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Notification report


Full notification file


General information

Notification Number
B/BE/20/BVW5-2

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
05/11/2020

Title of the Project
An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC (PDL1≥ 50%)

Proposed period of release:
28/02/2021 to 31/03/2023

Name of the Institute(s) or Company(ies)
Nouscom Srl, Rome, Italy;


3. Is the same GMO release planned elsewhere in the Community?
No

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Orthopoxvirus, Vaccinia Virus (strain MVA genetically modified to encode human tumor neoantigens and to impair replication)

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known