New Biomarker Data Supports Direct Link between VB-111’s Dual Mechanism of Action and its Clinical Effect on Overall Survival and Progression Free Survival in Recurrent Glioblastoma Multiforme Patients
These new findings, which were recently presented in an oral presentation at the 22nd Annual Meeting of the
“These promising biomarker data correlate increased tumor blood vessels and inflammatory markers with increased survival benefit. This understanding is a critical step in patient care and clinical decision-making as biomarkers have the potential to guide treatment and predict patient response and benefit from therapies,” stated
Summary of Data
The purpose of this analysis was to characterize vascular imaging parameters and the release of immuno-stimulatory cytokines, and to explore their correlation with the survival benefit observed in this trial.
- VB-111 demonstrated a significant improvement in PFS and OS in a Phase 2 trial in rGBM.
- Febrile response to VB-111 treatment was an indicator of immune activation which was a predictor of increased OS.
- Improved OS in VB-111-treated patients correlates with vascular imaging parameters.
- Improved OS in VB-111 treated patients correlates with an immune-stimulatory cytokine response.
- VB-111 promotes secretion of pro-inflammatory, anti-tumor immune mediators and reduces T-cell production of immuno-suppressing cytokines in a preclinical GBM model.
“Our latest analysis has further strengthened our understanding of the highly novel dual mechanism of action of VB-111,” said Dror Harats, MD, CEO of VBL Therapeutics. “We have shown that the survival benefits observed in our rGBM Phase 2 trial are tied to reduced tumor vascularity, which is consistent with what we know about the anti-angiogenic properties of VB-111. In addition, we have demonstrated that VB-111 is associated with fever and immune-mediated responses, including secretion of immune-stimulatory cytokines that correlate with OS as well. The dual mechanism of action is further supported by preclinical data identifying the cell populations and molecular signaling driving this immune anti-tumor response. The data also provide new potential biomarkers that may be useful for clinical analyses. Building upon this, we look forward to additional insights on VB-111 from our pivotal Phase 3 GLOBE trial in rGBM, from which we expect top-line data in the first quarter of 2018.”
About VB-111 (ofranergene obadenovec)
Lead candidate VB-111 is a first-in-class anticancer targeted gene therapy-based biologic that has demonstrated statistically significant long-term survival in patients and offers broad potential to treat a wide range of cancers. VB-111 harnesses natural processes in the body to target tumors by employing a dual mechanism – a proprietary anti-angiogenic gene therapy that leads to targeted elimination of the tumor’s blood supply, and a viral immuno-oncology mechanism that educates the immune system to fight the tumor. VB-111 is currently being studied in a Phase 3 pivotal trial for rGBM under a special protocol assessment (SPA) with the
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding VB-111, including its clinical development, therapeutic potential and clinical results, including the expected timing of clinical results and the initiation of clinical trials. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our pivotal Phase 3 clinical trial of VB-111 in rGBM may not support approval of VB-111 for marketing in the
Matt Middleman, M.D.
LifeSci Public Relations