BACKGROUND
- F-06647020, an ADC comprising a humanized monoclonal antibody against PTK7, a cleavable valine-citrulline linker, and an auristatin payload, is being investigated in an ongoing Phase I clinical trial in patients with advanced solid tumors.
- We hypothesized that response to a PTK7-directed ADC would correlate with PTK7 expression in the patients’ tumor.
APPROACH
- We developed and validated a novel LDT comprising an anti-PTK7 immunohistochemistry assay with digital tissue analysis using Flagship Biosciences, Inc.’s cTA® platform to detect membrane-associated PTK7 in formalin-fixed paraffin embedded (FFPE) epithelial malignancies of ovary, breast and lung.
CONCLUSIONS
- A novel CLIA validated LDT was developed and implemented to assess PTK7 baseline levels in FFPE tumors from patients treated with PF-06647020.
- Clinical responses tended to correlate with H-scores that were higher than the mean for each tumor type.