On November 21, 2019 VBL Therapeutics (Nasdaq: VBLT) reported that data on the new investigator-sponsored Phase 2 study of VB-111 in recurrent glioblastoma (rGBM) will be presented by Timothy Cloughesy, M.D., Director and Professor, UCLA Neuro-Oncology Program at the 2019 Society for Neuro-Oncology (SNO) annual meeting, being held November 20-24, 2019 in Phoenix, Arizona (Press release, VBL Therapeutics, NOV 21, 2019, View Source [SID1234551579]).
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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: Dana-Farber Cancer Institute, Boston, MA (DFCI; study sponsor); Massachusetts General Hospital (MGH), Boston, MA; University of California, Los Angeles, CA (UCLA); University of California, San Francisco, CA (UCSF); Memorial Sloan Kettering, New York, NY; University of Utah, Salt Lake City, UT; and University of Texas, San Antonio, TX.
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."
Presentation details:
Abstract #: ATIM-09
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
Location: Ballroom Lawn