Back

Notification report


Full notification file


General information

Notification Number
B/ES/20/15

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
31/07/2020

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:
01/10/2020 to 31/10/2023

Name of the Institute(s) or Company(ies)
Nouscom Srl, Via di Castel Romano, 100, 00128 Roma RM, Italy;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Spain; United Kingdom;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus Adenovirus, Species GAd20 Gorilla adenovirus (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
GAd20AdenovirusGorilla adenovirus-GAd20-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known