The pilot study’s success could lead to multiple large-scale follow-up studies. Credit: maleni ferrari from Pixabay.

Liquid biopsy company Angle and global pharmaceutical company Eisai have signed a contract for a pilot study involving the former’s Portrait human epidermal growth factor receptor 2 (HER2) assay.  

The study will be part of a Phase II clinical trial of HER2 targeting antibody-drug conjugate (ADC) BB-1701, focusing on breast cancer patients. 

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Under the agreement, Angle will receive $250,000 to provide circulating tumour cell (CTC) analysis with its assay to assess the HER2 status of these patients.  

The success of this pilot study could lead to multiple large-scale follow-up studies. 

Angle’s Portrait HER2 assay is designed to quantitatively assess HER2 protein expression and HER2/neu gene amplification. This dual assessment is essential for identifying patients who may benefit from anti-HER2 ADC treatments.  

It allows for the accurate stratification of patient populations based on HER2 status, which can vary over time. This capability is increasingly important as the market expands to include HER2-low patients. 

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Angle CEO Andrew Newland said: “The use of CTC biomarkers in clinical trials is a rapidly growing field enabling longitudinal monitoring of genomic, transcriptomic and proteomic changes.  

“Angle’s Portrait HER2 assay provides a way to evaluate HER2 status in patients where a tissue biopsy at the metastatic site either fails or is not feasible. We are delighted that Eisai is utilising our new HER2 assay for this study and believe that a successful pilot study will lead the way to a major expansion of this line of our business going forward.” 

With HER2-low breast cancer representing 55% of all breast cancer cases, the market for HER2+ breast cancer ADCs is expected to grow, reaching an estimated $3.3bn annually by 2030.