VBL Therapeutics Announces Publication of Phase 2 and Phase 3 Data of VB-111 in Recurrent Glioblastoma Supporting Continued Development in Investigator-Sponsored Study
TEL AVIV, Israel, Jan. 08, 2020 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced the publication of clinical data from the Phase 2 and Phase 3 studies of VB-111 (ofranergene obadenovec) in recurrent glioblastoma (rGBM) in two manuscripts published in the peer-reviewed journal Neuro-Oncology, the official journal of the Society for Neuro-Oncology.
In the Phase 2 study, patients with rGBM who were primed with VB-111 monotherapy that was continued after progression with the addition of bevacizumab (Avastin®) showed significant survival (414 vs 223 days; HR 0.48; p=0.043) and progression free survival (PFS) advantage (90 vs 60 days; HR 0.36; p=0.032) compared to a cohort of patients that had limited exposure to VB-111 (see manuscript by Brenner et al). Radiographic responders to VB-111 exhibited specific imaging characteristics related to its mechanism of action. Survival advantage was also seen in comparison to historic controls, with the percentage of patients living more than one year doubling from 24% to 57%.
The GLOBE Phase 3 study, top-line data from which were announced in 2018, compared upfront concomitant administration of VB-111, without priming, and bevacizumab to bevacizumab monotherapy. In this modified regimen, the treatment did not improve overall survival (OS) and PFS outcomes in rGBM. The new manuscript by Cloughesy et al. attributes the contradictory outcomes between the Phase 2 and Phase 3 trials as being related to the lack of VB-111 monotherapy priming in the GLOBE study, providing clinical, mechanistic and radiographic support for this hypothesis. Notably, GLOBE data show improved outcomes associated with a post VB-111 fever reaction, similar to outcomes from previous VB-111 studies, providing further support that fever is a potential biomarker for better survival with VB-111, secondary to the drug’s immunologic mechanism of action.
“The emerging picture from the Phase 2 and Phase 3 trials points to study regimen as a key factor for ofranergene obadenovec efficacy in rGBM,” said Patrick Wen, M.D., Director, Center for Neuro-Oncology at Dana-Farber Cancer Institute, Boston, MA, and a key investigator in both clinical trials. “These results warrant further assessment of ofranergene obadenovec, which we intend to advance in a new randomized, controlled, clinical trial in patients with rGBM undergoing a second surgery.”
Details on the new investigator-sponsored Phase 2 trial of VB-111 in rGBM were recently presented at the 2019 Society for Neuro-Oncology Annual Meeting (see link). An investigational new drug application for the new study has already gone into effect with the FDA and study launch is expected in early 2020. VB-111 is also being investigated in a Phase 3 pivotal study in ovarian cancer with interim data expected in the first quarter of 2020.
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. VBL’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. It is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a Phase 3 potential registration trial for platinum-resistant ovarian cancer.
Forward Looking Statements
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