:) 本文来源于
http://www.agenusbio.com/Clinical Data Published in Vaccine Demonstrate Robust Immune Response with
Agenus’ Herpes Vaccine Containing QS-21 Adjuvant
Vaccine Adjuvant Combination Induces Both CD4+ and CD8+ T Cell Responses
considered critical in controlling herpes
Lexington, MA – September 26, 2011 – Agenus Inc. (Nasdaq: AGEN), a developer of
therapeutic vaccines for cancer and infectious diseases, today announced positive results
from a randomized, four-arm Phase 1 study of HerpV, a recombinant (off-the-shelf)
therapeutic vaccine for the treatment of genital herpes, which included the Company’s
proprietary QS-21 Stimulon® adjuvant. The results were published in the peer-reviewed
journal Vaccine.
HerpV is the most advanced HSV-2 vaccine currently in clinical development for the
treatment of genital herpes.
“This is the first evidence that a therapeutic genital herpes vaccine has elicited both CD4+
and CD8+ T-cell responses in humans,” said Anna Wald, MD, MPH, Professor of
Medicine, Epidemiology and Laboratory Medicine, University of Washington, Member,
Fred Hutchinson Cancer Research Center, and lead author of the manuscript. “We are
very encouraged by these clinical results as published literature suggest that cellular
immunity needs to be stimulated for successful treatment of genital herpes – a physically
painful and emotionally debilitating disease that affects one in six adults in the US.”
In this four-arm Phase 1 study, 35 herpes simplex virus type 2 seropositive patients
received the vaccine plus QS-21 (HerpV), vaccine without QS-21, QS-21 alone, or
placebo. Patients received three treatments at two-week intervals.
All patients who were evaluable for immune response and received HerpV showed a
statistically significant CD4+ T cell response (100%; 7/7) to HSV-2 antigens as detected
by IFNγ Elispot, and the majority of those patients demonstrated a CD8+ T cell response
(75%; 6/8). The vaccine was well tolerated, with injection site pain as the most
commonly reported adverse event.
Agenus plans to advance HerpV into a Phase 2 study in 2012 that will measure the effect
of vaccination on viral shedding in individuals infected with HSV-2. Experts in HSV-2
clinical research believe that a reduction in viral shedding could translate into clinical
benefit.
“The publication of our herpes vaccine results marks the beginning of an exciting
period,” stated Garo Armen, Ph.D., chairman and CEO of Agenus. “Over the next 18
months, we expect pivotal data from multiple important clinical programs that
incorporate QS-21, which are being developed by our corporate partners.”
The HerpV study results appear in an article titled “Safety and immunogenicity of long
HSV-2 peptides complexed with rhHsc70 in HSV-2 seropositive persons,” which is
available online at
http://www.sciencedirect.com/science/journal/aip/0264410X.
Earlier this year, the results of preclinical studies of HerpV were also published in
Vaccine in a separate manuscript titled, “A heat shock protein based polyvalent vaccine
targeting HSV-2: CD4(+) and CD8(+) cellular immunity and protective efficacy.”
About Herpes
According to the Centers for Disease Control, genital herpes affects more than 60 million
Americans—or 1 in 6 people between ages 14 and 49—with an additional 1.5 million
new cases each year.1 This disease often results in recurrent painful sores in the genital
area.2 The emotional consequences of genital herpes are quite significant, as 82 percent
of people in the study reported depression, 75 percent experienced fear of rejection, 69
percent cited feelings of isolation and 55 percent reported fear of discovery -- all due to
infection.3 Current therapies involve taking a daily medication that only partly
suppresses the virus.
About HerpV
HerpV is a recombinant therapeutic vaccine for the treatment of genital herpes, which is
caused by the herpes simplex virus-2 (HSV-2). The vaccine is based on Agenus' heat
shock protein (HSP) platform technology, and contains Agenus’ proprietary adjuvant QS-
21 Stimulon® adjuvant. HSPs, also called stress proteins, are found in all cells (normal
cells, cancer cells and infected cells) and recent research has demonstrated that HSPs play
an essential role in the presentation of pieces of proteins (or peptides) on the cell surface
to help the immune system recognize diseased cells. While the initial focus of
development has been in HSV-2, the HSP technology platform can potentially be utilized
for off-the-shelf treatment of many types of infectious diseases such as HPV, HIV,
hepatitis, malaria and tuberculosis.
HerpV consists of recombinant human heat shock protein-70 complexed with 32 distinct
35-mer synthetic peptides from the HSV-2 proteome. This broad spectrum of herpes
antigens is intended to allow for more accurate immune targeting and surveillance,
reducing the likelihood of immune escape. Further, the diversity of antigens in HerpV
increases the chance of providing efficacy for a wide segment of the patient population.
