On March 19, 2019 VBL Therapeutics (Nasdaq: VBLT), reported the presentation of human data indicating that the viral anti-cancer investigational therapy VB-111 has potential to stimulate the immune system to induce a strong and durable response against ovarian tumors (Press release, VBL Therapeutics, MAR 19, 2019, View Source [SID1234534461]). Administration of VB-111 was associated with an infiltration of immune cells within the tumor, which was followed by tumor necrosis and sustained clinical response. VBL’s study entitled "VB-111, an anti-cancer gene therapy, induces immunotherapeutic effect in platinum resistant ovarian cancer" was presented last evening at the SGO 50th Annual Meeting on Women’s Cancer at the Hawaii Convention Center in Honolulu, Hawaii. The presentation was delivered by Dr. Ronnie Shapira-Frommer from Sheba Medical Center, Tel Aviv and Dr. Richard Penson from Massachusetts General Hospital, Boston.
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Ofranergene obadenovec (VB-111) is a targeted anti-cancer investigational gene therapy with a dual mechanism: disruption of the tumor vasculature and induction of an anti-tumor directed immune response. In a Phase 2 clinical trial, VB-111 in combination with chemotherapy (paclitaxel) prolonged survival in patients with recurrent platinum resistant ovarian cancer (median OS 498 days for therapeutic dose VB-111 + paclitaxel combination therapy, compared to 172 days for low dose VB-111 + paclitaxel (p=0.03)). OVAL, VBL’s ongoing pivotal Phase 3 trial, is designed to repeat the successful Phase 2 protocol, with the primary endpoint of improvement in overall survival. An interim analysis of the OVAL study is expected at year-end 2019.
"Cancer cells utilize various mechanisms to proliferate and survive, including silencing of, and escape from, the immune system. We believe that treatment strategies should therefore aim both to target the cancer cells and to stimulate the immune system to attack the tumor," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "While we initially designed VB-111 as anti-tumor therapy targeting tumor blood supply, it is now evident that VB-111 can also drive immune cells into immunologically `cold` tumors turning the tumors ‘hot,` enabling the immune system to fight the tumor. These clinical findings provide encouraging evidence of the therapeutic potential of VB-111, as we continue to advance our clinical program in ovarian cancer and additional indications."
For a link to VBL’s poster at the SGO 50th Annual Meeting on Women’s Cancer refer to: SGO Poster
About Ofranergene Obadenovec (VB-111)
VB-111, a potential first-in-class anticancer therapeutic candidate, is the Company’s lead oncology product currently being studied in the OVAL potential-registration Phase 3 pivotal trial for ovarian cancer (ClinicalTrials.gov Identifier: NCT03398655). VB-111 has 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. In addition, 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). VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission.