News:Transgene's therapeutic vaccine candidate (TG1050)

StephenW

TRANSGENE : Transgene's New Therapeutic Vaccine Candidate (TG1050) to Treat Chronic Hepatitis B ("CHB") Reaches Pre-Clinical Proof of Concept04/19/2012 | 02:05am            

•         Long-term control of hepatitis B remains a major unmet medical need
•         Positive pre-clinical data supports future clinical development
•         Poster presentation at EASL, Barcelona, April 19, 2012
  

   

Regulatory News:   

Transgene (Euronext Paris: TNG, FR0005175080) today announced that it has achieved pre-clinical proof of concept with a new therapeutic vaccine candidate, TG1050, aiming at treating chronic infection by the hepatitis B virus ("HBV").   
Positive pre-clinical data supports further development of the product. These data include:   

• Robust and broad immune (T cell) response in pre-clinical models after one or more injections;
• Potent in vivo cytolysis1 against several epitopes2; and
• Genetic stability of the vaccine.
  

Despite the introduction in the past decade of efficacious new drugs (Nucleoside analogs - "NUCs"- and PEG-IFN?) to treat CHB, these drugs result only rarely in the resolution of the infection, which is defined by the disappearance of circulating hepatitis B virus surface antigen  ("HBsAg") and a measurable antibody response against this same antigen, or HBsAg seroconversion3.   
In combination with standard of care, TG1050 has the potential to increase the level of seroconversion in comparison to current treatments, and thus could provide a new option for the cure of the infection.   
The product is expected to enter clinical development in 2014.   
"The promising preclinical proof of concept on this new vaccine candidate, together with the clinical efficacy data obtained with TG4040, our therapeutic vaccine against hepatitis C, proves again the excellence of Transgene's research in the field of infectious diseases" said  Philippe Archinard, Chairman and CEO of Transgene. He added: "Although the management of CHB has significantly improved over the past decade, the long-term control of the infection is very rarely achieved and  patients have to endure decades-long treatments. We believe that a combination of TG1050 with the standard of care could potentially help       to cure the infection, providing relief to millions of patients".   
Transgene's HBV research program will be presented today in a poster at the EASL congress (European Association for the Study of Liver),  in Barcelona, Spain. During the same EASL congress (on April 21, 2012), Pr. Heiner Wedemeyer, MD, of the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School (Germany), will give a "late breaker" oral presentation and present follow up data from  the randomized Phase 2b clinical trial with TG4040, a therapeutic vaccine against chronic hepatitis C infection for which initial proof of concept data were released at AASLD in November 2011.   
About HBV:   
According to the World Health Organization's ("WHO") estimates, 350 million people are chronic carriers (WHO, 2009) of HBV. Hepatitis B is more common in some parts of the world than others. In China and other parts of Asia, up to 10% of the population is believed to be chronically infected. In addition to the significant burden of disease, CHB is       responsible for 1 million deaths each year due to related complications  such as liver failure, cirrhosis or hepatocellular carcinoma (liver cancer).   
About Transgene's HBV vaccine:   
Transgene's therapeutic CHB vaccine is based on a recombinant  non-replicative human adenovirus serotype 5, expressing multiple specific HBV antigens (Core, Envelope and Polymerase) from genotype D. The vaccine has been designed to prime de novo and/or stimulate  functional T-cells expected to control the HBV replication and to elicit  viral clearance.   
About Transgene:   
Transgene, a member of the Institut Mérieux Group, is a publicly traded French biopharmaceutical company dedicated to the development of  therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases and has four compounds in Phase 2 clinical development: TG4010 and JX594/TG6006 having already completed initial Phase 2 trials, TG4001 and TG4040. Transgene has concluded strategic       agreements for the development of two of its immunotherapy products: an option agreement with Novartis for the development of TG4010 to treat various cancers and an in-licensing agreement with US-based Jennerex, Inc. to develop and market JX594/TG6006, an oncolytic virus. Transgene has bio-manufacturing capacities for viral-based products. Additional information about Transgene is available at www.transgene.fr.   

