THERAVECTYS, a fully-integrated discovery and clinical development biotechnology company focusing on the development of therapeutic vaccines and immunotherapy, announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to its therapeutic vaccine candidate for the treatment of Adult T-cell Leukemia/Lymphoma (ATL/L).
ATL/L is a rare malignancy of a certain type of white cells, T-Lymphocytes, caused by the Human T-Cell Lymphotropic Virus type 1 (HTLV-1) with a prevalence up to 1% of the overall population in Japan. Approximately 5% of all patients infected with HTLV-1 will develop ATL/L, in their lifetime.
Four ATL/L subtypes have been described, with a poor prognosis (less than a year for the two most aggressive forms). Patients are confronted with a lack of well-tolerated and/or performant treatment options which, to-date, include biological treatments with serious adverse reactions as well as aggressive chemo and antiviral therapies or, when eligible, long and uncertain hematopoietic stem cell transplantation.
THV02 is an experimental treatment composed of two lentiviral vectors to be used in a prime/boost regimen in ATL/L patients infected by the HTLV-1 virus.