JP6674543B2 - 抗体に基づく薬物のコンパニオン診断としての細胞結合補体活性化産物アッセイ - Google Patents

抗体に基づく薬物のコンパニオン診断としての細胞結合補体活性化産物アッセイ Download PDF

Info

Publication number
JP6674543B2
JP6674543B2 JP2018525527A JP2018525527A JP6674543B2 JP 6674543 B2 JP6674543 B2 JP 6674543B2 JP 2018525527 A JP2018525527 A JP 2018525527A JP 2018525527 A JP2018525527 A JP 2018525527A JP 6674543 B2 JP6674543 B2 JP 6674543B2
Authority
JP
Japan
Prior art keywords
subject
level
disorder
autoimmune disease
biomarker
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
JP2018525527A
Other languages
English (en)
Japanese (ja)
Other versions
JP2018528439A5 (enExample
JP2018528439A (ja
Inventor
アハーン，ジョセフ，エム．
リュウ，チャウ−チン
マンズィ，スーザン，エム．
Original Assignee
アレゲーニー・シンガー リサーチ インスティチュート
アレゲーニー・シンガー リサーチ インスティチュート
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by アレゲーニー・シンガー リサーチ インスティチュート, アレゲーニー・シンガー リサーチ インスティチュート filed Critical アレゲーニー・シンガー リサーチ インスティチュート
Publication of JP2018528439A publication Critical patent/JP2018528439A/ja
Publication of JP2018528439A5 publication Critical patent/JP2018528439A5/ja
Application granted granted Critical
Publication of JP6674543B2 publication Critical patent/JP6674543B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/564—Immunoassay; Biospecific binding assay; Materials therefor for pre-existing immune complex or autoimmune disease, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/5044—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
    • G01N33/5047—Cells of the immune system
    • G01N33/5052—Cells of the immune system involving B-cells
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16Z—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
    • G16Z99/00—Subject matter not provided for in other main groups of this subclass
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701—Details
    • G01N2333/4716—Complement proteins, e.g. anaphylatoxin, C3a, C5a
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Rheumatology (AREA)
  • Rehabilitation Therapy (AREA)
  • Epidemiology (AREA)
  • Primary Health Care (AREA)
  • Databases & Information Systems (AREA)
  • Data Mining & Analysis (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Toxicology (AREA)
  • Pain & Pain Management (AREA)
  • Oncology (AREA)
JP2018525527A 2015-07-31 2016-07-29 抗体に基づく薬物のコンパニオン診断としての細胞結合補体活性化産物アッセイ Active JP6674543B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562199713P 2015-07-31 2015-07-31
US62/199,713 2015-07-31
PCT/US2016/044779 WO2017023781A1 (en) 2015-07-31 2016-07-29 Cell-bound complement activation product assays as companion diagnostics for antibody-based drugs

Publications (3)

Publication Number Publication Date
JP2018528439A JP2018528439A (ja) 2018-09-27
JP2018528439A5 JP2018528439A5 (enExample) 2019-09-05
JP6674543B2 true JP6674543B2 (ja) 2020-04-01

Family

ID=57885963

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2018525527A Active JP6674543B2 (ja) 2015-07-31 2016-07-29 抗体に基づく薬物のコンパニオン診断としての細胞結合補体活性化産物アッセイ

Country Status (7)

Country Link
US (1) US10067128B2 (enExample)
EP (1) EP3329278A4 (enExample)
JP (1) JP6674543B2 (enExample)
AU (1) AU2016303499B2 (enExample)
CA (1) CA2990722C (enExample)
IL (1) IL256618A (enExample)
WO (1) WO2017023781A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102604687B1 (ko) * 2017-02-01 2023-11-20 삼성전자주식회사 이미지 센서 및 그 제조 방법
AU2018333062B2 (en) 2017-09-15 2022-03-17 Beckman Coulter, Inc. Flow based assays for therapeutics

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4570872B2 (ja) 2001-09-10 2010-10-27 ユニヴァーシティ オブ ピッツバーグ 全身性紅斑性狼瘡および強皮症の診断およびモニタリング方法
US7588905B2 (en) 2003-04-16 2009-09-15 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Identification and monitoring of systemic lupus erythematosus
US8080382B2 (en) 2003-06-13 2011-12-20 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Monitoring immunologic, hematologic and inflammatory diseases
EP2214014A1 (en) * 2004-05-11 2010-08-04 The University of Pittsburgh Monitoring immunologic, hematologic and inflammatory diseases
WO2006133450A2 (en) * 2005-06-08 2006-12-14 Duke University Anti-cd19 antibody therapy for the transplantation
AU2009305575A1 (en) 2008-10-16 2010-04-22 Cypress Bioscience, Inc. Method for diagnosis and monitoring of disease activity and response to treatment in systemic lupus erythematosus (SLE) and other autoimmune diseases
WO2010054195A2 (en) 2008-11-07 2010-05-14 Centocor Ortho Biotech Inc. Markers and methods for assessing and treating lupus patients susceptible to photoprovocation
WO2011047337A2 (en) 2009-10-16 2011-04-21 Exagen Diagnostics, Inc. Cell-based complement activation product algorithm for diagnosing systemic lupus erythematosus
EP2673644B1 (en) 2011-02-11 2016-02-10 Exagen Diagnostics, Inc. Methods for diagnosing systemic lupus erythematosus
US9075069B2 (en) 2011-12-13 2015-07-07 Baxter International Inc. Measurement of autoantibodies at low conductivity with increased sensitivity
WO2014020357A1 (en) 2012-08-02 2014-02-06 Sense Proteomic Limited Auto-antigen biomarkers for lupus
WO2014093268A1 (en) 2012-12-10 2014-06-19 Allegheny-Singer Research Institute Methods and systems for using complement-tagged molecules as biomarkers of disease
CN111965358A (zh) * 2013-02-08 2020-11-20 阿勒格尼-辛格研究所 细胞结合的补体激活产物作为狼疮前期诊断性生物标志物
EP3092252B1 (en) * 2014-01-08 2019-09-18 The U.S.A. as represented by the Secretary, Department of Health and Human Services Antibody targeting cell surface deposited complement protein c3d and use thereof
RU2017107273A (ru) 2014-08-08 2018-09-10 Аллегени-Сингер Рисерч Инститьют Антилимфоцитарные аутоантитела в качестве диагностических биомаркеров