StephenW

转基因转基因的新的治疗性疫苗候选（TG1050）治疗慢性乙型肝炎（慢性乙肝“）达到临床前概念证明
2012年4月19日| 02:05

    长期控制乙肝仍然是一个重大的未满足的医疗需求
    积极的临床前数据支持未来的临床发展
    海报展示在欧洲肝病学会，巴塞罗那4月19日，2012年


监管新闻：

转基因（巴黎证交所：过渡政府，FR0005175080）今天宣布，它已达到一个新的治疗性疫苗的候选人，TG1050，以治疗慢性B型肝炎病毒感染，（“乙肝”）的临床前的概念证明。

积极的临床前数据支持该产品的进一步发展。这些数据包括：

    强大而广泛的免疫反应（T细胞）一个或多个次注射后的临床前模型;
    强有力的体内cytolysis1对几个epitopes2;和
    该疫苗的遗传稳定性。

尽管在过去十年引进的新的有效药物（核苷类似物 - “NUCs” - ？和PEG-干扰素）治疗慢性乙型肝炎的感染，这是循环型肝炎的失踪定义的决议，这些药物的结果，只有很少乙肝病毒表面抗原（“乙肝表面抗原”）和衡量反对此相同的抗原抗体反应，或HBsAg seroconversion3。

TG1050护理标准的结合，有可能增加血清转化水平比较，目前的治疗方法，从而可以治愈的感染提供新的选择。

该产品预计在2014年进入临床开发。

“的有前途的概念临床证明这种新的疫苗候选连同的临床疗效与TG4040获得的数据，上，我们对丙型肝炎的治疗疫苗，证明再次在传染病领域的卓越转基因的研究”说，菲利普Archinard，主席和首席执行官转基因。他补充说：“虽然在过去十年显着改善慢性乙型肝炎管理，长期控制感染是很少实现，病人不得不忍受长达数十年的治疗，我们相信，与标准相结合的TG1050护理可能有助于治疗感染，数以百万计的患者提供救济“。

转基因的HBV的研究计划将提交今天在欧洲肝病学会大会（欧洲肝病研究协会）的海报，在西班牙巴塞罗那。在同欧洲肝病学会大会（2012年04月21日），PR。 Heiner Wedemeyer博士医学院汉诺威（德国）胃肠病，肝病和内分泌部，将给予“后期断路器”的口头报告，并提出与TG4040随机2b期临床试验，治疗性疫苗对后续数据慢性丙型肝炎病毒感染的概念，数据的初步证明在肝病学会于2011年11月被释放。

关于乙肝病毒：

据世界卫生组织（“世卫”）的估计，有350万人是乙型肝炎病毒慢性携带者（WHO，2009）。 B型肝炎是较常见的比其他一些世界各地。在中国和亚洲其他地区，高达10％的人口被认为是慢性感染。除了显著的疾病负担，慢性乙型肝炎是1万人死亡，每年由于有关的并发症，如肝功能衰竭，肝硬化或肝癌（肝癌）负责。

关于转基因乙肝疫苗：

转基因的治疗慢性乙肝疫苗是基于重组非复制人类腺病毒5型，总理从头和/或刺激功能的T细胞疫苗已经设计表达多个特定的D基因型HBV抗原（核心，信封和聚合酶）预计控制乙肝病毒复制，并引发病毒清除。

