FDA grants fast track designation to vaccine-enhanced cell therapy for glioblastoma
The FDA granted fast track designation to TVI-Brain-1, an adoptive T cell therapy for the treatment of glioblastoma multiforme, according to the agent’s manufacturer.
TVI-Brain-1 (TVAX Biomedical) is an autologous, vaccine-enhanced adoptive T-cell therapy comprising a proprietary vaccine pretreatment to generate cancer-specific T cells and an activated antitumor T-cell treatment.
The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
“We are very pleased to receive fast track designation by the FDA for glioblastoma multiforme,” Wayne Carter, DVM, PhD, CEO of TVAX Biomedical, said in a company-issued press release. “Glioblastoma is a terrible disease for which there are limited clinical options.”
The FDA based the fast track designation on results of phase 1 and phase 2 studies of TVAX immunotherapy, which has demonstrated significantly increased median survival compared with historical controls, according to the manufacturer.
TVAX plans to start enrollment later this year for a phase 2b study among patients with newly diagnosed glioblastoma multiforme, according to the press release.