Date: 2017-10-16
Type of information: Granting of the orphan status in the EU
Product name: VB-111
Compound: ofranergene obadenovec
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism:
- gene therapy. VB-111 is a dual-action, anti-angiogenic and Vascular Disruptive Agent (VDA) that utilizes VTS™, VBL’s proprietary platform technology for cancer therapy. VB-111 is an intravenously administered VDA that works in a manner akin to a “biological knife” to destroy tumor vasculature, thus cutting off the blood vessels feeding the tumor. Preclinical pharmacological and toxicology studies of VB-111 showed tissue specificity for the tumor tissue, no significant damage to normal non-cancerous tissues or to the normal vasculatures in the body, and a more than 90 percent reduction in metastatic lung cancer model with one injection, as well as similar efficacy in other tumor models. A Phase 1 “all-comers” study of VB-111 in 33 patients with advanced metastatic cancer demonstrated antitumor activity and no effects on liver function or major changes in complete blood count.
Company: VBL Therapeutics (Israel)
Disease: ovarian cancer
Latest news:
- • On October 16, 2017, the European Medicines Agency (EMA) has designated ofranergene obadenovec (VB-111) as an “orphan medicinal product” for the treatment of ovarian cancer, adding to the orphan status already granted for glioblastoma in US and Europe. VB-111 is the Company’s lead product candidate currently being studied in a Phase 3 pivotal trial for recurrent glioblastoma, with launch of a Phase 3 in platinum-resistant ovarian cancer expected by the end of the year.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