关于转基因：

转基因研究所梅里埃集团的成员，是一家公开上市的法国生物制药公司，致力于开发治​​疗肿瘤和传染病的疫苗和免疫治疗产品，并有四个阶段的化合物临床开发：TG4010和JX594/TG6006已经完成2项试验的初始阶段，TG4001和TG4040。转基因已签订战略合作协议，其免疫产品开发两个：与诺华公司，为TG4010发展的以治疗各种癌症的期权协议，并与总部设在美国Jennerex，公司在许可协议，开发和市场JX594/TG6006溶瘤病毒。转基因的病毒为基础的产品有生物制造能力。有关转基因的额外资讯是在www.transgene.fr提供。

cwy121

好消息，总算一个希望。。。

迷惘彬彬

2014年才开始临床，临床几期得几年吧，然后本土上市，引进到天朝药监起码3-5年才让入大陆，这样一算我们要用得到起码是10年以后的事，我们的青春早没有了，而且身体已经老化，都不知道能不能用得上···残念

StephenW

回复 迷惘彬彬 的帖子

科学发展非常迅速，开发新的药物可以更快.

迷惘彬彬

StephenW 发表于 2012-4-20 21:38
回复 迷惘彬彬 的帖子

科学发展非常迅速，开发新的药物可以更快.

希望吧，像什么合成肽···闻大姐的乙克估计已经开发成杀虫水了，希望老外能帮助我们乙肝病人脱离苦海

咬牙硬挺

确实是好消息！又多了一个希望啊

newchinabok

乙肝免疫治疗新药TG1050可诱导多特异性、多功能、强力、持久的T细胞应答 ——  作者:    时间:2014-10-21     阅读数: 711
　　口服抗HBV药物对机体的免疫系统影响甚微，因而用它们治疗乙型肝炎很难获得治愈。由于清除病毒需要机体产生强度适合的HBV特异性T细胞应答。着眼于T细胞的免疫治疗一直是研发的热点之一，理想中，这种方法或能提高治愈率。
　　法国研究者Perrine Martin等开发了一个新的免疫治疗药物，TG1050，使用非复制腺病毒5型载体编码一段独特的融合蛋白，包括3个主要病毒蛋白：截短的核心蛋白、修饰后的聚合酶和HBsAg结构域。
　　研究者们采用了IFN-γ-ELISPOT、细胞内因子染色、体内CTL试验、五聚体染色和记忆标志物染色等多种方法，检测注射TG1050后的naïve小鼠血、脾、肝脏内的T细胞应答。结果显示，TG1050能在3种naïve小鼠模型（HLA-A2小鼠，BALB/c小鼠和C57BL/6J小鼠）中诱导产生强烈、多特异性、多功能的持久T细胞应答。单次或多次皮下注射后，在naïve小鼠中，TG1050能诱导高水平的靶向核心蛋白、聚合酶和HBsAg结构域的T细胞。在脾脏和（或）肝脏中检测到大量分泌IFN-γ和（或）TNF-α的T细胞以及很强的体内溶细胞作用。
　　在T细胞应答的持久性方面，仅注射一次TG1050的小鼠体内在注射10个月后仍能检测到HBV特异性T细胞。这些细胞呈现出效益记忆细胞表型（CD44+/CD62L-），具有很强的回忆潜能（CD27+/CD43-）。
　　同时，研究者们还在HBV免疫耐受小鼠模型（AAV-HBV）中验证了TG1050在脾脏和肝脏中诱导产生功能T细胞的能力和对病毒的影响。免疫耐受小鼠单次注射TG1050后，可在脾脏和肝脏检测到持久的、分泌IFN-γ、TNF-α和IL-2的功能Ｔ细胞，而且不伴有ALT升高。有意思的是，在注射后2周内，观察到短暂的HBV病毒血症和HBsAg水平的控制。
　　据悉，目前TG1050已经进入了GMP生产程序。
标签： 热点聚焦 热点聚焦 乙肝

newchinabok

Transgene Announces Presentation of Data on TG1050 Immunotherapy against Chronic Hepatitis B and Provides Update on its Joint Venture with Tasly Pharmaceuticals in China

By
Published: July 1, 2014 11:45 a.m. ET

      
STRASBOURG, France, Jul 01, 2014 (BUSINESS WIRE) -- Regulatory News:

Transgene (TNG) today announced that it was invited to present existing preclinical data on its proprietary program against chronic hepatitis B, TG1050 immunotherapy, at the BIT 5th Annual International Symposium of Hepatitis in Dalian, China. The presentation, entitled, “TG1050, A Novel Viral-based Immunotherapeutic Targeting Chronic Hepatitis B Infection” was given by Dr. Ren Zhu, Senior Scientist and Head of the HBV Program at TRANSGENE Biopharmaceutical Technology (Shanghai) Co., Ltd, a Transgene subsidiary located in Shanghai, China.


