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Notification report


Full notification file


General information

Notification Number
B/DE/20/PEI3941

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
09/07/2020

Title of the Project
A Phase I open-label, dose- escalation, safety, clinical activity, pharmacokinetic and pharmacodynamic study of intra- tumoral application of TMV-018 in combination with 5-Fluorocytosine or anti-PD-1 therapy in patients with tumors of the gastrointestinal tract.

Proposed period of release:
01/04/2020 to 31/12/2021

Name of the Institute(s) or Company(ies)
Themis Bioscience GmbH, Muthgasse 11/2
1190 Vienna
Austria;


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:
RNA Virus

Identity of the GMO:
TMV-018 is a recombinant, attenuated oncolytic MV, derived from the Schwarz strain of MV, which encodes a super cytosine deaminase (SCD) transgene.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
attenuated measles virusMorbillivirus--Schwarz strain-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
03/07/2020 00:00:00
Remarks: