JP2018528439A5 - - Google Patents
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- JP2018528439A5 JP2018528439A5 JP2018525527A JP2018525527A JP2018528439A5 JP 2018528439 A5 JP2018528439 A5 JP 2018528439A5 JP 2018525527 A JP2018525527 A JP 2018525527A JP 2018525527 A JP2018525527 A JP 2018525527A JP 2018528439 A5 JP2018528439 A5 JP 2018528439A5
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- autoimmune
- autoimmune disease
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- biomarker
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- 206010003816 Autoimmune disease Diseases 0.000 claims 17
- 201000009596 autoimmune hypersensitivity disease Diseases 0.000 claims 8
- 239000000090 biomarker Substances 0.000 claims 7
- 102000004965 antibodies Human genes 0.000 claims 6
- 108090001123 antibodies Proteins 0.000 claims 6
- 230000001225 therapeutic Effects 0.000 claims 6
- 102100010034 AKAP17A Human genes 0.000 claims 5
- 101710037404 AKAP17A Proteins 0.000 claims 5
- 210000003719 B-Lymphocytes Anatomy 0.000 claims 4
- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 4
- 208000003950 B-Cell Lymphoma Diseases 0.000 claims 3
- 210000004369 Blood Anatomy 0.000 claims 2
- -1 CD79 Proteins 0.000 claims 2
- 206010039073 Rheumatoid arthritis Diseases 0.000 claims 2
- 206010040767 Sjogren's syndrome Diseases 0.000 claims 2
- 206010042953 Systemic sclerosis Diseases 0.000 claims 2
- 206010047115 Vasculitis Diseases 0.000 claims 2
- 239000008280 blood Substances 0.000 claims 2
- 201000003278 cryoglobulinemia Diseases 0.000 claims 2
- 201000002481 myositis Diseases 0.000 claims 2
- 201000009594 systemic scleroderma Diseases 0.000 claims 2
- 102100005826 CD19 Human genes 0.000 claims 1
- 101700087100 CD19 Proteins 0.000 claims 1
- 102100000189 CD22 Human genes 0.000 claims 1
- 101700020617 CD22 Proteins 0.000 claims 1
- 102100013137 CD40 Human genes 0.000 claims 1
- 101710040446 CD40 Proteins 0.000 claims 1
- 102100005828 CD5 Human genes 0.000 claims 1
- 101700066525 CD5 Proteins 0.000 claims 1
- 102100005832 CD69 Human genes 0.000 claims 1
- 101700080416 CD69 Proteins 0.000 claims 1
- 102100005830 CD70 Human genes 0.000 claims 1
- 101700017377 CD70 Proteins 0.000 claims 1
- 102100019451 CD80 Human genes 0.000 claims 1
- 101700080477 CD80 Proteins 0.000 claims 1
- 101700020447 CR2 Proteins 0.000 claims 1
- 102100009368 CR2 Human genes 0.000 claims 1
- 101700053597 FCER2 Proteins 0.000 claims 1
- 102100014608 FCER2 Human genes 0.000 claims 1
- 101700082799 IL2RA Proteins 0.000 claims 1
- 101700015336 ISG20 Proteins 0.000 claims 1
- 102100002950 ISG20 Human genes 0.000 claims 1
- 102100004893 LILRA5 Human genes 0.000 claims 1
- 101710002796 LILRA5 Proteins 0.000 claims 1
- 101710002781 LILRB1 Proteins 0.000 claims 1
- 210000000265 Leukocytes Anatomy 0.000 claims 1
- 102100000165 MS4A1 Human genes 0.000 claims 1
- 101710010909 MS4A1 Proteins 0.000 claims 1
- 230000001154 acute Effects 0.000 claims 1
- 230000001363 autoimmune Effects 0.000 claims 1
- 108010052926 complement C3d,g Proteins 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 210000002865 immune cell Anatomy 0.000 claims 1
- 239000003550 marker Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
Claims (10)
- 被検者について、Ｂリンパ球抗原に対する潜在的治療用抗体の結合を評価する方法において、前記被検者からの白血球細胞を含む血液試料について、
前記試料中のＢリンパ球の表面上の少なくとも１つのバイオマーカの存在レベルを定量化する工程であって、前記バイオマーカは、Ｃ４ｄ、Ｃ３ｄ、Ｃ４ｂ、ｉＣ４ｂ、Ｃ３ｂ、ｉＣ３ｂ、及びＣ３ｄｇからなる群から選択される、工程と、
