VBL Therapeutics to Present Data on New Investigator-Sponsored Phase 2 Trial of VB-111 in Recurrent Glioblastoma at the 2019 Society for Neuro-Oncology Annual Meeting
The randomized, controlled clinical trial will study VB-111 in rGBM patients undergoing a second surgery. VB-111 will be administrated either before ('neo-adjuvant') and after the surgery ('adjuvant'), or just after the surgery, and will be compared to a third cohort that will receive standard of care as control. The trial will be conducted at seven top neuro-oncology US centers:
The primary endpoint of this new study is an immunological readout, which is to investigate whether administration of VB-111 prior to surgery can result in an increase in tumor infiltrating T lymphocyte (TIL) within the rGBM tumor. Secondary endpoints include progression free survival at 6 months (PFS-6) and overall survival (OS). Planned enrollment is 45 patients, randomized evenly across three groups.
“MRI analysis conducted at UCLA of the VB-111 Phase 2 and GLOBE Phase 3 studies demonstrated objective responses to VB-111 monotherapy. Importantly, VB-111 responders had a survival advantage. These clinically meaningful findings suggest that VB-111 should be furthered explored in rGBM,” said Dr. Cloughesy, a co-principal investigator of the study.
“This important investigator-sponsored study will provide further information on the therapeutic potential of VB-111 in rGBM when administered as monotherapy,” said Tami Rachmilewitz, M.D., Vice President Clinical Development of VBL Therapeutics. “The study is intentionally designed as a randomized, controlled, blinded trial to generate results that can be part of a future filing with the regulatory authorities. We thank the key opinion leaders in the glioblastoma field for pursuing the potential of VB-111 for the benefit of patients in this deadly disease.”
|Abstract Title:||Clinical trial in progress: A study of neoadjuvant and adjuvant VB-111 for treatment of recurrent GBM|
|Date:||Saturday November 23, 2019|
|Presentation Time:||5:00 PM – 7:00 PM MST|
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 our programs, including VB-111, including their clinical development, such as the timing of clinical trials and expected announcement of data, therapeutic potential and clinical results, and our financial position and cash runway. 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, the risk that historical clinical trial results may not be predictive of future trial results, that our financial resources do not last for as long as anticipated, and that we may not realize the expected benefits of our intellectual property protection. A further list and description of these risks, uncertainties and other risks can be found in our regulatory filings with the