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THV02 is a therapeutic vaccine candidate developed by Theravectys for the treatment of adult T-cell leukemia/lymphoma (ATL/ATLL) induced by human T-cell leukemia virus type 1 (HTLV-1). The vaccine is composed of two non-integrative lentiviral vectors designed to be administered in a prime/boost regimen. THV02 encodes a unique polypeptide derived from four HTLV-1 viral proteins: Tax, HBZ, p12I, and p30II, which are involved in HTLV-1 pathogenicity and are recognized by the host immune system. By targeting dendritic cells, THV02 aims to stimulate a robust and long-lasting cellular immune response (specifically CD4+ and CD8+ T-cell responses) against HTLV-1 antigens, enabling the patient's immune system to target and eliminate leukemic cells. THV02 was granted Orphan Drug Designation by the European Medicines Agency (EMA) in 2015 and is currently in preclinical development.
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