Advanced Therapy Medicinal Product classification for Ixaka Ltd’s chemically encapsulated lentiviral vector
The EMA has granted an Advanced Therapy Medicinal Product (ATMP) classification for Ixaka Ltd’s chemically encapsulated lentiviral vector for targeted in vivo CAR T-cell therapy, CELTIC-19.
ATMP status was confirmed due to its potential as a gene therapy medicinal product that targets specific cells and expression of the gene directly within the patient’s body. This approach can eliminate all the ex vivo stages of genetic modification, which are required for the production of cell therapy products currently on the market.
CELTIC-19 consists of a polymer nanoparticle encapsulating a bald lentiviral vector encoding for a T-cell specific promoter and the chimeric antigen receptor. The nanoparticle is coated with a CD3 binding molecule, which allows for in vivo targeting and transduction of the T-cells. This can then be infused systemically into the bloodstream to target and genetically modify T-cells within the body.
Gilbert Wagener, Senior Vice President, CMO at Ixaka, commented: “TNP-based in vivo CAR T-cell therapies such as Ixaka’s represent a significant advance over recently approved ex vivo CAR T-cell therapies, and hold the promise of delivering more effective, universal, and safer treatment option for patients. It is great to see this potential recognized by the European Medicine Agency.”
Meanwhile, Joe Dupere, CEO at Ixaka, explained: “Our nanoparticle-based in vivo gene delivery technology is ideally positioned to deliver on the promise of in vivo CAR-T therapies to transform cancer treatment without the need for costly dedicated manufacturing sites for T-cell modification.
The designation of CELTIC-19 as an Advanced Therapy Medicinal Product further signifies its potential as a ground-breaking new treatment option and is an important step on our continued journey,” he added.