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Notification report


Full notification file


General information

Notification Number
B/ES/20/07

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
17/06/2020

Title of the Project
An Open-label Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI5395 in Combination with Durvalumab in Subjects with Select Advanced Solid Tumors

Proposed period of release:
01/03/2021 to 31/12/2025

Name of the Institute(s) or Company(ies)
MedImmune, LLC, ;


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):


GMO characterization

GMO is a:
RNA Virus

Identity of the GMO:
Genus Orthoavulavirus, Species Avian Orthoavulavirus 1 (AOAV-1)

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Newcastle Disease VirusOrthoavulavirusavianorthoavulavirus 1N/Aattenuated 73T strainN/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known