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MimiVax to Begin Phase II Study of Immunotherapy Vaccine in Glioblastoma

NEW YORK – MimiVax on Monday said it would begin a Phase IIb trial of its immunotherapeutic vaccine SurVaxM in newly diagnosed glioblastoma.

The randomized, blinded, placebo-controlled study will compare the standard-of-care chemotherapy for glioblastoma, temozolomide, with or without the SurVaxM. The primary endpoint is overall survival, and the researchers will also evaluate molecular predictors of response, including MGMT methylation status, IDH1 mutation, and survivin-specific responses.

SurVaxM was developed by researchers at Roswell Park Cancer Institute and targets survivin, a cell-survival protein present in glioblastoma and other cancers, including multiple myeloma, melanoma, ovarian, renal, lymphoma, prostate, and breast cancers. The therapy identifies survivin-expressing cancer cells and stimulates the patient's immune system to attack those cells. MimiVax was spun off from Roswell Park in 2012 to develop this product.

In a Phase IIa trial of SurVaxM plus chemo in glioblastoma, the median overall survival was 25.8 months compared to the expected overall survival of 16 months for chemotherapy alone. MimiVax, based in Buffalo, New York, is also studying SurVaxM to treat recurrent or progressive malignant glioma, neuroendocrine tumors, and as a maintenance therapy in multiple myeloma.