PARIS, France I July 18, 2015 I THE

PARIS, France I July 18, 2015 I 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 (ClinicalTrials.gov Identifier:NCT02054286) 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
“We are very pleased to present the clinical data of this first-ever lentivector based therapeutic vaccine trial” says Dr. Hélène TOUSSAINT, senior scientist in charge of the HIV vaccine program.
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.
"These data provide further evidence that THERAVECTYS' regimen vaccine is safe and well tolerated, and can induce intense, broad and long-lasting cellular immune responses in vaccinated patients regardless their preexisting immune profile" says Dr. Cécile BAUCHE, Chief Scientific Officer of the Company.
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.
"The clinical data 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.” says Renaud VAILLANT, Chief Executive Officer, THERAVECTYS.
For a complete review of THERAVECTYS’ technologies & programs, please visit the company’s website.
About THERAVECTYS
THERAVECTYS is a fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute. 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.
Capitalizing over 15 years of fundamental research in the field of lentiviral vectors, the company has built a broad and robust intellectual property position in addition to worldwide and exclusive licenses secured from institutions including Institut Pasteur and Institut Curie.
The company’s lead infectious disease lentivector vaccine has successfully completed a Phase I/II safety & immunogenicity human proof-of-concept study in HIV. THERAVECTYS lead oncology lentivector vaccine will enter clinical trials in 2015 while the company’s CAR T-cell therapies are in the preclinical stage.
Alone or with partners, THERAVECTYS plans to advance its pipeline of oncology and infectious disease therapies using the company’s integrated set of discovery, clinical development, and GMP manufacturing capabilities specialized in lentiviral vector technologies.
SOURCE: Theravectys

結果 (中文) 1:

法国巴黎我 2015 年 7 月 18 日我 THERAVECTYS，总部设在巴黎的、 完全集成的发现与临床开发公司专业从事基于矢量的慢病毒治疗性疫苗和 T 细胞疗法宣布详细源自其相位 / II 研究将在加拿大温哥华，艾滋病毒治疗研讨会走向 2015年就提出 18 & 2015 年 7 月 19 日，紧接第八届国际会计准则会议上艾滋病毒发病机制处理及预防 (IAS 2015 年)。随机、 安慰剂对照试验 (ClinicalTrials.gov 标识符: NCT02054286) 目前招收下 HAART 38 艾滋病毒阳性患者，旨在比较安全，耐受性和免疫原性的在三种不同剂量 (5106、 5.107 或 5.108 TU) 与安慰剂治疗性疫苗候选。治疗方案包括的肌内注射两次相隔 8 周与非复制和自我灭活慢病毒载体的免疫原性区域艾滋病毒 GAG、 POL 和 NEF 编码的蛋白质。疫苗诱导 HIV-1-抗原特异性 T 细胞在外周血的特点是细胞内细胞因子染色在所有的病人，包括 HAART 中断前后第一次注射后 24 周的安慰剂"我们感到非常高兴，首次提出的临床资料，这 lentivector 基于治疗性疫苗审判"说博士海伦杜桑，资深科学家负责艾滋病疫苗项目。由于缺乏任何严重的不良事件，所有的 38 例及有关治疗没有安全问题，临床数据证实安全性和耐受性的慢病毒为基础的治疗性疫苗。此外，免疫数据的分析表明候选疫苗诱发多具体和聚功能 CD8 及 CD4 T 细胞反应，在接种疫苗的病人，大部分的能力。"这些数据提供进一步的证据表明，THERAVECTYS 的养生疫苗是安全和耐受性良好，可以诱发强烈、 广泛和持久的细胞免疫反应中接种疫苗的患者无论他们先前存在的免疫配置文件"博士塞西尔歇，公司首席科学官说。在这个试验中，高频率，从为 0.097 0.874%，功能性 T 细胞能够产生至少 2 或 3 细胞因子之间 IFN-γ，肿瘤坏死因子 α、 白细胞介素-2，这体现在患者。剂量效应也观察到，比较 3 组，用更大的值，最高剂量时。"这次审判的临床数据支持的慢病毒载体平台开发的 THERAVECTYS 的治疗性疫苗和肿瘤学和传染病流行的免疫治疗未来的发展潜力"说雷诺威能，首席执行官，THERAVECTYS。进行全面的检讨，THERAVECTYS 的技术与程序，请访问本公司网站。关于 THERAVECTYSTHERAVECTYS 是一个完全集成的发现和源自巴斯德研究所的临床开发生物技术公司。其慢病毒载体技术平台基础，THERAVECTYS 开发治疗性疫苗和防治癌症和传染病，对肿瘤的免疫，包括专有和区分汽车 T-细胞技术平台。利用超过 15 年的慢病毒载体领域的基本研究，公司建有世界各地和独占许可证担保机构包括巴斯德研究所和研究所居里从广泛和鲁棒性知识产权职务。二、 安全性及免疫原性人类--概念证明在艾滋病毒研究/公司的铅传染病 lentivector 疫苗已成功地完成一个阶段我。THERAVECTYS 铅肿瘤学 lentivector 疫苗将在 2015 年进入临床试验，而该公司的汽车 T-细胞疗法是在临床前阶段。独自或与伴侣，THERAVECTYS 计划推进肿瘤及其管道和传染性疾病治疗方法使用本公司的综合设置，发现，临床发展，和 GMP 制造能力专门在慢病毒载体技术。来源: Theravectys