展示的SB 9200，用于治疗乙型肝炎病毒（HBV），EASL）™2015年

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MILFORD, Mass., April 13, 2015 /PRNewswire/ -- Spring Bank Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, today announced two poster presentations on SB 9200, its lead drug candidate for the treatment of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infections, at The International Liver Congress™ 2015, 50th annual meeting of the European Association for the Study of the Liver (EASL), taking place April 22-26, in Vienna, Austria.

"We are very pleased to have been selected to present our HBV preclinical data and HCV Phase I data at the upcoming EASL meeting," said Radhakrishnan (Kris) Iyer, Ph.D., Chief Scientific Officer of Spring Bank.  "This congress affords us the opportunity to highlight our drug development programs in two difficult-to-treat viral infections to the worldwide medical and scientific communities."

Details of Spring Bank's presentations are below:

Poster Presentation

Title: Antiviral Efficacy and Induction of Host Immune Responses with SB 9200, an Oral Prodrug of the Dinucleotide SB 9000, in the Woodchuck Model of Chronic Hepatitis B Virus (HBV) Infection  
Date and Time: Saturday, April 25, 2015, 12:30 pm – 1:00 pm CEST  
Location: Hall B ePoster Area  
Abstract Number: P0636  
Session Info: Viral hepatitis: Hepatitis B & D – c. Clinical (Therapy, new compounds, resistance)

An oral presentation of the poster will also be made by Dr. Stephan Menne, Research Associate Professor at the Department of Microbiology & Immunology, Georgetown University Medical Center
Date and Time: Saturday, April 25, 2015, 12:30 pm – 1:00 pm CEST
Location: Hall B ePoster Area
ePoster screen: C-01

Late Breaker

Title: SB 9200, A Novel Immunomodulator for Patients with Viral Hepatitis: Phase 1 MAD Study in patients with Hepatitis C Virus (HCV) Infection  
Date and Time: Saturday, April 25, 2015, 3:30 pm – 4:00 pm CEST  
Location: Hall B ePoster Area

About European Association for the Study of the Liver (EASL)

Since 1966, when the association was founded, EASL has continued to grow from a small organisation that played host to 70 participants at its first meeting, to becoming the leading liver association in Europe. EASL attracts the foremost hepatology experts as members and has an impressive track record in promoting research in liver disease, supporting wider education, and promoting changes in European liver policies. For more information about EASL, please visit https://ilc-congress.eu/.

About SB 9200

SB 9200, derived from Spring Bank's proprietary Small Molecule Nucleic Acid Hybrid (SMNH) technology platform, is a novel anti-viral agent that uniquely acts by modulating the host immune response to viral infections through activation of the intracellular sentinel proteins RIG-I and NOD2. SB 9200 is being developed for the treatment of chronic hepatitis B and C and other viral infections.

About Spring Bank Pharmaceuticals

Spring Bank Pharmaceuticals is a clinical stage biopharmaceutical company. Based on its proprietary SMNH chemistry platform, Spring Bank is developing a pipeline of products representing a new class of pharmaceuticals with a wide range of applications. These rationally designed molecules combine the selectivity of naturally occurring nucleotides with the drug-like properties of classical pharmaceuticals.  The SMNHs have the properties of oral delivery, good pharmacokinetic profile, low side effects and ease of manufacture. The Company's most advanced clinical candidate, SB 9200, is a potential breakthrough drug for the treatment for HBV, HCV and other viral diseases. SB 9200 has a novel mechanism of action that involves modulation of the host immune response in the presence of viral infection.

Note Regarding NIH-Funded Research

Certain studies mentioned in this press release were partly supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R01AI094469 and NIAID contract laboratories. The content of this press release is solely the responsibility of Spring Bank Pharmaceuticals and does not necessarily represent the official views of the National Institutes of Health.

Contact:

Douglas J. Jensen  
President and Chief Executive Officer, Spring Bank Pharmaceuticals  
(508) 473-5993 x105

Matthew Haines / Maeve Conneighton  
Argot Partners  
(212) 600-1902  
[email protected]  
[email protected]

newchinabok

MILFORD，马萨诸塞，2015年4月13日/新华美通/ - 春季银行制药公司是一家临床阶段的生物制药公司，开发创新疗法对病毒性感染的治疗，今天宣布推出两款海报展示的SB 9200，它的主角候选药物用于治疗乙型肝炎病毒（HBV）和丙型肝炎病毒（HCV）感染，在国际肝病会议™2015年，欧洲协会为肝脏（EASL）的研究第50届年会，发生4月22日至26日在维也纳，奥地利。

“我们非常高兴能够被选中在即将举行的EASL会议，提出我们的HBV临床数据和丙型肝炎病毒第一阶段的数据，”拉达克里希南（克里斯）艾耶，博士，春季银行的首席科学官说。 “本次大会为我们提供了机会，突出两个难以治疗病毒感染我们的药物开发计划，为全球医疗界和科学界。”

