Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

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?

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

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