Pexa-Vec Vaccine | BCH-LMO-SCBD-111973 | Living Modified Organism | Biosafety Clearing-House

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Living Modified Organism (LMO)
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Decisions on the LMO Risk Assessments  
last updated: 31 May 2017
Living Modified Organism identity
The image below identifies the LMO through its unique identifier, trade name and a link to this page of the BCH. Click on it to download a larger image on your computer. For help on how to use it go to the LMO quick-links page.
Pexa-Vec Vaccine
EN
JX-594
No
Pexa-Vec (Pexastimogene Devacirepvec) is a live-attenuated vaccinia virus that is is designed to target and destroy cancer cells. Multiple mechanisms of action for Pexa-Vec have been demonstrated in preclinical models and patients: 1) tumor cell infection and lysis, 2) antitumor immune response induction, and 3) tumor vascular disruption.

The recipient organism was modified to disrupt the endogenous thymidine kinase gene with the insertion of the coding sequence for each of human granulocyte macrophage-colony stimulating factor, and β-galactosidase enzyme.
EN
The term “Recipient organism” refers to an organism (either already modified or non-modified) that was subjected to genetic modification, whereas “Parental organisms” refers to those that were involved in cross breeding or cell fusion.
EN
Characteristics of the modification process
pSC65
EN
  • Other (Homologous Recombination)
Some of these genetic elements may be present as fragments or truncated forms. Please see notes below, where applicable.
  • BCH-GENE-SCBD-111969-1 Granulocyte macrophage-colony stimulating factor gene | Homo sapiens (HUMAN)
    Protein coding sequence | Production of medical or pharmaceutical compounds (human or animal) (Vaccines)
  • BCH-GENE-SCBD-45875-7 Beta-galactosidase gene | Escherichia coli (ECOLX)
    Protein coding sequence | Selectable marker genes and reporter genes
  • BCH-GENE-SCBD-111970-1 Early/Late promoter
    Promoter
  • BCH-GENE-SCBD-111971-1 P7.5 early/late promoter | Vaccinia virus (Poxvirus, Smallpox vaccine, VACV, VV, Vaccinia)
    Promoter
The pSC65 plasmid contining the GM-CSF gene was transfected by calcium phosphate precipitation into CV-1 monkey kidney cells that had been infected 2 hours previously with a low multiplicity of non-recombinant virus. The plasmid is designed to facilitate homologous recombination into the vaccinia thymidine kinase gene. This recombination event renders the endogenous thymidine kinase gene inactive which leads to viral replication being dependent on the high cellular thymidine kinase activity that is a hallmark of cancer cells.
EN
LMO characteristics
EN
  • Pharmaceutical
Detection method(s)
EN
Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Living modified organism(s) 2
Risk Assessment generated by a regulatory process Living modified organism(s) 2