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Notification report


Full notification file


General information

Notification Number
B/DE/11/PEI1419

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
01/08/2011

Title of the Project
The project, TG4010.14 clinical trial, is entitled “A Phase IIb/III randomized, double-blind, placebo-controlled study comparing first-line therapy with or without TG4010 immunotherapy product in patients with stage IV non-small cell lung cancer (NSCLC)”

Proposed period of release:
01/12/2011 to 31/12/2015

Name of the Institute(s) or Company(ies)
Transgene S.A., ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; Spain; France; United Kingdom; Italy; Hungary; Poland; Bulgaria;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
The final genetically modified organism (GMO) is TG4010 and consists of a poorly replicative, recombinant vaccinia vector consisting of the modified vaccinia virus Ankara (MVA) genome containing inserted transgenes that encode two proteins: the human mucine 1 (MUC1) and the human interleukin-2 (IL2).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
MVAOrthopox virusvaccinia virus-Modified Virus Ankara-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
21/12/2011 00:00:00
Remarks: