On November 6, 2019 VBL Therapeutics (Nasdaq: VBLT) reported that an investigational new drug (IND) application has received clearance from the U.S. Food and Drug Administration (FDA) (Press release, VBL Therapeutics, NOV 6, 2019, View Source [SID1234550558]). The IND is for a Phase 2 randomized, controlled, clinical trial of VB-111 in rGBM patients undergoing a second surgery. In this new study, VB-111 will be administrated either before and after the surgery (neo-adjuvant and adjuvant therapy) or just after the surgery (adjuvant therapy) and will be compared to a standard of care control cohort. The IND was submitted by Patrick Wen, M.D., Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, on behalf of a group of top neuro-oncology US medical centers.

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"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 Timothy Cloughesy, M.D., Director and Professor, UCLA Neuro-Oncology Program and a co-principal investigator of the upcoming study.

A prior Phase 2 study demonstrated a survival benefit for patients with rGBM primed with VB-111 monotherapy that was continued upon progression with a combination of VB-111 and bevacizumab. The primary endpoint of this new study in participants with surgically accessible rGBM is to investigate whether administration of VB-111 as a neo-adjuvant treatment prior to surgery can result in an increase in tumor infiltrating T lymphocyte (TIL) within the tumor and enhance systemic tumor-specific T cell responses. Secondary endpoints will include progression free survival at 6 months (PFS-6) and overall survival (OS).

"This study builds upon our previous positive Phase 2 trial of VB-111 in rGBM and it incorporates lessons learned from the GLOBE study, aiming to optimize the regimen for VB-111 in this deadly tumor," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We look forward to exploring the potential of neo-adjuvant treatment with VB-111 to turn immunologically ‘cold’ GBM tumors ‘hot’."

Additional details about the study will be presented at the 2019 Society for Neuro-Oncology annual meeting, to be held on November 20 – 24, 2019 in Phoenix, Arizona.