The Company also provided an update on activities at the Company’s 50:50 equity joint venture (JV) with Tasly Pharmaceutical Group Co., Ltd. - Transgene Tasly (Tianjin) Biopharmaceutical Co., Ltd. The JV was set up to develop and commercialize innovative targeted immunotherapeutic products for the Chinese market. There are currently three projects ongoing at the joint venture: Transgene’s programs TG1050, TG3003, a monoclonal antibody to treat solid tumors and TG6002, an oncolytic viral immunotherapy to treat solid tumors. TG1050 is currently the JV’s most advanced program under development in China, with manufacturing process development ongoing and pre-clinical efficacy and toxicity studies anticipated to start later in 2014.

Xia MENG, General Manager of Transgene Tasly (Tianjin) Biopharmaceutical Co., Ltd. said: “We are pleased with the development progress we are making with TG1050, since we started activities in China with this immunotherapeutic product.Given the large unmet medical need in China to treat hepatitis B, we are excited about the potential TG1050 holds in helping to combat this disease.”

“We are delighted with the good work being done through our equity joint venture with Tasly Pharmaceutical Group to advance the development of TG1050, as well as other Transgene programs” said Philippe Archinard, Chairman and Chief Executive Officer of Transgene. “China is a growing market for biopharmaceuticals and we are excited to be playing a role in developing promising innovative therapeutics for this market that we hope will make a difference in patients’ lives.”

About TG1050
TG1050 is an adenovirus-based targeted immunotherapy candidate for the treatment of chronic hepatitis B.

An estimated 350-400 million people worldwide have chronic hepatitis B and 600,000 die of the disease every year. At present, hepatitis B is largely incurable and is responsible for a large number of cases of cirrhosis and liver cancer. While the current standard of care, antiviral treatments, enable patients to stabilize their disease, the cure rate remains unsatisfactory, ranging from 3-25 % depending on the patient population. Thus, there is a large unmet medical need for new and alternative treatments.

In China, there are an estimated 70 million people living with chronic hepatitis B, and the country has a large public health initiative underway to significantly increase the number of patients diagnosed and treated with the disease.

The pre-clinical package for TG1050 supports the capacity of TG1050 to induce robust, broad, long-lasting T cells with characteristics similar to those found in patients who resolve infection, together with some antiviral activity. Importantly, TG1050–educated T cells have the capacity to recognize immune determinants derived from all circulating strains of HBV viral genotypes, including genotypes B and C that are dominant in China. In addition, a collaborative study performed between the Ruijin Hospital in Shanghai and both Transgene Biopharmaceutical Technology (Shanghai) Co., Ltd. and Transgene SA, showed that levels of antibodies to adenovirus are similar in chronic hepatitis B infected patients and healthy volunteers.1
Transgene expects to initiate a first-in-humans clinical trial outside of China in late 2014.

TG1050 is also being developed for the Chinese market by Transgene Tasly (Tianjin) Biopharmaceutical Co., Ltd., a 50:50 equity joint venture between Transgene and Tasly Pharmaceutical Group Co., Ltd.

About Transgene in China:
TRANSGENE Biopharmaceutical Technology (Shanghai) Co. Ltd was established in 2012 and is a Wholly Foreign Owned Enterprise (“WOFE”) under the laws of the People’s Republic of China. Research activities conducted by Transgene through this subsidiary are mainly academic and early stage. Development and eventual commercialization of Transgene’s more mature R&D programs for the Chinese market will be conducted through Transgene Tasly (Tianjin) Biopharmaceutical Co. Ltd, the 50:50 joint-venture formed in 2010 by Transgene with the Chinese pharmaceutical group, Tianjin Tasly Pharmaceutical Co. Ltd.

