Vaxin先入人的I期临床试验启动在慢性感染乙型肝炎患者

StephenW

Monday, July 27, 2015                  Vaxin First-in-Man Phase I Clinical Trial Initiated in Chronically Infected Hepatitis B Patients
GAITHERSBURG, MD, USA I July 27, 2015 I Vaxin Inc., a clinical stage vaccine and immunotherapeutics company, today announced that it has enrolled the first patient into a phase I clinical trial of HepTcell™ (FP-02.2), the company's immunotherapeutic compound to treat people chronically infected with the hepatitis B virus (HBV). The multi-center trial will be conducted at seven sites within the United Kingdom, and aims to recruit 72 patients with chronic HBV infection.

The trial is a randomized, double-blind, placebo-controlled dose-escalation study. The primary endpoints are safety and tolerability. Secondary endpoints include immunogenicity and antiviral factors. HepTcell will be tested as an add-on treatment to the patient's standard of care. Current therapy standards include treatment with antiviral drugs which act to control virus replication but are unable to eliminate the virus and therefore require long-term treatment. The combined treatment strategy aims to stimulate immune responses to a level that would increase the low clinical cure rates observed in patients treated with antiviral therapy alone. Initial results are expected in Q4 2016.

HepTcell is a peptide-based immunotherapeutic incorporating Vaxin's proprietary Densigen™ technology. This product candidate comprises nine long peptides covering conserved regions of core, polymerase and surface proteins from HBV, each linked to a fluorocarbon tail which acts to enhance immune responses. Using a bioinformatics platform, HepTcell has been designed to elicit T cell responses to each of the major infecting HBV genotypes, as well as in an ethnically diverse population, thereby allowing applicability across a world-wide market. Treatment with HepTcell aims to restore functional T cell immune responses to the hepatitis virus in HBV-infected subjects where the natural immune responses are lacking or poor.

Professor Mark Thursz, MD PhD, a world expert in the treatment of hepatitis from Imperial College London, and chief investigator, said, "We are very excited to start this multi-center clinical study. Treatments like HepTcell that are designed to restore the immune response, offer a long-term treatment solution to chronically-infected hepatitis B patients, potentially allowing them to stop their antiviral medication."

"This is a continuation of the exciting work we obtained through the acquisition of Immune Targeting Systems earlier this year," said Bill Enright, CEO of Vaxin. Enright continued, "Pre-clinical development and manufacturing was co-funded through the UK's innovation agency, Innovate UK (formerly Technology Strategy Board) for £2.0 million ($3.1 million), and a parallel funding commitment of $16 million from Vaxin investors."
About Chronic HepatitisHepatitis B virus (HBV) has infected >2 billion people worldwide, of whom more than 360 million people (5 percent of the world's population) remain chronically infected. HBV is the tenth leading cause of death worldwide, with over 600,000 HBV-related deaths per year and >36,000 in Europe. Life-threatening liver disease (cirrhosis, liver failure and hepatocellular carcinoma) occurs in as many as 40 percent of patients with chronic hepatitis B (CHB). Even though prophylactic vaccination programs have led to declines in new HBV infections in many countries, CHB infection is a rapidly growing problem in Europe due to immigration of HBV carriers from endemic areas, and transmission from mother to child. The treatment of CHB has improved dramatically in the last 10 years, owing to the development of new antiviral compounds, including polymerase inhibitors or pegylated alpha-interferon. Despite significant retardation in HBV-related disease progression and reduction in mortality, those treatments rarely achieve clinical cure.

About VaxinVaxin Inc. is a clinical stage biotechnology company developing next-generation vaccines and immunotherapeutics to address significant public health and biodefense needs. By leveraging specific attributes of its two independent and complementary platform technologies, Vaxin can rapidly design product candidates against a wide range of disease targets, including respiratory diseases, chronic infections, and cancer. Our Densigen™ T-cell platform technology is uniquely suited to direct the immune response against traditionally difficult disease targets, including chronic infections and cancer, by directing an individual's immune system against multiple target antigens instead of just one. Vaxin's RespirVec™ platform utilizes convenient needle-free intranasal delivery to achieve broad immunity against disease pathogens more rapidly than conventional vaccines. Vaxin's product candidates are easily manufactured, highly stable, and provide a safe, effective alternative to current products. www.vaxin.com.
SOURCE: Vaxin

Posted byHCV Advocateat6:14 PM

StephenW

周一，2015年7月27日
Vaxin先入人的I期临床试验启动在慢性感染乙型肝炎患者
马里兰州盖瑟斯堡，美国我2015年7月27日我公司Vaxin，临床阶段的疫苗和免疫疗法公司，今天宣布，该公司已经招收了第一个病人进入一个阶段我HepTcell™（FP-02.2）的临床试验中，该公司的免疫治疗化合物待人慢性感染乙型肝炎病毒（HBV）。多中心试验将在英国范围内七个地点进行，并计划招募72例慢性HBV感染。

该试验是一项随机，双盲，安慰剂对照的剂量递增的研究。主要终点是安全性和耐受性。次要终点包括免疫原性和抗病毒因子。 HepTcell将被测试作为一个附加的治疗护理的病人的标准。目前的治疗标准包括与抗病毒药物，其作用是控制病毒的复制，但无法消除病毒，因此需要长期治疗的治疗。联合治疗策略的目的是刺激免疫反应的水平，将增加与单纯抗病毒治疗的患者中观察到的较低临床治愈率。初步结果预计将在2016年第四季度。

