November 18, 2014
THERAVECTYS, a fully-integrated discovery and clinical development biotechnology company focusing on the development of therapeutic vaccines and immunotherapies, reports promising preliminary results in the first-ever vaccination trial conducted with lentiviral vectors.
The randomized, placebo-controlled trial currently enrolls 38 HIV-positive patients under highly active antiretroviral therapy (HAART) in 12 clinical sites in France and Belgium and aims at comparing the safety, tolerability and immunogenicity of its therapeutic vaccine candidate at 3 different doses (5.106, 5.107 or 5.108 TU) versus placebo.
The treatment regimen consists of two intramuscular injections with non-replicative and self-inactivating lentiviral vectors encoding for disease-specific antigens under the regulation of THERAVECTYS patent-protected human promoter (ß2-microglobulin).
With the absence of any serious adverse events on all 38 patients and no safety concerns related to the product, the interim results confirm theremarkable safety profile of THERAVECTYS lentiviral vector technology platform.
In addition, the interim analysis of the immunological data from the first two cohorts of patients performed by THERAVECTYS demonstrates the ability of the vaccine candidate to elicit multi-specific and poly-functional CD4+ and CD8+ cellular immune responses in vaccinated patients. The immune response elicited by the vaccine was observed even at the lowest dose.
Upon completion of the study in December 2014, detailed results will be presented in peer-reviewed communications at international congresses and in scientific publications.
The interim analysis of this trial supports the potential of the lentiviral vector platform developed by THERAVECTYS for the future development of therapeutic vaccines and immunotherapies in oncology and infectious diseases.
Within the next few months, THERAVECTYS expects to initiate a phase I/II clinical trial with its immunotherapy candidate against HTLV-1-induced adult T-cell leukemia/lymphoma and to initiate a dialogue with regulatory agencies on the clinical development of its proprietary CAR T-cells.
THERAVECTYS is privately-owned, fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute.
THERAVECTYS 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.
The company is strongly supported by renowned investors and former global biopharmaceutical executives and is rapidly progressing in its R&D activities and in-house GMP production capabilities.
Alone and in collaboration with partners, THERAVECTYS is accelerating its clinical development programs and is planning to initiate two additional phase I/II clinical trials in oncology in 2015.