OracleBio has performed numerous histology image analysis studies to support clinical oncology R&D trials. This has included a range of different analysis, from quantifying distinct morphological features within oncology tissue based on viable tumor, stroma and necrotic content through to detailed changes in specific immune /inflammatory cell populations, drug response biomarkers and target related intracellular proteins. The data have helped our Clients better interpret the PKPD relationship of their therapy though demonstration of target engagement within tumor tissue, while also generating supportive evidence for the mechanism of action of their therapy.
Although all of our studies are performed under strict confidentiality, we were delighted to be recently acknowledged by one of our Clients for our histopathology image analysis work performed for their clinical trial oncology study, which was subsequently published in ‘The Lancet’ in November 2015. This Phase 2b study, performed by US based Inovio Pharmaceuticals, evaluated the safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia (CIN) 2/3.
The primary efficacy endpoint was Pathologist assessment for regression of cervical neoplasia to CIN1 or normal pathology 36 weeks after the first dose. Secondary read-outs included digital image analysis quantification of immunohistochemistry (IHC) stained immune cells and biomarkers within collected cervical tissue samples. All image analysis was performed by OracleBio using Definiens Tissue Studio®. In order to achieve this, the Client’s Pathologist digitally annotated specific regions of interest (ROI) onto each IHC stained tissue section whole slide image. Annotation vector files per image were then sent to OracleBio and imported into Tissue Studio along with their respective IHC image. We then developed customised algorithms within Tissue Studio for quantification IHC staining per marker specifically within the Pathologist annotated ROI.
The example analysis below shows detection of CD8+ T-cells within Pathologist annotated ROI. Image analysis data generated as part of this study supported the interpretation of the positive therapeutic response of VGX-3100 observed in the trial.
More details on the study, published by Trimble et al., including data generated via histology image analysis (supplements section) can be found at ‘The Lancet’. If you would like more information on how OracleBio can help quantify histologically stained markers as part of your clinical oncology study please contact us or email us at firstname.lastname@example.org.