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Notification report


Full notification file


General information

Notification Number
B/HU/17/05

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
28/07/2017

Title of the Project
A phase II study evaluating the efficacy and the safety of first-line chemotherapy combined with TG4010 and nivolumab in patients with advanced non-squamous Non-Small-Cell Lung Cancer (NSCLC)

Proposed period of release:
01/01/2018 to 31/03/2020

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:
Belgium; Denmark; France; Hungary;

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

If yes, notification number(s):
B/BE/11/BVW1; B/DE/11/PEI1419; B/ES/11/28; B/HU/15/01;

GMO characterization

GMO is a:
DNA Virus

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

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
MVAOrthopoxvirusvaccinia-Modified vaccinia virus Ankara-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known