We returned VBL Therapeutics' (VBLT:NASDAQ) rating to "Market Outperform" recently, after lowering it in Q1/15 because of a failure in the company's inflammatory program.
Our "Market Outperform" rating is based on VB-111, a viral, vector-based, tumor necrosis factor (TNF) smart bomb that tracks to the vasculature in the tumor. It is designed for glioblastoma.
VBL is approaching a very interesting time. Updated data presented at the European Society for Medical Oncology Conference suggests that the improved survival rates it has seen are the direct result of VB-111.
Glioblastoma--and particularly relapsed glioblastoma--is a deadly disease. The type of patients who participate in the VBL trial would be expected to survive only a very brief time, yet many are surviving 16 to 18 months. Therefore, it appears VB-111 has a very real effect.
Updated data will be presented in October at the 15th International Thyroid Congress in Florida. In November, additional data to be presented at the Society for Neuro-Oncology meeting will compare the results of the angiogenesis inhibitor Avastin (bevacizumab; Genentech/Roche Holding AG [RHHBY:OTCQX]) to results achieved from combining Avastin with VB-111. That, I believe, will drive home the message that the benefit is coming from the addition of VB-111 on top of Avastin.
In early 2016, the company plans to petition the FDA to submit regulatory filings based on data it will have to date, and to use the ongoing Phase 3 trial as supportive data for full approval. While I think the chances of that occurring are fairly low, if it does happen, it would be a big upside surprise for VBL. It could enable VBL to shave a year off its launch estimate, which currently is expected in 2018.
