for existing drugs by identifying patients expressing the target biomarker on CTCs, as biomarker status can change over time and impact response to treatment.”
The AR therapeutic market is projected to reach $9.2bn in 2033, with an increasing focus on targeted therapies and personalised medicine. More than 46,000 patients are currently enrolled in AR clinical trials across 181 studies, presenting commercial opportunities for ANGLE’s technology.
The DDR sector, valued at $8.2bn in 2024, is expected to grow to $30.3bn within the next decade. The complexity of DNA repair mechanisms necessitates precise clinical evaluations, making real-time drug impact assessments crucial.
Currently, over 16,000 patients are involved in 133 DDR clinical trials, highlighting potential demand for ANGLE’s DDR micronuclei assay alongside its γH2AX and pKAP1 DDR assays.
ANGLE has also completed its contract with Eisai, providing CTC analysis for a Phase 2 study assessing HER2 status in breast cancer patients. The study focused on BB-1701, a HER2-targeting antibody-drug conjugate (ADC).
Findings demonstrated that HER2 CTC status changed over time, with variations observed between pre- and post-treatment samples from the same patient.
The data suggests that ANGLE’s Parsortix-based HER2 assay could enable dynamic HER2 status monitoring, which is not feasible with traditional tissue biopsies. This capability is particularly relevant for ADC clinical trials, where treatment response assessments are critical.
The HER2 therapeutic market, valued at $9.4bn in 2023, is projected to grow to $13.2bn by the end of this decade. The increasing use of monoclonal antibodies and ADCs is driving demand, with 481 new ADC trials launched last year, HER2 being the most targeted biomarker.
These trends are said to underscore potential applications for ANGLE’s assay in ongoing drug development.
While Eisai has opted not to advance BB-1701 development, returning product rights to BlissBio, the study is said to have strengthened its collaboration with ANGLE. Eisai has indicated interest in further projects that may benefit from Parsortix-based CTC analysis.
BlissBio has confirmed plans to continue BB-1701’s development independently. ANGLE is seeking to engage with the company for potential collaboration on future studies, although no formal agreements have been established.
