MimiVax is developing SurVaxM, a novel cancer immunotherapeutic designed to stimulate a multi-faceted immune response targeting the tumor-specific antigen survivin. A multi-center, single-arm phase 2 clinical trial of SurVaxM in newly diagnosed glioblastoma (nGBM, NCT02455557) is now fully enrolled and data updated. Patients enrolled at 5 US cancer centers (n=63 patients) show a median time to tumor progression (mPFS) of 13.9 mos from diagnosis, Overall Survival at 12 mos was 93%, median OS has not been reached. A smaller phase 1 study in recurrent glioma showed 7 of 8 patients OS ranging from 1-6 years. Patient safety continues to be good. MimiVax is planning a phase 2 Randomized Controlled Trial (RCT) of SurVaxM in nGBM enrolling 240 patients at up to 20 US centers. FDA orphan disease designation was awarded for SurVaxM in 2017. MimiVax is active in partnering discussions and fundraising to support the development of SurVaxM in nGBM as well as many other survivin-expressing cancers.
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