春季银行的介绍详细信息如下：

海报展示

标题：抗病毒疗效和归纳宿主免疫应答与SB 9200，二核苷酸SB 9000的口服药物前体，慢性乙型肝炎病毒的土拨鼠模型（HBV）感染
日期和时间：周六，2015年4月25日，下午12点半 - 下午1时00分CEST
地点：B馆ePoster区
摘要编号：P0636
会议信息：病毒性肝炎：肝炎B＆D - C。临床（治疗，新的化合物，电阻）

海报的口头报告也将史蒂芬Menne博士，副研究员教授微生物学与免疫学系，乔治敦大学医学中心做
日期和时间：周六，2015年4月25日，下午12:30 - 下午1:00 CEST
地点：B馆ePoster区
ePoster屏：C-01

晚断路器

标题：SB 9200，一种新型的免疫调节病毒性肝炎患者：患者第1阶段MAD研究丙型肝炎病毒（HCV）感染
日期和时间：周六，2015年4月25日，下午3:30 - 下午4:00 CEST
地点：B馆ePoster区

关于欧洲协会为肝脏的研究（EASL）

自1966年以来，在该协会成立后，EASL继续从该接待了70名第一次会议，成为欧洲领先的肝病协会小型组织成长。 EASL吸引了最重要的肝病专家为成员，并在促进研究肝病，支持更广泛的教育，促转变，在欧洲肝脏政策令人印象深刻的记录。有关EASL的更多信息，请访问https://ilc-congress.eu/。

关于SB 9200

SB 9200，从春季银行的专有小分子核酸杂交（SMNH）技术平台获得，是一种新型的抗病毒剂，它唯一的作用，通过激活细胞内的前哨蛋白RIG-I和NOD2的调制到病毒感染宿主的免疫反应。 SB 9200正在开发用于治疗慢性乙型肝炎和丙型肝炎和其他病毒感染的治疗。

关于春季银行制药

春季银行药业是一家临床阶段的生物制药公司。基于其专有SMNH化学平台上，春季银行正在开发的产品代表了一类新的药物具有广泛的应用的管道。这些合理设计分子结合天然存在的核苷酸与经典药物的药物样性质的选择性。所述SMNHs有口服递送，良好的药物动力学特性，低副作用和易于制造的属性。该公司的最先进的临床候选人，SB 9200，是一个潜在的突破药物用于治疗乙肝，丙肝等病毒性疾病。 SB 9200具有行动涉及在病毒感染的存在的宿主免疫应答的调节的新机制。

注意关于NIH资助的研究

本新闻稿中提及的某些研究由国家过敏研究所和美国国立卫生研究院在奖号R01AI094469和NIAID的合同实验室传染病被部分支持。本新闻稿中的内容完全是春季银行药品的责任，并不一定代表美国国立卫生研究院的官方意见。

联系方式：

道格拉斯·J·詹森
总裁兼首席执行官，春季银行制药
（508）473-5993 X105

马修·海恩斯/梅芙Conneighton
隐语合作伙伴
（212）600-1902
[email protected]
[email protected]