Also Published As

Publication number Publication date
WO2017023781A1 (en) 2017-02-09
AU2016303499A1 (en) 2018-02-01
US10067128B2 (en) 2018-09-04
EP3329278A4 (en) 2019-01-16
CA2990722C (en) 2022-07-05
US20170030905A1 (en) 2017-02-02
AU2016303499B2 (en) 2020-07-02
EP3329278A1 (en) 2018-06-06
JP2018528439A (ja) 2018-09-27
IL256618A (en) 2018-03-29
CA2990722A1 (en) 2017-02-09

Similar Documents

Publication Publication Date Title
Soriano et al. Levels of endothelial and platelet microparticles and their interactions with leukocytes negatively correlate with organ dysfunction and predict mortality in severe sepsis
Morel et al. Flow cytometric analysis reveals the high levels of platelet activation parameters in circulation of multiple sclerosis patients
Van Baarsen et al. The cellular composition of lymph nodes in the earliest phase of inflammatory arthritis
Kelton et al. A prospective comparison of four techniques for measuring platelet‐associated IgG
RS62155B1 (sr) Postupci predviđanja terapijske koristi anti-cd19 terapije kod pacijenata
Stradner et al. A combination of cellular biomarkers predicts failure to respond to rituximab in rheumatoid arthritis: a 24-week observational study
Rahman et al. Role of CD 200 in differential diagnosis of mature B‐cell neoplasm
Puñet‐Ortiz et al. Monitoring CD49d receptor occupancy: a method to optimize and personalize natalizumab therapy in multiple sclerosis patients
Suchanek et al. Immunophenotyping of putative human B1 B cells in healthy controls and common variable immunodeficiency (CVID) patients
Micsik et al. MDR-1 and MRP-1 activity in peripheral blood leukocytes of rheumatoid arthritis patients
von Essen et al. Immune reconstitution following alemtuzumab therapy is characterized by exhausted T cells, increased regulatory control of proinflammatory T cells and reduced B cell control
Tembhare et al. Evaluation of CD229 as a new alternative plasma cell gating marker in the flow cytometric immunophenotyping of monoclonal gammopathies
Park et al. Increased expression of immune checkpoint programmed cell death protein‐1 (PD‐1) on T cell subsets of bone marrow aspirates in patients with B‐Lymphoblastic leukemia, especially in relapse and at diagnosis
El Mahdaoui et al. Cerebrospinal fluid soluble CD27 is associated with CD8+ T cells, B cells and biomarkers of B cell activity in relapsing-remitting multiple sclerosis
Zingaropoli et al. JC virus‐DNA detection is associated with CD8 effector accumulation in peripheral blood of patients with multiple sclerosis under natalizumab treatment, independently from JC virus serostatus
AU2016303499B2 (en) Cell-bound complement activation product assays as companion diagnostics for antibody-based drugs
Wang et al. Comprehensive analysis of B cell repopulation in ocrelizumab-treated patients with multiple sclerosis by mass cytometry and proteomics
Guo et al. The role of neutrophils in skin damage induced by tissue‐deposited lupus IgG
Badrawy et al. Platelet antibodies, activated platelets and serum leptin in childhood immune thrombocytopenic purpura
CA3272948A1 (en) METHODS FOR PREDICTING AND TREATING IMMUNOTHERAPEUTIC TOXICITY BASED ON IMMUNE CELL POPULATIONS
US9709564B2 (en) Anti-lymphocyte autoantibodies as diagnostic biomarkers
Natalucci et al. Inclusion of fibrinoid necrosis increases the accuracy of synovial tissue assessment in predicting response to methotrexate: analysis of the UCLouvain Brussels ERA Cohort
Chen et al. False-positive light chain clonal restriction by flow cytometry in patients treated with alemtuzumab: potential pitfalls for the misdiagnosis of B-cell neoplasms
Abrahamsen et al. Differential mediator release from basophils of allergic and non‐allergic asthmatic patients after stimulation with anti‐IgE and C5a
Song et al. Expression of CD154 (CD40L) on stimulated T lymphocytes in patients with idopathic thrombocytopenic purpura

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180319

A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A525

Effective date: 20180319

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180626

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190723

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20190723

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20190723

A975 Report on accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A971005

Effective date: 20190808

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190910

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20191203

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20200107

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200109

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20200212

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20200306

R150 Certificate of patent or registration of utility model

Ref document number: 6674543

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250