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肝胆相照论坛 论坛 学术讨论& HBV English 好消息在乙肝患者中,TG1050良好的耐受性诱发强烈的特异 ...
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好消息在乙肝患者中,TG1050良好的耐受性诱发强烈的特异

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发表于 2017-10-23 19:50 |显示全部帖子
本帖最后由 newchinabok 于 2017-10-23 19:57 编辑

https://finance.yahoo.com/news/t ... rong-053000026.html

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发表于 2017-10-23 19:53 |显示全部帖子
TG1050 is Well Tolerated and Induces a Strong Specific Immune Response in Patients with Chronic Hepatitis B
        Business WireOctober 23, 2017
STRASBOURG, France--(BUSINESS WIRE)--
Regulatory News:

Transgene (TNG.PA), a biotech company that designs and develops viral-based immunotherapies, announces that the analyses conducted on patients with chronic hepatitis B receiving standard antiviral therapies and a single dose of TG1050 in the Phase 1/1b trial, confirm the good tolerability profile and demonstrate the immunogenicity of this novel therapeutic vaccine.
Transgene presented a poster describing the first promising clinical data of TG1050 on October 21, 2017, at the annual meeting of the AASLD (American Association for the Study of Liver Diseases) that is currently taking place in Washington, DC.
These results were obtained from the first cohort of patients included in the Phase 1/1b trial; patients that are currently treated with standard antiviral therapy also received a single dose of TG1050. The data presented further strengthen the first elements communicated in 20161, i.e. a very satisfying tolerability profile of TG1050. They also confirm the product’s mechanism of action.
The immunologic analyses show that TG1050 induces a specific immune response in the patients:
Strong immune responses against the different HBV antigens that are vectorized by TG1050 (core protein, polymerase and envelop protein – HbsAg) have been shown in the patients who received the two highest doses (1010 vp et 1011 vp);
A dose-effect relationship was observed in terms of number of patients developing responses against the different viral antigens, with a higher intensity of responses in the groups receiving the two highest doses (1010 vp et 1011 vp).
The abstract published in Hepatology can be downloaded on the AASLD website. The poster is accessible from Transgene’s website: www.transgene.fr.
Prof Fabien Zoulim, MD, PhD, principal investigator of the trial and head the gastro-enterology service of the Croix-Rousse Hospital (Lyon, France), commented: “Patients with chronic hepatitis B are currently treated over very long periods. They live with the risk of developing severe complications due to the disease and are expecting therapies that can cure them. The results obtained after a single injection of TG1050 are very promising and confirm the expected mechanism of action of this novel therapeutic vaccine. We are looking forward to presenting the full results of the trial at upcoming major international conferences dedicated to liver diseases.”
-End-
Notes to editors
About TG1050
TG1050 is a targeted immunotherapy candidate for the treatment of chronic hepatitis B, based on a viral vector expressing three HBV antigens. It is a therapeutic vaccine that has been designed and developed by Transgene’s antiviral research team. Preclinical results have demonstrated TG1050’s capacity to induce robust, broad, and long-lasting HBV-specific T cells with characteristics similar to those found in patients whose infection has been resolved. Antiviral effects of TG1050have also been shown2 3.
TG1050 is currently being evaluated in an international first-in-man Phase 1/1b trial in patients who are being treated for chronic HBV infection with standard-of-care antiviral therapies. This trial is randomized, multi-center, double-blind, and placebo-controlled. The primary objectives of the Phase 1/1b study are to evaluate the safety and tolerability of TG1050 administered in single and multiple doses and to determine the dose and schedule of TG1050 administration for further development. Secondary objectives correspond to the exploration of antiviral activity and immune responses to TG1050.
The technology of TG1050 is also being developed in China through Transgene’s joint-venture with Tasly Biopharmaceutical Technology, where it is currently under SFDA evaluation and has been recently granted an IND number. The latest publications on TG1050 are available on: www.transgene.fr.
About Chronic Hepatitis B
Hepatitis B is a potentially life-threatening liver disease caused by HBV infection. It puts patients at high risk of death from cirrhosis and liver cancer. Recent figures indicate the number of patients being treated for chronic hepatitis B was 200,000 in total in the United States, Germany, France, Italy, Spain and the United Kingdom and 100,000 patients in Japan. The eligible Chinese market represents 500,000 patients. Those numbers are expected to increase (Sources: ECDC- Incidence of Hepatitis B, Decision Resources: expert opinions). Currently available antiviral treatments can control the disease but not cure it. 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.
About Transgene
Transgene S.A. (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.

