公开(公告)号：US09696307B2

公开(公告)日：2017-07-04

申请号：US14603002

申请日：2015-01-22

Applicant: Biogen Idec MA Inc.

Inventor： Leonid Gorelik ,  Alexey Lugovskoy

IPC: G01N33/569 ,  C07K16/08 ,  G01N33/53

CPC classification number: G01N33/56983 ,  C07K16/081 ,  C07K2317/33 ,  G01N2333/025 ,  G01N2469/20 ,  G01N2800/28 ,  G01N2800/50 ,  G01N2800/52

Abstract: Methods and compositions for determining whether a subject is at risk for PML, including subjects being treated with immunosuppressants, by determining whether the subject harbors a JCV variant with reduced binding for sialic acid relative to a normal JCV, are presented. Furthermore, combinations of JCV-VP1 sequence variations that are associated with PML and that can be used as a basis of an assay for identifying subjects susceptible to PML, subjects with PML (e.g., early stage PML), or subjects at risk of developing PML in response to an immunosuppressive treatment are provided.

公开(公告)号：US20150219651A1

公开(公告)日：2015-08-06

申请号：US14603002

申请日：2015-01-22

Applicant: Biogen Idec MA Inc.

Inventor： Leonid Gorelik ,  Alexey Lugovskoy

IPC: G01N33/569

CPC classification number: G01N33/56983 ,  C07K16/081 ,  C07K2317/33 ,  G01N2333/025 ,  G01N2469/20 ,  G01N2800/28 ,  G01N2800/50 ,  G01N2800/52

Abstract: Methods and compositions for determining whether a subject is at risk for PML, including subjects being treated with immunosuppressants, by determining whether the subject harbors a JCV variant with reduced binding for sialic acid relative to a normal JCV, are presented. Furthermore, combinations of JCV-VP1 sequence variations that are associated with PML and that can be used as a basis of an assay for identifying subjects susceptible to PML, subjects with PML (e.g., early stage PML), or subjects at risk of developing PML in response to an immunosuppressive treatment are provided.

Abstract translation: 呈现用于确定受试者是否处于PML风险中的方法和组合物，包括用免疫抑制剂治疗的受试者，通过确定受试者是否携带具有减少的唾液酸相对于正常JCV的结合的JCV变体。 此外，与PML相关的JCV-VP1序列变异的组合可用作用于鉴定易受PML影响的受试者（例如早期PML）或具有发展PML风险的受试者的测定的基础 响应于免疫抑制治疗。

公开(公告)号：US20140213470A1

公开(公告)日：2014-07-31

申请号：US14086352

申请日：2013-11-21

Applicant: Genentech, Inc. ,  BIOGEN IDEC MA INC.

Inventor： Yen-Ming Hsu ,  Leonid Gorelik ,  Tatiana Novobrantseva ,  Joanne Quan ,  Flavius Martin ,  Susan L. Kalled

IPC: C12Q1/68 ,  G01N33/574 ,  G01N33/564 ,  G01N33/50 ,  G01N33/68

CPC classification number: C12Q1/6886 ,  C12Q1/6883 ,  C12Q2600/106 ,  G01N33/5041 ,  G01N33/564 ,  G01N33/57426 ,  G01N33/6872 ,  G01N2333/4706 ,  G01N2333/70539 ,  G01N2333/7056 ,  G01N2333/902 ,  G01N2800/52

Abstract: BAFF plays a central role in acquired immunity. The disclosure identifies BAFF responsive genes that are substantially upregulated by administration of BAFF and substantially downregulated by treatment with a BAFF antagonist. Specific genes are NF-κB2, CD23, H2-Mβ (the beta chain of H2-DM), Fig-1, and OBF-1. The disclosure provides methods and compositions for monitoring the activity of a BAFF antagonist in a mammal; monitoring BAFF activity in a mammal; identifying a mammal to be treated with a BAFF antagonist; and related uses. Such methods include detecting one or more molecules selected from the group consisting of Fig-1 molecule, OBF-1 molecule, and H2-Mβ molecule in a biological sample of the mammal, and optionally further detecting NF-κB2 molecule and/or CD23 molecule in the biological sample.

Abstract translation: BAFF在获得性免疫中起着核心作用。 本公开确定BAFF反应性基因，其通过施用BAFF基本上调，并且通过用BAFF拮抗剂治疗显着下调。 特定基因是NF-和Kgr; B2，CD23，H2-M＆bgr; （H2-DM的β链），图1和OBF-1。 本公开提供了用于监测哺乳动物中BAFF拮抗剂的活性的方法和组合物; 监测哺乳动物的BAFF活性; 鉴定要用BAFF拮抗剂治疗的哺乳动物; 和相关用途。 这样的方法包括检测选自图1分子，OBF-1分子和H 2 M＆amp; Bgr的一种或多种分子; 分子，并且任选地进一步检测生物样品中的NF-κB分子和/或CD23分子。