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标题: EASL2015:Transgene出新的TG1050数据 [打印本页]

作者: StephenW 时间: 2015-4-23 19:51 标题: EASL2015:Transgene出新的TG1050数据

Transgene Presents New Data with TG1050, an Immunotherapy Being Developed to Treat Chronic Hepatitis B, at The International Liver Congress™ 2015

Regulatory News:

Transgene SA (Paris:TNG) today announced that new pre-clinical data with TG1050, an immunotherapy being developed for the treatment of chronic hepatitis B, were presented at The International Liver Congress™ 2015, the 50 Congress of the European Association for the Study of the Liver (EASL) in Vienna, Austria. The TG1050 data were presented as part of a Liver Immunology session in an oral presentation entitled: (Abstract O031).

The data presented today demonstrate the antiviral potential of TG1050 in a persistent hepatitis B virus (HBV) model. In this model, TG1050 was shown to significantly reduce circulating HBV DNA, to reduce the circulating HBV surface antigen (HBsAg), and to trigger seroconversion to HBsAg (i.e., to develop anti-HBsAg antibodies). The development of anti-HBsAg antibodies has been associated with HBV cure.

The presentation is available on Transgene’s website in the “Our Pipeline/Publications” section at .

"” said Eric Quéméneur, PhD, Executive Vice President and Vice President, Research & Development. “”

TG1050 is an adenovirus-based targeted immunotherapy candidate for the treatment of chronic hepatitis B, a potentially life-threatening liver infection caused by HBV infection. It can result in chronic infection and liver disease and, if left untreated, puts people at high risk of death from cirrhosis of the liver and liver cancer. Recent figures indicate the number of patients being treated for chronic hepatitis B was 150,000 in total in the United States, Germany, France, Italy, Spain and the United Kingdom and 200,000 patients in Japan. The eligible Chinese market represents 500,000 patients. Those numbers are expected to increase as more patients are diagnosed and treated for their disease.

Currently available antiviral treatments cure only an estimated 3% of cases, and patients in the developed world must take these treatments for an average of 15 years and often for their lifetime. Therefore, there is an urgent need to develop new therapeutic approaches to improve the cure rate.

The pre-clinical package for TG1050 has been completed, demonstrating the immunotherapy’s antiviral activity and the capacity of TG1050 to induce robust, broad, long-lasting and cross-reactive (i.e., capable of recognizing HBV strains from different genotypes) T cells with characteristics similar to those found in patients whose infection is resolved. Pharmaceutical development and pre-clinical toxicity studies have been completed. Transgene expects to begin patient enrollment in a first-in-humans clinical trial in mid-2015. The Company plans to first evaluate TG1050 in combination with standard of care anti-viral treatment with the aim of improving the cure rate. Additional development could include evaluating TG1050 in combination with immune checkpoint inhibitors and/or with novel classes of antivirals.

Transgene (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biopharmaceutical company focused on discovering, developing and manufacturing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene’s programs utilize viral vector technology 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. 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 .

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作者: StephenW 时间: 2015-4-23 19:51

转基因呈现出新的数据TG1050，免疫治疗正在研制治疗慢性乙型肝炎，在国际肝病会议™2015年

监管新闻：

转基因SA（巴黎：TNG）今天宣布，与TG1050，一种新的免疫治疗的临床前数据慢性乙型肝炎的治疗正在研制中，提出了在国际肝病会议™2015年，欧洲协会的50国会研究肝脏（EASL）在奥地利维也纳。在TG1050数据作为一个肝脏免疫学会议的口头陈述有权部分：（摘要O031）。

今天提出的数据表明TG1050的在持久性乙型肝炎病毒（HBV）模型中的抗病毒的潜力。在这种模式下，TG1050被证明显著降低循环的HBV DNA，以减小循环HBV表面抗原（HBsAg），并触发血清转换对HBsAg（即，开发出抗HBsAg抗体）。抗HBsAg抗体的开发已被乙型肝炎治疗相关联。

这次报告会是对转基因的网站的“我们的管道/刊物”部分中找到。

“”埃里克Quéméneur，博士，执行副总裁和副总裁，研发说。“”

TG1050为腺病毒为基础的靶向免疫治疗的候选为慢性乙型肝炎，一个潜在的威胁生命的肝脏感染乙型肝炎病毒造成的感染的治疗。它会导致慢性感染及肝脏疾病，并且如果不进行治疗，使人们在死亡从肝脏和肝癌的肝硬化高风险。最近的数据显示正在接受治疗的慢性乙肝患者人数在总在美国，德国，法国，意大利，西班牙和英国的20万患者在日本的15万。符合条件的中国市场代表了500,000名患者。预计这些数字增加，因为更多的患者被诊断和治疗的疾病。

