VBL Announces Patient Dosing of Recurrent Glioblastoma Multiforme Trial

VBL Therapeutics announced patient dosing has been initiated in a Phase 2 clinical trial investigating ofranergene obadenovec (VB-111) for the treatment of recurrent glioblastoma multiforme (rGBM). The study is sponsored by Dana-Farber Cancer Institute and is being conducted through a collaboration between VBL and seven leading neuro-oncology medical centers in the U.S.

“This new study builds upon our previous successful Phase 2 trial of VB-111 in recurrent glioblastoma (rGBM) while incorporating lessons learned from the GLOBE study,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “It will use the same VB-111 treatment regimen that induced significant survival benefit in our prior Phase 2 study, this time in patients that go through a second tumor resection. I believe that our perseverance could lead to renewed hope for rGBM patients who are in desperate need of therapies that may change their disease course and prolong life."

The Phase 2 study is enrolling patients with rGBM who are scheduled to undergo a second surgery. VB-111 will be administered either before and after surgery (neo-adjuvant and adjuvant therapy) or after surgery only (adjuvant therapy) and each arm will be compared to a standard of care control arm. In addition to endpoints of progression-free survival (PFS) at 6 months and overall survival (OS), collection of tumor specimens will allow important analysis of the activity of VB-111 within the tumor and will evaluate its effect on the immune system in this immunologically `cold` tumor.

VB-111 is an investigational, first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that uses a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. 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. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the U.S. and Europe, and fast track designation in the U.S. for prolongation of survival in patients with rGBM.