About QS-21 Stimulon Adjuvant
QS-21 is a vaccine adjuvant designed to strengthen the body's immune response to a
vaccine's antigen, thus making it more effective. QS-21 has become a critical component
in the development of investigational preventive vaccine formulations across a wide
variety of infectious diseases, and appears to be essential for several investigational
therapeutic vaccines intended to treat cancer and degenerative disorders. Currently, QS-
21 is being studied in clinical trials in approximately 15 vaccine indications, of which
1
Genital
Herpes
- ‐
CDC
Fact
Sheet;
http://www.cdc.gov/std/herpes/stdfact- ‐herpes.htm#common;
accessed
July
19,
2010
2
Herpes
Virus;
http://www.herpesonline.org/articles/herpes_virus.html;
accessed
July
19,
2010
3
ASHA survey of people infected with herpes.
http://www.thefreelibrary.com/STUDY+SHOWS+GENITAL+HERPES+CAUSES+SIGNIFICANT+EMOTIONAL+STRESS+- ‐- ‐...-‐
a013131235
four are in Phase 3 studies by Agenus' licensees, which include GlaxoSmithKline and
Janssen Alzheimer Immunotherapy, a wholly owned subsidiary of Johnson & Johnson
and Integrated Biotherapeutics. QS-21 represents the most advanced adjuvant currently in
clinical development.
About Agenus
Agenus Inc. is a biotechnology company working to develop treatments for cancers and
infectious diseases. The company is focused on immunotherapeutic products based on
strong platform technologies with multiple product candidates advancing through the
clinic, including several product candidates that have advanced into late-stage clinical
trials through corporate partners. For more information, please visit
www.agenusbio.com.
Forward-Looking Statement
This press release contains forward-looking statements, including statements regarding
clinical trial activities, the publication of data, and the potential application of the
Company’s product candidates in the prevention and treatment of diseases. These
forward-looking statements are subject to risks and uncertainties that could cause actual
results to differ materially. These risks and uncertainties include, among others, the
factors described under the Risk Factors section of our Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission for the period ended June 30, 2011.
Agenus cautions investors not to place considerable reliance on the forward-looking
statements contained in this release. These statements speak only as of the date of this
document, and Agenus undertakes no obligation to update or revise the statements. All
forward-looking statements are expressly qualified in their entirety by this cautionary
statement. Agenus’ business is subject to substantial risks and uncertainties, including
those identified above. When evaluating Agenus’ business and securities, investors
should give careful consideration to these risks and uncertainties.
Stimulon is a registered trademark of Agenus Inc. and its subsidiaries.
