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Notification report


Full notification file


General information

Notification Number
B/NL/19/003

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
19/02/2019

Title of the Project
An open-label, Phase I/II multicenter clinical trial of VXM01 in combination with avelumab in patients with progressive glioblastoma following standard treatment, with or without second surgery. Study Code VXM01-AVE-04-INT

Proposed period of release:
01/08/2018 to 01/08/2021

Name of the Institute(s) or Company(ies)
VAXIMM GmbH, MAFINEX-Technologiezentrum
Julius-Hatry-Stra├če 1
68163 Mannheim;


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

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

If yes, notification number(s):
B/DE/11/PEI1393; B/DE/15/PEI2509; B/DE/16/PEI2516;

GMO characterization

GMO is a:
Bacterium

Identity of the GMO:
Order of the parental organism: Enterobacteriales
Genus of the parental organism: Salmonella
Species and Subspecies of the parental organism: Salmonella enterica subsp. enterica Serovar Typhi Strain Ty21a


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
S. TyphiSalmonellaentericaentericaTy21aSerovar Typhi

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
05/06/2019 00:00:00
Remarks: