On June 4, 2020 TVAX Biomedical reported that receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the use of its vaccine-enhanced adoptive T cell therapy (VACT) for treatment of glioblastoma multiforme, a deadly form of brain cancer (Press release, TVAX Biomedical, JUN 4, 2020, View Source [SID1234560853]).

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"We are very pleased to receive Fast Track Designation by the FDA for glioblastoma multiforme (GBM)," stated Dr. Wayne Carter, Chief Executive Officer. "Glioblastoma is a devastating disease for which there are limited treatment options."

FDA Fast Track Designation is designed to accelerate marketing approval of therapies aimed at treating serious and life-threatening diseases. The Designation creates an opportunity for close and regular communication between TVAX Biomedical and the FDA in order to improve the efficiency of product development. Additionally, it provides a pathway for accelerated approval and rolling review of completed Biological Licensing Application sections by the FDA.

TVAX Biomedical has completed Phase 1 and 2a studies in multiple cancers, including GBM. Significant benefit was demonstrated in GBM patients using TVAX’s patented VACT in those studies. TVAX’s currently planned studies will evaluate VACT in newly diagnosed GBM patients who have healthy immune systems and minimal disease at a time when VACT would be anticipated to generate maximal efficacy.