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.

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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. Both investigational drugs encode the same antigens, derived from four proteins of the HTLV-1 virus. The therapeutic vaccine is aiming at inducing an immune response against HTLV antigens born by ATL/L with the aim of enabling the patients’ immune system to fight leukemic cells.

In Europe, the Orphan designation is granted to drugs in development intended for the treatment, the prevention or the diagnosis of life-threatening or chronically-debilitating diseases of a prevalence lesser than 5 in 10,000 people. The designation allows sponsors to benefit from an accelerated development process as well as incentives and a 7 years market exclusivity once the drug is placed on the market.

“We expect to recruit our first patients towards the end of Q3 2015 in Europe and advance further developments in the U.S. and in Japan in 2016.” says Emmanuelle Sabbah-Petrover, Head of Regulatory Affairs.

Should the vaccine candidate demonstrate a convincing safety and efficacy profile during its development against ATL/L, the company is already considering the perspective of further developing the same vaccine candidate for HTLV-related infections as a therapy and possibly as a prophylactic approach.

The company Theravectys is originating from the Pasteur Institute. The company capitalizes over 15 years of fundamental research in the field of lentiviral vectors and has secured worldwide exclusive rights to Pasteur Institute intellectual property.

Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies to fight cancers and infectious diseases, including a proprietary and differentiated CAR T-cell technology platform. It’s also one of the first Biotech to test a vaccine against HIV in a clinical study. Another French company, Biosantech is also aiming to cure HIV infection with a therapeutic vaccine and is currently curing 80 patients in a Phase II study, the most advance trial for a HIV vaccine.

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