About Transgene:
Transgene (nyse-euronext:TNG), a member of the Institut Mérieux Group, is a publicly traded French biopharmaceutical company focused on discovering, developing and manufacturing targeted immunotherapies for the treatment of oncology and infectious diseases. Transgene’s programs utilize well-tolerated viruses with the goal of indirectly or directly killing infected or cancerous cells. The Company’s two lead clinical-stage programs are: TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. The Company has several other programs in clinical and pre-clinical development that are based on its core viral vector technology; this includes clinical-stage TG4001 for oropharyngeal cancer and TG1050 for hepatitis B in advanced pre-clinical development. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as satellite offices in China and the U.S. Additional information about Transgene is available at www.transgene.fr.

Disclaimer:
This press release contains forward-looking statements about the future development of TG1050 and the Company’s activities in China. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product development and commercialization, and marketing approval by government regulatory authorities.For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Document de Référence, which is available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.fr).

1 The adenovirus-backbone is an important component of TG1050 in particular due to its self-adjuvant properties. Assessing antibodies to the TG1050 adenovirus-backbone in the targeted population of chronic hepatitis B patients is important to allow for optimal design of first-in-human studies.

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SOURCE: Transgene

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newchinabok

转基因宣布演示数据在TG1050对慢性乙型肝炎免疫治疗，并提供了其合资公司与天士力制药公司在中国的更新

通过
发布时间：2014年7月1日上午11时45 ET

      
法国斯特拉斯堡，2014年7月1日（美国商业资讯） - 监管新闻：

转基因（TNG）今天宣布，该公司应邀出席现有的临床数据在其对慢性乙型肝炎，TG1050专有的免疫程序，在比特第五届国际肝炎在中国大连研讨会。演示文稿，题为“TG1050，一种新型病毒为基础的免疫治疗针对慢性乙肝感染者”由朱韧博士，资深科学家和HBV项目负责人TRANSGENE生物医药技术（上海）有限公司，转基因被赋予子公司设在中国上海。


转基因，天士力（天津）生物制药有限公司合资成立了开发和商业化 - 本公司亦于本公司50:50合资公司（JV）与天士力制药集团有限责任公司提供的最新的活动创新有针对性的免疫治疗产品的中国市场。目前有三个项目正在进行的合资公司：转基因的节目TG1050，TG3003，单克隆抗体治疗实体瘤和TG6002，溶瘤病毒免疫疗法来治疗实体肿瘤。 TG1050是目前合资公司正在开发中的中国最先进的方案，预计将在2014年后开始制造工艺的发展和持续的临床前药效和毒性研究。

夏梦，转基因，天士力（天津）生物制药有限公司总经理，公司表示：“我们很高兴能与我们正在与TG1050的开发进度，因为我们开始在中国的活动与该免疫product.Given大未满足的医疗需求在中国治疗乙肝，我们很高兴能有潜力TG1050拥有帮助对抗这种疾病。“

“我们很高兴与良好的工作，通过我们与天士力制药集团股权的合资企业正在做推进TG1050的发展，以及其他转基因项目”菲利普Archinard，董事长和转基因的首席执行官说。 “中国是一个不断增长的市场生物制药，我们很高兴能够发挥开发这个市场，我们希望以此使患者的生活带来改变有前途的创新型疗法的作用。”

关于TG1050
TG1050是腺病毒为基础的靶向免疫治疗的候选慢性乙型肝炎的治疗

估计有350-400万人在全球有慢性B型肝炎，每年60万死于该病。目前，乙型肝炎主要是不可治愈的，负责大量肝硬化和肝癌病例。虽然保健，抗病毒治疗的现行标准，让患者以稳定他们的疾病，治愈率仍然不理想，从3-25％取决于病人的人口。因此，存在对新的和替代处理大量尚未满足的医疗需求。

