VBL Therapeutics, a clinical stage biopharmaceutical company, has enrolled first patient in its phase 3 pivotal registration trial, OVAL, studying its lead candidate VB-111 (ofranergene obadenovec) in platinum-resistant ovarian cancer.

The OVAL study will be conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation, Inc., a leading organization for research excellence in the field of gynecologic malignancies.

“There is a tremendous need for effective treatments for women with platinum resistant and refractory ovarian cancer, estimated at 50,000 cases in the United States, for whom therapeutic options often fail to prolong survival. We are excited to be working with the GOG, a standard-setting organization for clinical research on pelvic malignancies, in addressing this important medical need," said Dror Harats, MD, chief executive officer of VBL Therapeutics.

"GOG is an organization dedicated to clinical research in the field of gynecologic cancer. Interest in the VB-111 development program is based on positive clinical data generated using this agent, including the phase 2 study that VBL completed in ovarian cancer, which showed a high response rate and better survival with the therapeutic dose of VB-111," said Richard Penson, MD, MRCP, associate professor of Medicine, Harvard Medical School, clinical director of Medical Gynecologic Oncology, Massachusetts General Hospital, Primary Investigator for the VB-111 Phase 2 trial and the Principal Investigator of the new OVAL study.

In December 2016, VBL held an End-of-phase 2 meeting with the US Food and Drug Administration (FDA) to discuss the clinical path forward for VB-111 in ovarian cancer. The company has reached an agreement with the agency on the VB-111 phase 3 pivotal study in platinum-resistant patients, with overall survival as the primary endpoint.

The randomized, controlled, phase 3 OVAL study in recurrent platinum-resistant ovarian cancer has been designed to enroll up to 350 adult patients at approximately 70 clinical sites in the United States and Israel. Patients will be randomized 1:1 to VB-111 in combination with chemotherapy, or chemotherapy alone. The primary endpoint is overall survival. Additional endpoints include objective response rate (ORR), progression free survival (PFS), combined CA-125 and RECIST 1.1 response (GCIG criteria) and patient reported outcome measures.

At the 2016 ASCO, the company presented data in platinum-resistant ovarian cancer, demonstrating a meaningful and significant increase in overall survival with VB-111 given in combination with chemotherapy (810 days vs. 172 days, p=0.042), along with a 60% durable CA-125 response rate—approximately two times the historical response observed with bevacizumab (Avastin) plus chemotherapy in ovarian cancer.

VB-111 is also being studied in the GLOBE phase 3 pivotal trial for recurrent glioblastoma (rGBM), conducted under an FDA Special Protocol Assessment (SPA), with top-line data expected in the first quarter of 2018.

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 cancer.