公开(公告)号：US20130309250A1

公开(公告)日：2013-11-21

申请号：US13892671

申请日：2013-05-13

Applicant: BRISTOL-MYERS SQUIBB COMPANY

Inventor： John Cogswell ,  Stacie M. Goldberg ,  Ashok K. Gupta ,  Maria Jure-Kunkel ,  Xi Tao Wang ,  John M. Wigginton

IPC: C07K16/28

CPC classification number: C07K16/2818 ,  A61K39/3955 ,  A61K2039/505 ,  A61K2039/507 ,  C07K16/18 ,  C07K16/2803 ,  C07K16/2827 ,  C07K2317/76 ,  G01N33/57492 ,  G01N2333/70596 ,  G01N2800/52 ,  Y02A50/41 ,  Y02A50/412

Abstract: The disclosure provides a method for immunotherapy of a subject afflicted with cancer, comprises administering to the subject a composition comprising a therapeutically effective amount of an antibody that inhibits signaling from the PD-1/PD-L1 signaling pathway. This disclosure also provides a method for immunotherapy of a subject afflicted with cancer comprising selecting a subject that is a suitable candidate for immunotherapy based on an assessment that the proportion of cells in a test tissue sample from the subject that express PD-L1 on the cell surface exceeds a predetermined threshold level, and administering a therapeutically effective amount of an anti-PD-1 antibody to the selected subject. The invention additionally provides rabbit mAbs that bind specifically to a cell surface-expressed PD-L1 antigen in a FFPE tissue sample, and an automated IHC method for assessing cell surface expression in FFPE tissues using the provided anti-PD-L1 Abs.

Abstract translation: 本公开提供了对患有癌症的受试者的免疫治疗的方法，包括向受试者施用包含治疗有效量的抗体的组合物，其抑制来自PD-1 / PD-L1信号传导途径的信号传导。 本公开还提供了对患有癌症的受试者进行免疫治疗的方法，包括选择作为免疫治疗的合适候选者的受试者，其基于评估来自在细胞上表达PD-L1的受试者的测试组织样品中的细胞比例 表面超过预定阈值水平，并向所选受试者施用治疗有效量的抗PD-1抗体。 本发明另外提供了与FFPE组织样品中的细胞表面表达的PD-L1抗原特异性结合的兔mAb，以及使用所提供的抗PD-L1抗体评价FFPE组织中的细胞表面表达的自动化IHC方法。

公开(公告)号：US09212224B2

公开(公告)日：2015-12-15

申请号：US13892671

申请日：2013-05-13

Applicant: Bristol-Myers Squibb Company

Inventor： John Cogswell ,  Stacie M. Goldberg ,  Ashok K. Gupta ,  Maria Jure-Kunkel ,  Xi Tao Wang ,  John M. Wigginton

IPC: C07K16/28 ,  A61K39/395 ,  C07K16/18 ,  G01N33/574 ,  A61K39/00

CPC classification number: C07K16/2818 ,  A61K39/3955 ,  A61K2039/505 ,  A61K2039/507 ,  C07K16/18 ,  C07K16/2803 ,  C07K16/2827 ,  C07K2317/76 ,  G01N33/57492 ,  G01N2333/70596 ,  G01N2800/52 ,  Y02A50/41 ,  Y02A50/412

Abstract: The disclosure provides a method for immunotherapy of a subject afflicted with cancer, comprises administering to the subject a composition comprising a therapeutically effective amount of an antibody that inhibits signaling from the PD-1/PD-L1 signaling pathway. This disclosure also provides a method for immunotherapy of a subject afflicted with cancer comprising selecting a subject that is a suitable candidate for immunotherapy based on an assessment that the proportion of cells in a test tissue sample from the subject that express PD-L1 on the cell surface exceeds a predetermined threshold level, and administering a therapeutically effective amount of an anti-PD-1 antibody to the selected subject. The invention additionally provides rabbit mAbs that bind specifically to a cell surface-expressed PD-L1 antigen in a FFPE tissue sample, and an automated IHC method for assessing cell surface expression in FFPE tissues using the provided anti-PD-L1 Abs.

Abstract translation: 本公开提供了对患有癌症的受试者的免疫治疗的方法，包括向受试者施用包含治疗有效量的抗体的组合物，其抑制来自PD-1 / PD-L1信号传导途径的信号传导。 本公开还提供了对患有癌症的受试者进行免疫治疗的方法，包括选择作为免疫治疗的合适候选者的受试者，其基于评估来自在细胞上表达PD-L1的受试者的测试组织样品中的细胞比例 表面超过预定阈值水平，并向所选受试者施用治疗有效量的抗PD-1抗体。 本发明另外提供了与FFPE组织样品中的细胞表面表达的PD-L1抗原特异性结合的兔mAb，以及使用所提供的抗PD-L1抗体评价FFPE组织中的细胞表面表达的自动化IHC方法。