Pre-clinical models have demonstrated unequivocal progress in generating increasingly potent vaccine strategies that creatively exploit new pathways governing immune regulation. A major limitation to an approved vaccine has been that most have been studied as single agents in heavily pre-treated patients harboring advanced tumor burdens. Although the safety profile has been found to be remarkably favorable, there is growing consensus that for cancer vaccines to have a clinically meaningful impact, the paradigm must change. Our group seeks to move cancer vaccines into clinical settings that meet several criteria: 1) currently available therapies can reduce the bulk of the cancer without suppressing the host immune system; 2) such therapies themselves create a favorable setting for active immunization; 3) sensitive markers of disease burden exist to give a rapid readout of disease response; and 4) immune responses can be quantified to enable the correlation of vaccine effects with changes in tumor burden. In this proposal, the immuno-gene therapy of MDS represents an opportunity that these criteria, maximizing the probability that a clinically meaningful impact may be observed.


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