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IMMUNE FUNCTION EVALUATION METHOD AND ELISA SYSTEM THEREFOR

外国特許コード F190009803
整理番号 (S2017-1058-N0)
掲載日 2019年5月8日
出願国 世界知的所有権機関(WIPO)
国際出願番号 2018JP033161
国際公開番号 WO 2019049974
国際出願日 平成30年9月7日(2018.9.7)
国際公開日 平成31年3月14日(2019.3.14)
優先権データ
  • 特願2017-172593 (2017.9.8) JP
発明の名称 (英語) IMMUNE FUNCTION EVALUATION METHOD AND ELISA SYSTEM THEREFOR
発明の概要(英語) The purpose of the present invention is to develop a method capable of evaluating T-cell immune function. A method for evaluating T-cell immune function, said method characterized by detecting and quantifying soluble PD-L1 having a capacity for binding with PD-1. An ELISA system used for detecting and quantifying bsPD-L1, said system including: a means that includes a carrier with the solid-phased PD-1 protein thereon, and reacts the carrier and a test sample; and a means for detecting and quantifying, as bsPD-L1, soluble PD-L1 binded to the carrier.
従来技術、競合技術の概要(英語) BACKGROUND ART
T cell immune related disease condition, as well as cancer, infection, autoimmune disease, allergy, rejection at the time of implantation, and a wide range of life-style related diseases. Immune function of an individual is currently in clinical applications, in particular T cell function there is no evaluation means equal to. Current, are routinely performed in clinical blood as an index associated with an inspection, the number of white blood cells, white blood cell fractions, immunoglobulin, CRP and the like, of the individual inspection items are T cell function cannot be evaluated. T cell function in the molecule control, PD-1/known PD-L1.
The PD-1, T cells express a surface membrane protein or the like (Patent Document 1, 2). PD-1 as a ligand, identified and PD-L2 PD-L1 and, of these molecules in combination with T cell function PD-1 can be suppressed, to modulate the suppressed immune response are known. In addition, virus infection or cancer cells that express a ligand by PD-1, via binding of the PD-1, to escape from the host immune surveillance has been known.
One of the ligands of these PD-1 PD-L1 is, expressing the cell surface and the film type, is present in the blood is present in the soluble. Film type PD-L1 is, inhibition of decomposition by glycosylation N- stabilized, and increase the binding capacity of the PD-1 has been known (Non-Patent Document 1). On the other hand, in PD-L1 nonsupressor, glycosylated is what is known, the meaning is not apparent. The signal PD-1/PD-L1 have been developed as attention is paid to the agent, the antibody is anti-PD-1 nivolumab formulation (product name: opujibo) and the like.
Nivolumab is, in the molecule to inhibit immune checkpoint by PD-1, releases the brakes of the immune system, increased anti-tumor immune response against cancer effect. Nivolumab of the response rate, and from about 20 and 30%, a high sensitivity low patient group of patients is divided into a current. For predicting drug sensitivity in a variety of attempts have been made and, as one example, tumor tissue by examining the expression of a PD-L1, an attempt is made to make a diagnosis of whether or not the adaptation is. In addition, the anti-antibody treatment from the patient before and after the PD-1 using a blood sample, the blood is present in the PD-L1 nonsupressor PD-1 the therapeutic effect of the anti-biomarker antibody therapy may be distinguished and have been studied. In addition, the relationship between PD-L1 nonsupressor prognosis have been investigated. For example, non-small cell lung cancer patients in the test target 109 example, tissue in the same manner as PD-L1, the expression of the prognosis nonsupressor PD-L1 an inverse correlation (nonsupressor PD-L1 value group is compared with the low-value group and a poor prognosis) has been reported (Non-Patent Document 2). However, the expression of the prognosis of cancer in tissue and immune or PD-L1 checkpoint inhibitor will be described in the context of an overall response rate, consistent with the current view is not obtained in the (non-patent document 5 from 3). In addition, immunohistological examination, biopsy sampling portion of the engine and affected by variations in inspection, and quantification is standardized is difficult.
  • 出願人(英語)
  • ※2012年7月以前掲載分については米国以外のすべての指定国
  • UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH, JAPAN
  • NIPPON MEDICAL SCHOOL FOUNDATION
  • 発明者(英語)
  • IWAI, Yoshiko
  • TAKEUCHI, Masahiro
  • DOI, Tomomitsu
国際特許分類(IPC)

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