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Notification report

Full notification file


General information

Notification Number
B/BE/11/BVW1

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
05/07/2011

Title of the Project
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:


Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/BE/01/B7;

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 Name	Genus	Species	Subspecies	Strain	Pathovar
MVA	orthopoxvirus	vaccinia virus		Modified Virus Ankara

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known