VBL Therapeutics Announces Patient Dosing Initiated in Randomized, Controlled and Blinded Trial of VB-111 in Patients with Recurrent Glioblastoma Multiforme
- Category: DNA RNA and Cells
- Published on Monday, 01 March 2021 18:02
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Investigator-sponsored study will be conducted at seven centers in the U.S.
TEL AVIV, Israel I March 01, 2021 I VBL Therapeutics (Nasdaq: VBLT) today announced that 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. Additional information about the new VB-111 study can be found on ClinicalTrials.gov (NCT04406272).
About VB-111 (ofranergene obadenovec)
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. VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer (NCT01229865) and recurrent platinum-resistant ovarian cancer (NCT01711970).
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for areas of unmet need in cancer and immune/inflammatory indications. VBL has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related indications. VBL’s lead oncology product candidate, ofranergene obadenovec (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 currently being studied in a VBL-sponsored Phase 3 potential registration trial for platinum-resistant ovarian cancer.
SOURCE: VBL Therapeutics