This translational and industrial program aims at positioning an innovative immunmodulatory agent, an improved and recombinant fusion IL-15 protein called CYP0150, to treat cancers in the best conditions. Based on a strong basis of relevant in vivo models (human immune system mouse, primates) and ex vivo tumor biopsies, we intend to validate the toxicology/pharmacology/immunogenicity ratio of this new drug to consolidate our regulatory preclinical studies. Moreover, thanks to many emerging and revolutionary concepts demonstrating the critical role of the immune system on the efficacy of many anticancer drug classes, several therapy combinations will be evaluated to leverage the pharmacological effects of RLI as best as possible and to define the best treatment combinations to be used in phase II clinical trials. Last but not least, specific molecules related to the IL-15/IL-15Ralpha transpresentation system will be monitored in cancer patient samples before and after therapy to define a relevant biomarker useful to predict and select the best-responsive patient populations for a CYP0150-based therapy as stand-alone or in combination with other anticancer drug classes. Based on the internal regulatory preclinical development of CYP0150 and this translational collaborative program, we should be able to initiate our clinical trials in cancer patients by early-2013 in optimal conditions and to consolidate our worldwide leadership position in this IL-15-related field.