On April 21, 2020 VBL Therapeutics (Nasdaq: VBLT) reported that it has been awarded a non-dilutive grant of up to 3.175 million New Israeli Shekels (NIS) (approximately $0.9 million) by the Israel Innovation Authority (IIA) (Press release, VBL Therapeutics, APR 21, 2020, View Source [SID1234556453]). The IIA has approved a budget of approximately $1.8 million for the VB-111 project during 2020, with 50% of this amount as an IIA grant. The funds will support the continued development of VBL’s lead product candidate, VB-111, a first-in-class targeted anti-cancer gene-therapy agent. VB-111 is currently being evaluated in a Phase 3 potential registration study (OVAL) for the treatment of platinum-resistant ovarian cancer.
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On March 26, 2020, VBL announced a positive outcome in the first interim analysis in the OVAL study, demonstrating an absolute percentage advantage of 10% or higher CA-125 response rate for the VB-111 treatment arm. According to the interim data, the response rate in the treatment arm was 58% or higher. In patients with post-treatment fever, the CA-125 response was 69%. Fever is frequently observed after VB-111 treatment. The CA-125 response rate observed in the Phase 3 interim analysis is at least as good as the response rate seen in the successful Phase 2 trial, which enrolled a similar population of patients with platinum-resistant ovarian cancer and showed overall survival benefit.
"We thank the IIA for their continued support and external validation of our VB-111 program, which continues to demonstrate encouraging clinical data in ovarian cancer, as well as in additional solid tumor indications," said Prof. Dror Harats, Chief Executive Officer of VBL Therapeutics. "Our OVAL Phase 3 study continues to recruit patients and we expect our next interim analysis to occur in the fourth quarter of 2020, as planned."
About VB-111 (ofranergene obadenovec)
VB-111 is a 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).