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发表于 2017-10-23 22:11 |显示全部帖子
这算头条信息了

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发表于 2017-10-24 05:13 |显示全部帖子
这个头条好消息翻译一下就好了

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发表于 2017-10-24 07:04 |显示全部帖子
又治不好乙肝,好个啥

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发表于 2017-10-24 07:32 |显示全部帖子
回复 kite2002005 的帖子

联合治疗提供了可能,比如abus的rnai药,治愈乙肝也有可能。

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发表于 2017-10-24 08:15 |显示全部帖子
TG1050我一直看好这个药,临床前的数据就表明能诱发抗体,现在看来在人体上一样有效,大赞!

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发表于 2017-10-25 09:10 |显示全部帖子
本帖最后由 hbv_challenger 于 2017-10-25 09:14 编辑

[size=1.3em]根据它发布的公告来讲, 如果有这么理想的效果,对于我们这些已经恩替变异的患者来讲,是一个非常大的利好, 乙肝治愈大有希望了..............................................................................
[size=1.3em]我记住了这个响亮的名字: TG1050, TG1050, TG1050, TG1050, TG1050, TG1050, TG1050...........
拉米(5年)耐藥,恩替(7年)耐藥, 2015.10.21服下第1顆替諾的超瘦大三羊,替诺进行时....

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发表于 2017-10-25 09:20 |显示全部帖子
刚刚上了其中方合作伙伴天津天士力的网站http://www.tasly.com 看了看, 这个公司的实力的确不太强, 做的都是一些很普通的药品,并且啥都做,连矿泉水都生产,希望不是一个带壳公司.
拉米(5年)耐藥,恩替(7年)耐藥, 2015.10.21服下第1顆替諾的超瘦大三羊,替诺进行时....

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发表于 2017-10-25 11:56 |显示全部帖子
        国内首个进入临床试验的慢性乙型肝炎腺病毒治疗性疫苗,市场空间广阔。7月14日,公司发布公告,公司收到CFDA核准签发的临床批件,批准公司乙型肝炎腺病毒注射液药物(T101)进行临床试验,T101是公司与法国Transgene的合资子公司天士力创世杰研发的产品,为国内首个以病毒为载体获批进入临床试验的慢性乙型肝炎治疗性疫苗,属于治疗用生物制品I类。我国慢性乙肝用药市场空间广阔,根据中国疾控中心2015年数据显示,我国HBV感染的人数约9000万人,其中慢性乙肝患者约2800万人,但在患病人群中,真正接受正常治疗的患者仅为200-250万人左右,所以,慢性乙肝药物市场依然具备较大的发展空间。与之对应,近年来乙肝市场规模不断扩容,从2011年的68.61亿元增长到2015年的162.76亿元,年复合增长率为22.4%,预计未来依旧能保持较快的增速。
  有望与核苷类药物联用,乙肝治疗有望实现新突破。与目前主流的核苷类抗乙肝药物不同,T101并不直接抑制HBV病毒的复制,而是通过诱导患者自身HBV抗原特异性的杀伤性T细胞,使其直接清除HBV病毒或诱导感染HBV病毒肝细胞凋亡,从而达到治疗慢性乙肝的目的。根据目前的临床结果,T101能长期、持续的诱导不同基因型HBV抗原特异性的杀伤性T细胞,该药后续如能获批上市,有望与核苷类抗乙肝药物联用,乙肝治疗有望实现新突破。
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