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
ISI-JX - A Phase I trial evaluating the impact of an in situ Immunization strategy with Intra-Tumoral Injections of Pexa-Vec in combination with ipilimumab in advanced solid tumors with injectable lesions

Proposed period of release:
01/07/2016 to 30/09/2019

Name of the Institute(s) or Company(ies)
Centre Léon Bérard, Centre Régional de Lutte contre le Cancer
28 rue Laënnec
69008 Lyon

3. Is the same GMO release planned elsewhere in the Community?

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Orthopoxvirus
Species: Vaccinia virus (VV)

The GMO is a viral suspension of the recombinant virus JX-594. JX-594 is a non-integrative, replicative, propagative, recombinant VV derived from the commonly used commercial vaccine Wyeth strain. JX-594 differs by three genetic modifications from the wild type Wyeth strain: 1) disruption of the viral thymidine kinase (TK) gene by, 2) insertion of the human granulocyte macrophage-colony stimulating factor (hGM-CSF) gene and 3) insertion of the lacZ gene.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
vaccinia virusOrthopoxvirusvaccinia virus-Wyeth-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known