Contact:
Jonae R. Barnes, 617-818-2985
###
:) 用GOOGLE翻译内容如下：
在疫苗临床数据表明强烈的免疫反应
Agenus“疱疹疫苗QS - 21辅助
疫苗佐剂组合诱导的CD4 +和CD8 + T细胞的反应
关键控制疱疹
列克星敦，马 - 2011年9月26日 - Agenus公司（纳斯达克股票代码：AGEN）的开发
癌症和传染性疾病的治疗性疫苗，今天宣布了积极的成果
一项随机，四臂1期研究HerpV，重组（现成的，现成的）
生殖器疱疹的治疗，其中包括该公司的治疗性疫苗
专有的QS - 21 Stimulon ®辅助。该研究结果发表在同行评审
杂志疫苗。
HerpV是最先进的HSV - 2疫苗的临床开发，目前为
生殖器疱疹的治疗。
他说：“这是第一个证据，生殖器疱疹的治疗性疫苗引起的CD4 +
和CD8 + T细胞在人类的回应，说：“安娜瓦尔德，医学博士，公共卫生硕士，教授
医学，流行病学和医学实验室，华盛顿大学，会员，
弗雷德哈钦森癌症研究中心，并导致作者的手稿。 “我们
非常鼓励通过这些临床结果发表的文献表明，蜂窝
免疫力需要刺激生殖器疱疹的治疗成功 - 一个物理
痛苦和情感衰弱的疾病，影响在6个美国成年人之一。“
在这四臂的第一阶段的研究中，35单纯疱疹病毒2型血清学阳性患者
疫苗加QS - 21（HerpV），疫苗无QS - 21，QS - 21单独或
安慰剂。每隔两个星期的患者接受三种治疗方法。
所有患者的免疫反应评价，并收到HerpV呈
统计学意义CD4 + T细胞反应（100％; 7 / 7）HSV - 2型抗原的检测
IFNγELISPOT，这些患者大多数表现出一个CD8 + T细胞的反应
（75％; 6 / 8）。这种疫苗耐受性良好，注射部位疼痛，作为最
常见的不良事件。
Agenus计划提前在2012年HerpV进入第2阶段的研究将测量效果
接种HSV - 2感染者的病毒脱落。专家HSV - 2
临床研究认为，在减少病毒脱落可能转化为临床
受益。
“我们的疱疹疫苗效果的出版，标志着一个激动人心的开始
期间，“加罗阿尔钦表示，博士，董事长兼首席执行官的Agenus。 “在未来18
几个月中，我们期望从多个重要的临床方案的关键数据，
纳入QS - 21，这是我们的企业合作伙伴开发。“
HerpV研究结果出现在一篇文章标题为“安全和长期的免疫原性
HSV - 2肽复合物在HSV - 2血清阳性的人“，这是与rhHsc70
可在网上
http://www.sciencedirect.com/science/journal/aip/0264410X。
今年早些时候，HerpV临床前研究结果也发表在
疫苗在一个单独的手稿题为“热休克蛋白基于多价疫苗
针对HSV - 2：CD4 +和CD8 +细胞免疫和保护效果“。
关于疱疹
据美国疾病控制中心，生殖器疱疹的影响超过60万
美国人或1 49 6 14岁之间的人与一个额外的150万
新发病例每个year.1这种病通常会导致生殖器经常痛苦的疮
area.2生殖器疱疹的情感后果是相当显著，高达82％
人们在研究报道抑郁症，75％的拒绝经验丰富的恐惧，69
％的人提到的孤立感和55％的人报告发现的恐惧 - 全因
infection.3目前的治疗涉及每天服用的药物，只是部分
抑制病毒。
关于HerpV
HerpV是生殖器疱疹的治疗，这是重组治疗性疫苗
由单纯疱疹病毒2型（HSV - 2）引起的。这种疫苗是基于Agenus“热
Agenus休克蛋白（HSP）平台技术，并包含“专利佐剂QS -
21 Stimulon ®辅助。热休克蛋白，也称为应激蛋白，被发现在所有细胞（正常
细胞，肿瘤细胞和感染细胞）和最近的研究表明，热休克蛋白发挥
在细胞表面上的重要作用提出的蛋白质碎片（或多肽）
帮助免疫系统识别病变细胞。虽然最初的重点
发展HSV - 2，HSP技术平台可能会被利用
的现成的种类很多，如人乳头状瘤病毒，艾滋病毒的传染性疾病的治疗，
肝炎，疟疾和肺结核。
HerpV包括重组人热休克蛋白70与32种不同的复合物
HSV - 2蛋白质的合成肽的35 - mer。这种疱疹的广谱
抗原是为了让更准确的免疫定位和监视，
降低免疫逃逸的可能性。此外，在HerpV多样性抗原
增加为宽段的患者人群的疗效的机会。
关于QS - 21 Stimulon佐剂
QS - 21是一种旨在加强人体的免疫响应的疫苗佐剂
疫苗的抗原，从而使其更加有效。 QS - 21已成为一个关键组成部分
在跨越广阔的发展研究预防性疫苗配方
各种传染病，并出现几个研究是必不可少的
用于治疗癌症和退化性疾病的治疗性疫苗。目前，QS -
21正在研究在约15个疫苗适应症，在临床试验中，其中
1
生殖器
疱疹
---
疾病预防控制中心
事实上
表;
http://www.cdc.gov/std/herpes/stdfact--herpes.htm＃常见的;
访问
七月
19，
2010
2
疱疹
病毒;
http://www.herpesonline.org/articles/herpes_virus.html;
访问
七月
19，
2010
3
阿沙与疱疹病毒感染的人的调查。
a013131235
四个Agenus“持牌人3期研究，其中包括葛兰素史克公司和
扬森阿尔茨海默病免疫的全资附属公司，强生公司
综合生物疗法。 QS - 21代表了目前最先进的辅助
临床开发。
关于Agenus
Agenus公司是一家生物技术公司合作开发用于癌症治疗和
传染病。该公司专注于基于免疫治疗产品
通过推进多个候选产品的强大的平台技术
诊所，其中包括一些产品已进入后期临床先进的候选人
试验通过企业合作伙伴。欲了解更多信息，请访问
www.agenusbio.com。
前瞻性声明
本新闻稿包含前瞻性陈述，包括有关的声明，
临床试验活动，公布数据，和潜在的应用
公司的产品在预防和治疗疾病的候选人。这些
前瞻性陈述受风险和不确定性可能导致实际
结果大不相同。这些风险和不确定性包括，除其他外，
根据“风险因素”部分中我们的季度报告的10 - Q表格中描述的因素
截至2011年6月30日，期间向美国证券交易委员会（SEC）提交。
Agenus告诫投资者不要对前瞻性相当依赖
在本新闻稿中包含的语句。这些陈述仅就截至本公告日期
文件，并Agenus不承担任何义务更新或修改的报表。所有
本警示性，前瞻性陈述明示全部合格
语句。 Agenus“业务是受到相当大的风险和不确定性，包括的
这些上述确定。当评估Agenus“业务和证券投资者
应慎重考虑到这些风险和不确定性。
Stimulon是Agenus公司及其子公司的注册商标。
联系方式：
Jonae R ·巴恩斯，617-818-2985
＃＃＃
