CELTIC-19 (Chemically Encapsulated Lentiviral vector for Targeted In Vivo CAR T-cell therapy) granted ATMP status by EMA

Ixaka has announced that its Chemically Encapsulated Lentiviral vector for Targeted In Vivo CAR T-cell therapy (CELTIC-19) targeted nanoparticle (TNP) product has been granted ATMP classification by the EMA in the treatment of CD19 haematological malignancies.

CELTIC-19 consists of a polymer nanoparticle encapsulating a bald lentiviral vector encoding for a T-cell specific promoter and the chimeric antigen receptor (CAR). The nanoparticle is coated with a CD3 binding molecule allowing in vivo targeting and transduction of the T-cells. The construct can then be infused systemically into the bloodstream to target and genetically modify T-cells within the body. This approach allows the generation of CAR T-cells which are potentially more efficacious, safer, and considerably less expensive to produce than established CAR T-cell therapies, which have been shown to be effective and have been approved for use in CD19-malignancies.

Fonte: Press Release