VBL Therapeutics has secured fast track status from the US Food and Drug Administration (FDA) for its lead oncology drug VB-111, for prolongation of survival in patients with Recurrent Glioblastoma Multiforme (rGBM).
VB-111 was already granted orphan drug status in the US and Europe for GBM, an aggressive form of brain cancer that carries a very poor prognosis with the existing therapy.
The drug, which is given as a simple IV infusion, is a novel gene-therapy that targets endothelial cells in the tumour vasculature, acting as a biological knife.
Based on a non-replicating adenoviral vector, the drug harbours a proprietary promoter which regulates transcription of a Fas-Chimera transgene, leading to targeted cell-death of endothelial cells in tumor-feeding blood vessels, with no harm to normal vasculature and non-cancerous tissues in the body.
VB-111 is claimed to be the first agent based on transcriptional targeting of tumour endothelium to be assessed in a clinical trial.
The company said that in the recently released Phase I/II trial results, VB-111 showed safety and tolerability in patients with advanced metastatic cancer at a single administration.
During the trial, tumour response and superior overall survival were found in the 1x1013 VPs cohort compared to sub-therapeutic doses.
Apart from GBM, VB-111 is also assessed in multi-dose Phase II clinical trials for differentiated thyroid cancer and ovarian cancer.
