Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
The OVAL Study: A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer

Proposed period of release:
01/05/2020 to 31/12/2022

Name of the Institute(s) or Company(ies)
Vascular Biogenics Ltd. (VBL Therapeutics), ;

3. Is the same GMO release planned elsewhere in the Community?
Spain; United Kingdom; Poland; Bulgaria;

Has the same GMO been notified elsewhere by the same notifier?

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Order: Adenovirus
Genus: Mastadenovirus
Species: human adenovirus
Strain: serotype 5
Common name: Ad5
The GMO/IMP VB-111 is an anti-angiogenic agent based on an adenovirus vector. It is a
non-replicating E1 deleted, Adenovirus 5, carrying a transgene expressing a pro-apoptotic
human Fas chimera under the control of a modified murine promoter (PPE-1-3x). The
transgene is specifically expressed in angiogenic endothelial cells. The GMO is intended for
therapeutic purposes to target solid tumors using a dual mechanism of action: antiangiogenesis
and stimulation of immune system.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
human adenovirus serotype 5Mastadenovirushuman adenovirussubgroup Chuman serotype 5 (Ad5)N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known