newchinabok

有结果

zgct

原理是什么？核苷类？

StephenW

P0636
ANTIVIRAL EFFICACY AND INDUCTION OF HOST IMMUNE
RESPONSES WITH SB 9200, AN ORAL PRODRUG OF THE
DINUCLEOTIDE SB 9000, IN THE WOODCHUCK MODEL OF
CHRONIC HEPATITIS B VIRUS (HBV) INFECTION
K. Korolowicz1, S. Czerwinski1, R. Iyer2, J. Skell2, J. Yang1, R. Tucker3,
S. Menne1. 1Microbiology and Immunology, Georgetown University
Medical Center, Washington, DC, 2Spring Bank Pharmaceuticals,
Milford, MA, 33Department of Comparative Medicine, Georgetown
University Medical Center, Washington, DC, United States
E-mail: [email protected]
Background and Aims: Activation of the viral sensor proteins, RIG-I
and NOD2, by viral nucleic acids results in the production of type I
IFNs and subsequent induction of ISGs and antiviral immune cells.
SB 9200, an oral prodrug of the dinucleotide SB 9000, activates
RIG-I and NOD2 by binding at the nucleotide binding domain of
both proteins. This interaction also inhibits the synthesis of viral
nucleic acids by steric blockage of the viral polymerase. The host
immune stimulating and direct antiviral activities of SB 9200 were
evaluated in the woodchuck model of chronic HBV infection. SB
9200 is being developed for the treatment of chronic hepatitis B
and C and has completed Phase I clinical trials in treatment-naive
HCV-infected patients.
Methods: Two groups of woodchucks with chronic woodchuck
hepatitis virus (WHV) infection (n = 5/group) were treated orally,
daily with SB 9200 for 12 weeks at doses of 15 or 30 mg/kg.
Endpoints included PK, PD, tolerability, and antiviral efficacy.
Results: Treatment with SB 9200 at two select dose levels
resulted in up to 4.2 and 2.2 log10 reductions in serum WHV
DNA or WHV surface antigen (WHsAg) loads, respectively, from
pretreatment level. Treatment was also associated with reduced
hepatic levels of WHV DNA (up to 41%), WHV cccDNA (up to
32%), and WHV RNA (up to 50%), lower hepatic expression of WHV
antigens, and reduced liver disease progression. Following cessation
of treatment, recrudescence of WHV replication was observed
in all woodchucks treated with 15 mg/kg, whereas woodchucks
administered 30 mg/kg had delays in the relapse of serum WHV
DNA and WHsAg. The development of an anti-WHs antibody
response was not observed. The antiviral effects were associated
with a dose-dependent induction of IFNs (IFN-a, IFN-b) and ISGs
(OAS-1, CXCL10, ISG15) in blood and liver. Prolonged SB 9200
administration at both dose levels was well tolerated with CBC,
hematology and serum biochemistry parameters all appearing
normal through the treatment period.
Conclusions: Oral administration of SB 9200 for 12 weeks in
woodchucks with chronic WHV infection resulted in marked
reductions in serum and hepatic levels of viral DNA, RNA, and
antigens that were associated with (or were a result of) the
induction of host immune responses. These results suggest that
SB 9200 can induce an antiviral immune response during chronic
active hepadnaviral infection that has the potential for a functional
cure in the treatment of chronic hepatitis B, most likely in
combination with approved anti-HBV drugs.

StephenW

P0636
抗病毒疗效和诱导宿主免疫的
与SB 9200，THE的口头前体药物响应
二核苷酸SB 9000，在土拨鼠模型
慢性乙型肝炎病毒（HBV）感染
K. Korolowicz1，S. Czerwinski1，R. Iyer2，J. Skell2，J.阳1，R. Tucker3，
S. Menne1。 1Microbiology和免疫学，乔治敦大学
医疗中心，华盛顿特区，2Spring银行制药，
米尔福德，MA，比较医学，乔治敦33Department
大学医学中心，华盛顿特区，美国
电子邮件：[email protected]
背景和目的：病毒传感器蛋白质的活化，RIG-I
及NOD2，由病毒核酸导致产生I型
干扰素和随后的感应的ISG和抗病毒的免疫细胞。
SB 9200，二核苷酸SB 9000的口服药物前体，激活
RIG-I和NOD2通过在核苷酸结合域结合
这两种蛋白质。这种相互作用也能抑制病毒合成
核酸由病毒聚合酶的位阻堵塞。主人
SB 9200的免疫刺激和直接抗病毒活动是
评估慢性HBV感染土拨鼠模型。 SB
9200被用于治疗慢性乙型肝炎的治疗开发
和C，并已完成了I期临床试验治疗过
HCV感染患者。
方法：两组土拨鼠慢性土拨鼠
肝炎病毒（WHV）感染（N = 5 /组）口服治疗，
每日用SB 9200 12周剂量为15或30毫克/公斤。
终点包括PK和PD，耐受性，和抗病毒效力。
结果：治疗SB 9200在两个选择剂量水平
造成了高达4.2和2.2 log10的降低血清WHV
DNA或WHV表面抗原（WHsAg）载荷，分别从
治疗前的水平。治疗也与降低相关
WHV DNA的（高达41％），WHV的cccDNA肝水平（高达
32％），和WHV核糖核酸（高达50％），WHV低肝表达
抗原，和降低的肝脏疾病的进展。以下停止
治疗时，观察到WHV复制的复发
在15毫克/千克治疗，而旱獭所有旱獭
服用30毫克/ kg的血清WHV的复发延迟
DNA和WHsAg。抗WHS抗体的发展
响应未观察到。被关联的抗病毒作用
用的剂量依赖性诱导干扰素（IFN-一个，IFN-b）和ISG的
（OAS-1，CXCL10，ISG15）在血液和肝脏。延长SB 9200
政府在这两种剂量水平耐受性良好，CBC，
血液和血清生化指标全部出现
正常通过治疗期。
结论：SB 9200的12周口服
土拨鼠慢性WHV感染后，标记
降低血清和病毒DNA，RNA的肝的水平，并
与被相关联的（或者的结果）抗原
诱导宿主免疫应答。这些结果表明，
SB 9200可诱导慢性期间的抗病毒免疫应答
活性嗜肝病毒感染具有潜力的官能
治愈慢性乙型肝炎的治疗，最有可能在
联合批准的抗HBV药物。

StephenW

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可以下载所有摘要:

https://ilc-congress.eu/scientific-info/abstracts/

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谢谢