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Notification report


Full notification file


General information

Notification Number
B/ES/18/29

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
10/10/2018

Title of the Project
A phase Ib/II trial evaluating the combination of TG4001 and avelumab in patients with HPV-16 positive recurrent or metastatic malignancies and expansion cohort to oropharyngeal squamous cell carcinoma of the head and neck (SCCHN).
Study code: TG4001.12


Proposed period of release:
01/03/2019 to 31/12/2020

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?
No

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

If yes, notification number(s):
B/BE/09/BVW1;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
The final genetically modified organism (GMO) is TG4001 and consists of a poorly replicative, recombinant vaccinia vector consisting of the modified vaccinia virus Ankara (MVA) genome containing inserted transgenes that encode for the modified forms of the human papillomavirus type 16 (HPV16) E6 and E7 proteins (delE6 and delE7) and the human cytokine IL2 (hIL2).

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known