Clinical Trials

* On July 18, 2015, Theravectys, a Paris-based, fully-integrated discovery & clinical development company specialized in lentiviral vector-based therapeutic vaccines and T-cell therapies announced that detailed results from its phase I/II study will be presented at the 2015 Towards an HIV Cure Symposium in Vancouver, Canada, on 18 & 19 July 2015, immediately preceding the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention (IAS 2015).
The randomized, placebo-controlled trial currently enrolled 38 HIV-positive patients under HAART and aimed at comparing the safety, tolerability and immunogenicity of the therapeutic vaccine candidate at 3 different doses (5.10⁶, 5.10⁷ or 5.10⁸ TU) versus placebo. The treatment regimen consisted of two intramuscular injections 8 weeks apart with non-replicative and self-inactivating lentiviral vectors encoding for immunogenic regions of the HIV GAG, POL and NEF proteins. Vaccine-induced HIV-1-antigen-specific T-cell in peripheral blood were characterized by intracellular cytokine staining in all patients, placebo included, before and after HAART interruption 24 weeks after the first injection
With the absence of any serious adverse events on all 38 patients and no safety concerns related to the treatment, the clinical data confirmed both safety and tolerance of the lentiviral-based therapeutic vaccine. In addition, the analysis of the immunological data demonstrated the ability of the vaccine candidate to elicit multi-specific and poly-functional CD8 and CD4 T-cell responses in most of the vaccinated patients.
In this trial, a high frequency, from 0.097 to 0.874%, of functional T-cells able to produce at least 2 or 3 cytokines among IFN-γ, TNF-α and IL-2 was evidenced across patients. A dose effect was also observed when comparing the 3 groups, with greater magnitude with the highest dose.
* On November 18, 2014, Theravectys, a French biotechnology company specializing in the development of vaccines based on lentiviral vector technology, has reported 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 the remarkable safety profile of Theravectys lentiviral vector technology platform. In addition, the interim analysis of the immunological data from the first two cohorts of patients 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.

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. 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.

* On February 5, 2014, Theravectys has announced  the finalization of recruitment of patients for the first anti-HIV therapeutic vaccination trial, currently in progress in France and Belgium. This study of the first administration to humans aims to study the safety, tolerance and immunogenicity of its vaccine candidate in patients infected with HIV, undergoing highly active antiretroviral therapy (HAART). 36 patients were included in the study. Preliminary results will be available from June 2014 onwards and definitive results over the next 12 months.

* On November 30, 2012, Theravectys has announced it was granted authorization by the National Security Agency for Medicines and Health Products in France (Agence Nationale de Sécurité du Médicament et des produits de santé) and the Federal Agency for Medicines and Health Products in Belgium (Agence Fédérale des Médicaments et des Produits de Santé) to launch a phase I/II clinical trial for its anti-HIV therapeutic vaccine candidate based on lentiviral vector technology. With this first human trial, Theravectys not only intends to evaluate the safety and tolerance of its therapeutic vaccine candidate but also to measure the quality and intensity of the induced immune response.  This anti-HIV therapeutic vaccine should allow patients treated with antiretroviral drugs to stop taking them on a sustainable and perhaps permanent basis once vaccinated. The company expects to enroll the first patient before the end of the year.