MVI uniquely distinguishes itself from most biotechnology vaccine companies in the prostate cancer space based on the number of completed and ongoing clinical trials, coverage across multiple stages of the disease, and combinations with multiple agents.
MVI DNA plasmids have demonstrated very strong safety and tolerability in our human trials. This has two important consequences:
MVI is committed to exploring use of our plasmids in combinations across the prostate cancer disease spectrum.
We have run trials in early stage non-metastatic prostate cancer, during early therapy for metastatic prostate cancer, and during the later stages of castration-resistant metastatic prostate cancer.
The critical assumptions underlying MVI technology are that immunization with plasmid DNA is a competent means to elicit Th1/CTL-biased immune responses in humans, and that vaccination will be most efficacious if used in the minimal residual disease setting, before overt metastases can be detected by standard imaging technologies.
The critical clinical rationale for MVI vaccines is that induction of a productive CTL response will result in significant delay in progression to overt metastases and initiation of castration therapies for men with non-metastatic prostate cancer, and prolonged duration of disease control in patients already receiving ADT and/or second generation AR inhibitors in the case of the AR vaccine, thereby providing clinically meaningful benefit, and significantly improving quality of life for prostate cancer patients.