Solid tumor gene therapy! VBL's first anti-cancer gene therapy VB-111 to treat platinum-resistant ovarian cancer shows strong results!

August 16, 2020 // -- The Israeli gene therapy company VBL Therapeutics recently announced that the Independent Data Monitoring Committee (DSMC) has completed its second pre-planned interim analysis of its ongoing OVOAL III study.
the study is evaluating gene therapy VB-111 (ofranergene obadenovec) for the treatment of platinum-resistant ovarian cancer.
DSMC members unanimously recommended that the study continue as planned.
in its second interim analysis, DSMC reviewed data on the total non-blind lifetime (OS) of the first 100 randomized patients who followed for at least three months, which was the main endpoint of the OVAL study.
DSMC also reviewed mitigation rates and security information. Dr. Dror Harats, chief executive of
VBL, said, "We are pleased that DSMC has recommended that the OVAL study continue as planned, the second successful interim analysis of the OVAL study, reviewing the non-blind overall survival data for VB-111 and placebo.
Despite the COVID-19 pandemic, OVEL studies continue to show very strong patient recruitment rates, and we are very encouraged by the high mitigation rate of more than 50 percent of the participants in the trial, which has remained the same.
this latest DSMC recommendation, together with the significant mitigation rates we observed in the first interim efficacy analysis and the survival benefits of VB-111 in Phase 2 trials in patients with platinum-resistant ovarian cancer, supports our confidence in OBAL.
we are pleased to bring potential benefits to ovarian cancer patients.
" OVAL study is an international Phase 3 randomized key potentially registered clinical study comparing the efficacy of VB-111 in the treatment of platinum-resistant ovarian cancer patients with VB-111 combined with yew alcohol and placebo combined with yew alcohol.
the study was planned to include about 400 patients.
, VBL released its first interim analysis.
reviewed non-blind data measured according to GCIG standards and assessed CA-125 responses in the first 60 patients in the group who could be analyzed for CA-125 protein.
CA-125 protein in the blood is a specific marker of ovarian cancer.
analysis showed that the total remission rate (ORR) was 53% in patients with CA-125 protein levels in the first 60 assessable patients.
hypothesized balanced random grouping, the ORR in the treatment group (VB-111 combined with yew alcohol) was 58% or higher.
patients who developed fever symptoms (a marker of VB-111 treatment) after treatment, the ORR was 69%.
VB-111 dual-acting mechanism (click on the image: see the graph) VB-111 is a pioneering "first-in-class" targeted anti-cancer gene therapy that is being developed for the treatment of multiple solid tumors.
VB-111 is a unique biological agent that uses a dual mechanism to target solid tumors - blocking the tumor vascular system and stimulating an anti-tumor immune response, with the result that: (1) starving the tumor;
VB-111 is an adenovirus gene therapy that is administered intravenously every 6-8 weeks and expresses an anti-tumor necrosis group 1 (TNFR1) and Fas on vascular endotrine cells in tumor tissue The fusion protein, which can cause endotrine apoptosis of blood vessels, inhibit tumor angiogenes, cause tumor cell death and release tumor-specific new antigens, while adenovirus, as an immune adverb, can promote tumor T-cell immersion, the tumor from cold to hot.
these two mechanisms produce a strong anti-tumor immune response.
VB-111 was observed in more than 300 cancer patients and showed signs of activity in an open-ended cancer-type Phase I trial and three tumor-specific Phase II trials.
VB-111 has been granted ODD status in both the United States and the European Union, as well as fast track eligibility (BTD) for the treatment of rGBM patients in the United States.
addition, VB-111 successfully demonstrated proof-of-concept and survival benefits in phase II clinical trials of radioactive iodine-resistant thyroid cancer and recurring platinum-resistant ovarian cancer.
Origin: VBL Therapeutics Announcs Second Successful Pre-planned In Analysis with a Positive Safety Data Monitoring Committee Review Review At OS - The Primary Endpoint of the OVAL Phase 3 Potential Registration Study of VB-111 in Ovarian Cancer.