目前可用的抗病毒治疗治愈病例估计只有3％，而患者在发达国家必须采取这些治疗的平均时间为15年，并经常为他们的一生。因此，目前迫切需要开发新的治疗方法，以提高治愈率。

临床前软件包TG1050已经完成，显示了免疫的抗病毒活性和TG1050的诱导能力健壮，宽，持久和交叉反应性（即，能够识别来自不同基因型的HBV株）T细胞与特征类似于在患者的感染已解决找到。药物的开发和临床前毒性研究已经完成。转基因预计将于耐心注册的先入人体临床试验在2015年中期。该公司计划先评估TG1050与关怀抗病毒治疗与提高治愈率的目标，标准组合。额外的开发可能包括与免疫检查点抑制剂和/或具有新的类抗病毒药物组合评估TG1050。

转基因（泛欧证券交易所：TNG），梅里埃研究所的一部分，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治疗癌症和传染性疾病的治疗。转基因的方案利用病毒载体技术的间接或直接杀死被感染的细胞或癌细胞的目的。公司的两大领先的临床阶段的方案是：TG4010用于非小细胞肺癌和Pexa-VEC肝癌。本公司有根据其核心病毒载体技术在临床和临床前开发一些其他程序。转基因是总部设在法国斯特拉斯堡，并在里昂在中国的其他业务，以及卫星办事处，有关转基因在美国的更多信息，请访问。

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作者: StephenW 时间: 2015-4-23 19:52

Oral Presentation at EASL2015:

http://www.transgene.fr/wp-conte ... Martin_21042015.pdf

作者: luckable 时间: 2015-4-23 20:08

StephenW 发表于 2015-4-23 19:51
转基因呈现出新的数据TG1050，免疫治疗正在研制治疗慢性乙型肝炎，在国际肝病会议™2015年

监管新闻：

现在的治愈率才3%。。。

作者: crysalechain 时间: 2015-4-23 20:13

luckable 发表于 2015-4-23 20:08
现在的治愈率才3%。。。

治愈率这么低？

作者: 战天斗hbv 时间: 2015-4-23 20:34

crysalechain 发表于 2015-4-23 20:13
治愈率这么低？

当然、不然大伙都嚷嚷着要所谓金牌、、、、

作者: 战天斗hbv 时间: 2015-4-23 20:36

The data presented today demonstrate the antiviral potential of TG1050 in a persistent hepatitis B virus (HBV) model. In this model, TG1050 was shown to significantly reduce circulating HBV DNA, to reduce the circulating HBV surface antigen (HBsAg), and to trigger seroconversion to HBsAg (i.e., to develop anti-HBsAg antibodies). The development of anti-HBsAg antibodies has been associated with HBV cure.
除了birinapant、第二种实验室实现hbsag血清学转换的药物？

作者: x321 时间: 2015-4-23 21:00

一点不拖泥带水的直接血清转换吗？渴望啊

作者: tonychant 时间: 2015-4-23 21:06

是动物实验还是临床实验数据？

作者: 战天斗hbv 时间: 2015-4-23 21:08

tonychant 发表于 2015-4-23 21:06
是动物实验还是临床实验数据？

我觉得肯定不是临床实验、不然早火了、、、、、

作者: StephenW 时间: 2015-4-23 21:16

回复 tonychant 的帖子

是, 预计人体临床试验在2015年中期.

作者: luckable 时间: 2015-4-23 21:36

战天斗hbv 发表于 2015-4-23 20:36
The data presented today demonstrate the antiviral potential of TG1050 in a persistent hepatitis B v ...

血清转换意味着功能治愈吗

作者: 战天斗hbv 时间: 2015-4-23 21:38

luckable 发表于 2015-4-23 21:36
血清转换意味着功能治愈吗

是、如果人体出现这种现象、就是功能治愈

作者: 呕卖膏滴 时间: 2015-4-24 09:05

临床前试验

作者: 呕卖膏滴 时间: 2015-4-24 09:18

new pre-clinical data with TG1050
临床前试验数据

作者: 无忌抗病毒 时间: 2015-4-24 10:43

天天看希望........

作者: 战天斗hbv 时间: 2015-4-24 10:55

无忌抗病毒发表于 2015-4-24 10:43
天天看希望........

先别看这个、这个明年的、今年birinapant要是cure了、这个不用登场了

作者: Zongguoyiren 时间: 2015-4-26 23:07

本帖最后由 Zongguoyiren 于 2015-4-26 23:10 编辑

第二匹黑马，作用原理跟birinapant类似？

作者: 战天斗hbv 时间: 2015-4-26 23:21

Zongguoyiren 发表于 2015-4-26 23:07
第二匹黑马，作用原理跟birinapant类似？

不同

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