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Notification report


Full notification file


General information

Notification Number
B/BE/20/BVW3

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
13/08/2020

Title of the Project
A Phase I/IIa study of intra-tumoral BT-001 (TG6030) administered alone and in combination with pembrolizumab in patients with cutaneous or subcutaneous lesions or easily injectable lymph nodes of metastatic/advanced solid tumors.
Study code: BT-001.01


Proposed period of release:
30/10/2020 to 30/09/2024

Name of the Institute(s) or Company(ies)
Transgene S.A., ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
France;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Orthopoxvirus
Species: Vaccinia virus (VV)

The genetically modified organism (GMO) is a viral suspension of the recombinant virus BT-001 (TG6030), a non-integrative, conditionally replicative, recombinant thymidine kinase and ribonucleotide reductase-double deleted vaccinia virus of Copenhagen strain (VV-COP TK- RR-) carrying DNA sequences encoding the human Granulocyte-Macrophage Colony stimulating factor (hGM-CSF) and 4-E03, a human monoclonal antibody of the IgG1 isotype targeting the human Cytotoxic T-Lymphocyte-Antigen 4 (anti-hCTLA-4 mAb).

For the purposes of this document:
• The Parenteral virus is defined as the vaccinia virus of the Copenhagen strain (VV-COP)
• The Recipient is defined as COPTG19156, a thymidine kinase and ribonucleotide reductase-double deleted vaccinia virus of Copenhagen strain (VV-COP TK- RR-) carrying DNA sequences encoding the green fluorescent protein (GFP) and the mCherry genes at the TK and RR loci respectively.
• The Vectors are defined as the transfer plasmids pTG19367 and pTG19384.
• The name for the Genetically Modified Organism (GMO) is BT-001 [Drug Product], COPTG19384 [Drug Substance] or VV-COP TK- RR- / 4-E03 anti-hCTLA-4 mAb / hGM-CSF.


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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known