This SBIR Phase II project is dedicated to complete development and validation of a new Microtumor culture/ assay system which allows robust cellular, molecular and drug efficacy analysis ex vivo. In Phase I, colon and glioma Microtumors were produced with high viability by using patient-derived cells (PDx) and patented 3D HuBiogel culture technology. Pilot data demonstrated human Microtumors, unlike cellular spheroids, exhibit heterotypic environment during long-term cultivation thus allowing precise functional and drug activity analysis. Vivo Biosciences' continued Phase II objectives are: 1) Validate Microtumor response to many clinical agents and compare efficacy profile with in vivo animal model; 2) Confirm biomarker, kinomic and transcriptomic profiles of PDx tumors via clinical data base/reports and 3) Establish high-throughput protocols for Microtumor analysis, automated imaging and efficient drug screening. A library of human tumor models (colon, brain) with differing drug response (sensitive, resistant) will be evaluated for preclinical or clinical drug efficacy endpoints. Vivo Biosciences anticipates new Microtumor system would offer practical benefits over tumor spheroid model and its predictive metrics for commercialization will be fully established. Vivo Biosciences is confident of successfully developing a marketable fully-human 3D tumor assay platform for academic, government and Pharma research programs. In future, individual tumor sample or biopsies can be tested for patient-specific drug or therapy response analysis using our advanced 3D tumor culture technology.