HepTcell是一种肽基免疫治疗结合Vaxin专有Densigen™技术。此产品候选人包括九久肽覆盖从HBV核心，聚合酶和表面蛋白，每个链接到氟碳尾巴起到增强免疫反应的保守区域。使用生物信息学平台，HepTcell已被设计为引起T细胞对每个主要感染HBV基因型的，以及在一个不同种族的人群中，从而允许横过一个世界范围的市场应用性。治疗HepTcell目的是恢复功能的T细胞免疫反应肝炎病毒乙肝病毒感染者，其中的天然免疫反应缺乏或贫穷。

教授马克Thursz，医学博士，一个世界级专家来自伦敦帝国学院肝炎的治疗和首席调查员说，“我们非常高兴能够启动这个多中心临床研究。像HepTcell治疗，旨在恢复免疫响应，提供一个长期处理溶液慢性感染乙型肝炎的患者，可能允许他们停止抗病毒药物“。

“这是一个延续我们通过收购的免疫系统靶向今年早些时候获得的令人兴奋的工作，”比尔·恩莱特，Vaxin的首席执行官说。恩莱特继续说，“通过英国的创新机构临床前开发和制造是共同出资，创新UK（前身为技术战略委员会）2.0万英镑（3100000美元），以及1600万美元来自Vaxin投资者并行的资金承诺。”

关于慢性HepatitisHepatitis乙肝病毒（HBV）感染了>世界范围2十亿人，其中360多万人（5％的世界人口）保持慢性感染。乙肝病毒是致死的第十大原因世界范围内，每年有超过60万乙肝病毒相关的死亡和> 36 000欧。威胁生命的肝脏疾病（肝硬化，肝功能衰竭和肝细胞癌）发生在慢性乙型肝炎（CHB）多达40％。尽管预防接种方案已导致新的感染乙肝病毒在许多国家的下降，CHB感染是在欧洲迅速发展的问题，是由于移民来自流行区，乙肝病毒携带者，和传输由母亲传染给孩子。 CHB的治疗已显着提高，在过去10年中，由于新的抗病毒化合物，包括聚合酶抑制剂或聚乙二醇化的α-干扰素的发展。尽管HBV相关疾病进展，降低显著迟缓，死亡率，治疗的那些很少达到临床治愈。

关于VaxinVaxin Inc.是一家临床阶段的生物技术公司，开发下一代疫苗和免疫治疗，以解决显著公共卫生和生物防御的需要。通过利用其两个独立和互补的平台技术特定的属性，Vaxin可以快速设计候选产品针对广泛的疾病靶，包括呼吸系统疾病，慢性感染和癌症。我们Densigen™T细胞的平台技术是唯一适合于直接针对传统上疑难病的目标，包括慢性感染和癌症的免疫应答，通过引导一个个体的免疫系统针对多个靶抗原而不仅是一个。 Vaxin的RespirVec™平台采用方便的无针鼻内传递，实现对疾病的病原体的免疫广阔比更迅速地常规疫苗。 Vaxin的候选产品容易制造的，高度稳定的，并且提供一个安全，有效的替代现有产品。 www.vaxin.com。

来源：Vaxin
发贴者HCV提倡在下午6点14

StephenW

Our Densigen platform provides a versatile approach for the creation of immunomodulatory products promoting broad and robust T cell immunity against multiple indications including chronic infections and cancer. Densigens are rationally-designed long, fully-synthetic peptides containing natural clusters of CD4+ and CD8+ T-cell epitopes. We use a proprietary bioinformatic approach to select the most immunogenic and conserved domains of viral and tumor antigens. Densigens are conjugated to a fluorocarbon moiety to increase the immunogenicity of the product. Through careful selection and by combining several Densigens into a single formulation, products can be developed that engage nearly everyone’s immune system, by-passing the HLA-restriction that limits the usefulness of most other T-cell immunotherapies. The Densigen technology can be widely applied to the development for the therapeutic vaccines against both cancer and chronic viral infections where T-cell immunity is required for prevention or treatment of disease. The safety and immunogenicity of this vaccine platform has been demonstrated across four clinical studies in more than 200 young and older adults.
我们Densigen平台为创造产品的免疫促进对多种适应症包括慢性感染和癌症广泛而强大的T细胞免疫的通用方法。 Densigens被合理设计的含有CD4 +和CD8 + T细胞表位的天然簇长，全合成肽。我们使用专有的生物信息学的方法来选择病毒和肿瘤抗原的免疫原性最强和保守结构域。 Densigens缀合到氟烃部分，以增加产品的免疫原性。通过仔细选择和通过组合几个Densigens成一个单一的制剂，可将产品开发接合几乎每个人的免疫系统，通过传递与HLA-限制，其限制大多数其它的T细胞的免疫疗法的有效性。该Densigen技术可广泛应用于开发用于对抗癌症和其中需要预防或治疗疾病的T细胞免疫慢性病毒感染的治疗性疫苗。这种疫苗平台的安全性和免疫原性已被证明在四个临床研究在200多个年轻人和老年人。

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