在中国，估计有7000万人患有慢性乙型肝炎，并在全国拥有庞大的公共卫生行动正在进行显著增加患者诊断和治疗的疾病数量。

临床前软件包TG1050支持TG1050的诱导健壮，宽峰，持久性T细胞以类似于在病人谁解决感染发现的特性，与一些抗病毒活性在一起的能力。重要的是，TG1050教育的T细胞具有识别从乙肝病毒基因型所有流行株，其中包括占主导地位的中国基因型B和C的派生免疫因素的能力。此外，合作研究的瑞金医院之间在上海进行，这两种转基因生物医药技术（上海）有限公司和转基因SA，发现抗体水平，以腺病毒是慢性乙肝感染患者和健康volunteers.1相似
转基因预计将在2014年年底启动先入人体临床试验在中国之外。

TG1050也正在通过转基因，天士力（天津）生物制药有限公司，转基因，天士力制药集团有限责任公司以50:50的比例合资开发中国市场

关于转基因在中国：
TRANSGENE生物医药技术（上海）有限公司成立于2012年，是一家外商独资企业（“外商独资企业”）根据中国人民共和国的法律。通过转基因通过这家子公司进行的研究活动主要是学术和起步阶段。对转基因的较为成熟的研发项目，为中国市场开发和商业化最终将通过转基因，天士力（天津）生物制药有限公司，成立于2010年转基因与中国医药集团，天津天士力制药股份有限公司的50:50合资进行。公司

关于转基因：
转基因（纽约证券交易所，泛欧证券交易所：TNG），研究所梅里埃集团的成员之一，是一家上市的法国生物制药公司，主要致力于发现，开发和生产有针对性的免疫疗法对肿瘤和感染性疾病的治疗。转基因的方案利用具有良好耐受性的病毒具有的间接或直接杀死受感染的细胞或癌细胞的目的。公司的两大领先于临床阶段的方案是：TG4010用于非小细胞肺癌和Pexa-VEC为肝癌。本公司已在基于其核心病毒载体技术的临床和临床前开发一些其他的方案;这包括临床阶段的TG4001在先进的临床前开发口咽癌及TG1050为乙型肝炎。转基因是总部设在法国的斯特拉斯堡，并在里昂在中国的其他业务，以及卫星办事处和www.transgene.fr关于转基因在美国的其他资料。

免责声明：
本新闻稿包含前瞻性约TG1050的未来发展，该公司在中国的业务报表。尽管该公司认为其预期是基于合理的假设，这些前瞻性陈述受到众多风险与不确定性，可能导致实际结果与预期产生重大差异。任何这些风险的发生可能对本公司的活动，视角，财务状况，业绩和发展一个显著的负面结果。该公司的商业化产品的能力取决于但不限于以下因素：积极的临床前数据可能无法预测人类的临床效果，临床研究成功，获得融资和/或合作伙伴进行产品开发的能力和商业化，并通过政府的销售许可的监管authorities.For风险和不确定性，可能导致公司的实际结果，财务状况，业绩或成就与这些包含的前瞻性陈述以不同的讨论，请参考风险因素（“Facteurs德有伤风化”）的文件解引用，它可在AMF网站的部分（http://www.amf-france.org）或转基因的网站（www.transgene.fr）。

1所述的腺病毒骨架是TG1050特别的重要组成部分，由于其自身的佐剂特性。评估抗体的TG1050腺病毒骨架慢性乙型肝炎患者的目标人群是非常重要的，以便第一，在人类研究中的优化设计。

法国兴业ANONYME资本金去87.964.029,39€ - RC斯特拉斯堡B317540581
400大道Gonthier德安德纳赫 - 科特迪瓦公园创新 - CS80166 - 67405 ILLKIRCH格拉芬斯塔CEDEX（法国）