This study will evaluate the maximum safe dose of the true human monoclonal antibody, 514G3, in the treatment of patients with Staphylococcus Aureus bacteremia. Preliminary evidence of efficacy will be evaluated as well. Patients will receive 514G3 plus antibiotics or placebo plus antibiotics in approximately a 3 to 1 ratio.

开始日期2015-05-01

申办/合作机构

XBiotech, Inc.

100 项与 514-G3 相关的临床结果

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100 项与 514-G3 相关的转化医学

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100 项与 514-G3 相关的专利（医药）

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项与 514-G3 相关的文献（医药）

PLOS ONE3区 · 综合性期刊

A natural human monoclonal antibody targeting Staphylococcus Protein A protects against Staphylococcus aureus bacteremia

3区 · 综合性期刊

ArticleOA

作者: Kwan, Tzu-Yu ; Cavalier, Michael C ; Bowling, Rodney A ; Lin, Jian ; Sunley, Kevin M ; Kuzmicheva, Galina A ; Varshney, Avanish K ; Shivaswamy, Sushma ; Martin, Rebecca L ; Rambhadran, Anu ; Simard, John ; Mays, Heather R ; Zhang, Yanfeng

Staphylococcus aureus can cause devastating and life-threatening infections. With the increase in multidrug resistant strains, novel therapies are needed. Limited success with active and passive immunization strategies have been attributed to S. aureus immune evasion. Here, we report on a monoclonal antibody, 514G3, that circumvents a key S. aureus evasion mechanism by targeting the cell wall moiety Protein A (SpA). SpA tightly binds most subclasses of immunoglobulins via their Fc region, neutralizing effector function. The organism can thus shield itself with a protective coat of serum antibodies and render humoral immunity ineffective. The present antibody reactivity was derived from an individual with natural anti-SpA antibody titers. The monoclonal antibody is of an IgG3 subclass, which differs critically from other immunoglobulin subclasses since its Fc is not bound by SpA. Moreover, it targets a unique epitope on SpA that allows it to bind in the presence of serum antibodies. Consequently, the antibody opsonizes S. aureus and maintains effector function to enable natural immune mediated clearance. The data presented here provide evidence that 514G3 antibody is able to successfully rescue mice from S. aureus mediated bacteremia.

100 项与 514-G3 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
菌血症	临床2期	美国	XBiotech, Inc.	2015-05-01
金黄色葡萄球菌菌血症	临床2期	美国	XBiotech, Inc.	2015-05-01
葡萄球菌感染	临床2期	-	XBiotech, Inc.	-