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Notification report


Full notification file


General information

Notification Number
B/IT/17/02

Member State to which the notification was sent
Italy

Date of acknowledgement from the Member State Competent Authority
15/09/2017

Title of the Project
TG6006.01: A phase I/Па trial to evaluate the safety and efficacy of the combination of the oncolytic immunotherapy Pexa-Vec with the PD-1 receptor blocking antibody nivolumab in the first-line treatment of advanced hepatocellular carcinoma (HCC)

Proposed period of release:
01/07/2017 to 01/09/2019

Name of the Institute(s) or Company(ies)
Transgene SA, 400 Boulevard Gonthier d’Andernach
Parc d’Innovation
CS80166
67405 Illkirch Graffenstaden cedex - France;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
France;

Has the same GMO been notified elsewhere by the same notifier?
No

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 W 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