On December 29, 2020 VBL Therapeutics (Nasdaq: VBLT) reported the expansion of its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer into Europe, where the first patient has now been enrolled (Press release, VBL Therapeutics, DEC 29, 2020, View Source [SID1234573310]). The study continues to actively recruit patients in the U.S. and Israel, with over 200 patients enrolled to date.
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"VB-111 is our proprietary anti-cancer gene therapy product candidate that has shown overall survival benefit across multiple tumor types," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We are pleased to expand the OVAL potential registration study of VB-111 in patients with late stage ovarian cancer to Europe, which is expected to accelerate our recruitment pace, diversify the patient population in the study and support our dialogue with European regulatory authorities as we get closer to potential commercialization. If successful and approved, VB-111 has the potential to establish a new standard of care in a challenging disease setting where patients currently have limited options."
Interim analysis from OVAL demonstrated VB-111’s significant response rate of 58% or higher in the first 60 patients. According to the Company update on November 16, 2020, the high response rate of >50% in the total evaluable patient population was still maintained with approximately 200 patients enrolled.
The EU expansion follows two completed analyses by the independent Data Safety Monitoring Committee (DSMC) which recommended to continue the study as planned. The next DSMC review is expected in the first quarter of 2021.
VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission.
About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal potential registration clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies.
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 US and Europe, and fast track designation in the US 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 and recurrent platinum-resistant ovarian cancer (NCT01711970).