MimiVax’ Brain Cancer Drug Gets FDA Approval for New Phase 2b Study

An accomplished financial professional with more than 20 years of experience, Marc David Broidy has served as a financial advisor with Smith Barney and vice president of Merrill Lynch. In addition, Marc Broidy has sat on the boards of directors of numerous organizations including MimiVax, a Buffalo, New York-based clinical-stage biotechnology company committed to improving the survival rate of patients with cancer.

In November 2021, MimiVax announced it had received a green light from the U.S. Food and Drug Administration (FDA) to start a Phase 2b clinical trial of its lead drug SurVaxM, an innovative patented peptide vaccine, in patients newly diagnosed with glioblastoma. Glioblastoma is among the deadliest yet most common adult brain cancers, and newly diagnosed cases present a pressing unmet medical need.

Titled SURVIVE, the clinical trial will encompass a randomized, blind, and placebo-controlled study across multiple centers and compare the current standard medication temozolomide alone to the drug in combination with SurVaxM. The initial enrollees include several US locations, but more sites in the country and in China are to follow.

According to its name, the trial’s primary goal is overall survival. In addition, it also aims at evaluating various biomarkers that predict response, such as MGMT methylation status and IDH1 mutation. Researchers have identified both as strong predictive factors of favorable survival in patients with glioblastoma.