TVI-Brain-1 for the Treatment of Glioblastoma
Our lead product candidate, TVI-Brain-1, is being evaluated for the treatment of Glioblastoma (a form of brain cancer) and is supported by positive Phase 2 clinical data, as well as extensive preclinical and Phase 1 safety studies.
TVAX Biomedical has received FDA Fast Track Designation for the use of this vaccine-enhanced adoptive T cell therapy for treatment of glioblastoma multiforme. Read More…
The company has also received an approximately $2 million 4-year grant from the FDA Office of Orphan Products for its planned glioblastoma study. Read More..
Clinical Trial for Brain Cancer
TVAX initiated a Phase 2b study in newly diagnosed surgically resectable MGMT unmethylated (O6-methylguanine methyltransferase negative) glioblastoma patients in 2023. The clinical study is being conducted at academic and corporate hospital clinical sites around the US.
Clinical Data for TVI-Brain-1
TVAX Immunotherapy® has been evaluated in Phase 1/2 clinical trials in 43 patients with recurrent grade 3 and grade 4 gliomas who previously failed surgery, radiotherapy and chemotherapy. Results of these studies demonstrated significantly increased median survival for patients treated with TVAX Immunotherapy as compared to historical controls.