中国首例慢性乙型肝炎患者在T10 (Transgene 's TG1050技术)

newchinabok

https://finance.yahoo.com/news/f ... ient-164500912.html

windu

TG1050国内临床终于开始了吗？

antiHBVren

中国第一例慢性乙型肝炎患者T101（转基因TG1050技术）1期临床试验

法国STRASBOURG - （美国商业资讯） -

监管新闻：

设计和开发基于病毒的免疫疗法的生物技术公司Transgene（TNG.PA）（泛欧交易所巴黎代码：TNG）宣布，第一例患者已经在中国进行了一期临床试验，评估T101，一种基于转基因的免疫治疗技术用于治疗慢性乙型肝炎病毒（HBV）感染。该产品是一种病毒载体，表达与目前在欧洲和北美临床开发的TG1050相同的专利HBV抗原套件。

T101正在通过转基因与天士力制药集团有限公司的合资企业在中国开发。这家中国公司成立于2010年，在中国开发包括转基因产品在内的生物技术产品。该公司与位于中国天津的天士力制药集团有限公司（50％/ 50％）共同拥有。

第一阶段试验是一项随机，单中心，双盲，安慰剂对照研究，评估目前接受标准护理抗病毒治疗的慢性HBV感染患者的T101。本研究的主要目的是验证以单次和多次递增剂量给药的T101的耐受性。该试验还将评估特征与欧洲和北美患者特征不同的患者群体（例如不同的污染模式，不同的人群单体型）和谁可以感染不同的病毒基因型的患者人群中的治疗性疫苗的免疫原性。该试验将包括多达36名患者。研究的第一个数据预计在2019年初。

目前可用的抗病毒治疗可以控制慢性乙型肝炎，但不能治愈疾病。即使在长期治疗下，患者仍然很有可能发展为肝硬化和肝癌。在中国，50万患者可以从更好的治疗选择中受益。

基于表达三种HBV抗原的病毒载体，T101是用于治疗慢性乙型肝炎的靶向免疫治疗候选物。它是由转基因传染病研究小组根据转基因治疗性疫苗TG1050的技术设计的。
TG1050目前正在由Transgene在1 / 1b期临床试验中进行评估，TG1050在欧洲和加拿大接受标准治疗的抗病毒治疗的慢性HBV患者中进行。这个临床试验的第一个结果证实了TG1050的良好的耐受性。这项研究还显示了这种新型治疗性疫苗在接受标准抗病毒治疗的慢性乙型肝炎患者单次给药后的剂量相关免疫原性。预计接受多剂量TG1050的患者的其他数据将在2018年上半年召开的一次致力于肝病的重大国际会议上提交。

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注意编辑

关于转基因
Transgene（TNG.PA）是InstitutMérieux的一部分，是一家上市的法国生物技术公司，专注于设计和开发治疗癌症和传染病的靶向免疫疗法。转基因的方案利用病毒载体技术的目的是间接或直接杀死感染或癌细胞。公司临床阶段的主要项目有：针对非小细胞肺癌的治疗性疫苗TG4010，针对肝癌的溶瘤病毒Pexa-Vec和针对HPV阳性的头颈癌的治疗性疫苗TG4001。公司还有其他几个临床开发项目，包括TG1050（慢性乙型肝炎）和TG6002（实体瘤）。
转基因位于法国斯特拉斯堡，在里昂还有一家合资企业，在里昂也有业务。有关转基因的更多信息，请访问www.transgene.fr。

在Twitter上关注我们：@TransgeneSA

放弃
本新闻稿包含前瞻性陈述，这些陈述有许多风险和不确定因素，可能会导致实际结果与预期大不相同。无法保证（i）临床前工作和先前的临床试验的结果可以预测正在进行的临床试验的结果，（ii）监管机构将同意公司进一步的治疗发展计划，或（iii）本公司将及时并按照令人满意的条款和条件（如果有的话）寻找发展和商业化合作伙伴的治疗方案。任何这些风险的发生都可能对公司的活动，观点，财务状况，成果和发展产生重大的负面影响。
对于可能导致公司实际业绩，财务状况，业绩或业绩与前瞻性业务所载不同的风险和不确定因素的讨论

antiHBVren

First Chronic Hepatitis B Patient Dosed in China in a Phase 1 Trial of T101 (Transgene’s TG1050 Technology)

STRASBOURG, France--(BUSINESS WIRE)--

Regulatory News:

Transgene (TNG.PA) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies, announces that the first patient has been dosed in a Phase 1 clinical trial in China, evaluating T101, a therapeutic vaccine based on Transgene’s immunotherapy technology for the treatment of chronic hepatitis B virus (HBV) infection. This product is a viral vector expressing the same suite of patented HBV antigens as in TG1050, currently in clinical development in Europe and North America.

T101 is being developed in China through Transgene’s joint-venture with Tasly Pharmaceutical Group Co, Ltd. This Chinese corporation was created in 2010 to develop biotechnology products, including Transgene products, in China. This company is jointly owned (50%/50%) with Tasly Pharmaceutical Group Co, Ltd, which is based in Tianjin, China.

The Phase 1 trial is a randomized, single-center, double-blind, placebo-controlled study evaluating T101 in patients who are currently being treated for chronic HBV infection with standard-of-care antiviral therapy. The primary objective of this study is to validate the tolerability of T101 administered in single and multiple ascending doses. The trial will also evaluate the immunogenicity of the therapeutic vaccine in a patient population whose characteristics differ from European and North American patients (e.g. different modes of contamination, different population haplotypes), and who can be infected with different genotypes of the virus. This trial will include up to 36 patients. The first data readout from the study is expected at the beginning of 2019.

Currently available antiviral treatments can control the chronic hepatitis B but not cure the disease. Even under chronic treatment, patients still have a high probability to develop cirrhosis and liver cancer. In China, 500,000 patients could benefit from a better therapeutic option.

T101 is a targeted immunotherapy candidate for the treatment of chronic hepatitis B, based on a viral vector expressing three HBV antigens. It has been designed by Transgene’s infectious diseases research team, based on the technology of Transgene’s therapeutic vaccine TG1050.
TG1050 is currently being evaluated by Transgene in a Phase 1/1b trial with TG1050 in chronic HBV patients treated with standard-of-care antiviral therapies in Europe and Canada. The first results from this clinical trial have confirmed the good tolerability profile of TG1050. This study has also demonstrated the dose-related immunogenicity of this novel therapeutic vaccine following a single administration to patients with chronic hepatitis B receiving standard antiviral therapy. Additional data on patients receiving multiple doses of TG1050 are expected to be presented at a major international conference dedicated to liver diseases in H1 2018.

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Notes to editors

About Transgene
Transgene (TNG.PA), part of Institut Mérieux, is a publicly traded French biotechnology company focused on designing and developing 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 lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer, Pexa-Vec, an oncolytic virus against liver cancer, and TG4001, a therapeutic vaccine against HPV-positive head and neck cancers. The Company has several other programs in clinical development, including TG1050 (chronic hepatitis B) and TG6002 (solid tumors).
Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as a joint venture in China. Additional information about Transgene is available at www.transgene.fr.

Follow us on Twitter: @TransgeneSA

Disclaimer
This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. There can be no guarantee that (i) the results of pre-clinical work and prior clinical trials will be predictive of the results of the clinical trials currently underway, (ii) regulatory authorities will agree with the Company’s further development plans for its therapies, or (iii) the Company will find development and commercialization partners for its therapies in a timely manner and on satisfactory terms and conditions, if at all. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results and development.
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 st

kite2002005

忽悠群众

windu

这个在国外一期临床已经完成，不是忽悠