SBIR PHASE II - TOPIC 396 - IMAGING FOR CANCER IMMUNOTHERAPIES

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Immunotherapy has transformed cancer treatment, but therapy response remains low for certain tumor types. Despite the vital significance of immune activity within tumors, there are currently no non-invasive immunomonitoring methods for assessment of immune contexture and assessment of response to therapy. To address this urgent need, Cellsight Technologies is developing a PET agent specific for activated T cells, [18F]F-AraG, as an imaging biomarker of immunotherapy response. In Phase I we demonstrated in preclinical models the ability of [18F]F-AraG to provide an early assessment of response to both mono and combinatorial immunotherapy. In Phase II we focus on optimization and standardization of clinical image analysis and quantitation as the crucial components of [18F]F-AraG’s suitability to serve as a biomarker of immunotherapy response. In this project, we will determine treatment-independent variability in lung cancer patients to accurately define a threshold that indicates therapy-induced signal changes. This threshold will be used for automated quantitative analysis of [18F]F-AraG scans and creation of response maps in lung cancer patients undergoing combinatorial immunotherapy. The results of the planned investigations will address some of the most critical issues in quantitative image analysis and strongly advance development of [18F]F-AraG as an imaging biomarker for response to immunotherapies.