前記被検者の前記バイオマーカの存在レベルを対照試料のＢリンパ球の表面上の前記バイオマーカの存在レベルと比較することで、前記被検者の前記バイオーマーカの存在レベルが前記対照試料における存在レベルに比べて上昇しているか否かを判定する工程と、
前記対照試料における存在レベルと比較した前記被検者からの前記血液試料中の前記バイオマーカの存在レベルの増加を、前記被検者のＢリンパ球上の前記Ｂリンパ球抗原に対する前記潜在的治療用抗体の結合の減少と関連付ける工程と、
を含んでおり、
前記バイオマーカーの存在レベルの増加は、前記潜在的治療用抗体の前記被験者への投与前に、且つ、前記潜在的治療用抗体によって標的化される前記Ｂリンパ球抗原の発現に無関係に検出される、方法。 - 前記バイオマーカはＣ４ｄである、請求項１に記載の方法。
- 前記Ｂリンパ球抗原は、ＣＤ５、ＣＤ１９、ＣＤ２０、ＣＤ２１、ＣＤ２２、ＣＤ２３、ＣＤ２５、ＣＤ４０、ＣＤ６９、ＣＤ７０、ＣＤ７９、ＣＤ８０、ＣＤ８５、ＣＤ８６、ＣＤ１３７、ＣＤ１３８、ＣＤ２５２、及びＣＤ２６８からなる群から選択される、請求項１に記載の方法。
- 前記対照試料が、より早い時期に前記被験者から得られた試料である、請求項１に記載の方法。
- 前記被験者のＢリンパ球上の前記Ｂリンパ球抗原に対する前記潜在的治療用抗体の結合の減少は、前記被験者が前記潜在的治療用抗体による治療に有利に反応する可能性が低いことを同定する、請求項１に記載の方法。
- 前記被検者は、自己免疫疾患又は自己免疫障害を有する疑いがある、或いは、自己免疫疾患又は自己免疫障害について検査されており、前記対照試料は、前記自己免疫疾患又は自己免疫障害を患っていない１又は複数の個体を含む対照セットから得られる、請求項１に記載の方法。
- 前記自己免疫疾患または自己免疫障害は、全身性エリテマトーデス（ＳＬＥ）、関節リウマチ、シェーグレン症候群、全身性硬化症、血管炎、混合型クリオグロブリン血症、及び炎症性ミオパチーからなる群より選択される、請求項６に記載の方法。
- 前記被検者は、自己免疫疾患又は自己免疫障害を有する疑いがある、或いは、自己免疫疾患又は自己免疫障害について検査されており、前記対照試料は、前記自己免疫疾患又は自己免疫障害を有するが、前記自己免疫疾患又は自己免疫障害の急性期を経験していない１又は複数の個体を含む対照セットから得られる、請求項１に記載の方法。
- 前記自己免疫疾患または自己免疫障害は、全身性エリテマトーデス（ＳＬＥ）、関節リウマチ、シェーグレン症候群、全身性硬化症、血管炎、混合型クリオグロブリン血症、及び炎症性ミオパチーからなる群より選択される、請求項８に記載の方法。
- 前記被検者は、Ｂ細胞リンパ腫を有する疑いがある、或いは、Ｂ細胞リンパ腫について検査されており、前記対照試料は、Ｂ細胞リンパ腫を患っていない１又は複数の個体の対照セットから得られる、請求項１に記載の方法。
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 true JP2018528439A5 (ja) | 2019-09-05 |
| JP6674543B2 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 (ja) |
| EP (1) | EP3329278A4 (ja) |
| JP (1) | JP6674543B2 (ja) |
| AU (1) | AU2016303499B2 (ja) |
| CA (1) | CA2990722C (ja) |
| IL (1) | IL256618A (ja) |
| WO (1) | WO2017023781A1 (ja) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102604687B1 (ko) * | 2017-02-01 | 2023-11-20 | 삼성전자주식회사 | 이미지 센서 및 그 제조 방법 |
| US11698367B2 (en) | 2017-09-15 | 2023-07-11 | Beckman Coulter, Inc. | Flow based assays for therapeutics |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK1432731T3 (da) | 2001-09-10 | 2010-11-22 | Univ Pittsburgh | Diagnose og monitering af systemisk lupus erythematosus og af scleroderma |
| JP4550051B2 (ja) | 2003-04-16 | 2010-09-22 | ユニバーシティ オブ ピッツバーグ オブ ザ コモンウェルス システム オブ ハイヤー エデュケイション | 全身性エリテマトーデスの同定およびモニタリング |
| AU2004249155B2 (en) | 2003-06-13 | 2009-11-19 | University Of Pittsburgh - Of The Commonwealth System Of Higher Education | Monitoring immunologic, hematologic and inflammatory diseases |
| AU2005242719B2 (en) * | 2004-05-11 | 2011-02-24 | University Of Pittsburgh - Of The Commonwealth System Of Higher Education | Diagnosing and monitoring inflammatory diseases by measuring complement components on white blood cells |
| EP1904101A4 (en) * | 2005-06-08 | 2011-06-15 | Univ Duke | ANTI-CD19 ANTIBODY THERAPY FOR TRANSPLANTATION |
| EP2347259A4 (en) | 2008-10-16 | 2012-02-29 | Cypress Bioscience Inc | METHOD FOR DIAGNOSIS AND MONITORING OF ILLICIT ACTIVITY AND RESPONSE TO TREATMENT IN SYSTEMIC LUPUS ERYTHEMATODES (SLE) AND OTHER AUTOIMMUNE DISEASES |
| EP2352998A4 (en) | 2008-11-07 | 2011-09-21 | Centocor Ortho Biotech Inc | MARKERS AND METHOD FOR THE STUDY AND TREATMENT OF LIGHT-SENSITIVELY LUPUS PATIENTS |
| 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 |
| EP2791675B1 (en) | 2011-12-13 | 2018-04-25 | Baxalta GmbH | Measurement of autoantibodies in low conductivity conditions |
| 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 |
| RU2019103573A (ru) * | 2013-02-08 | 2019-03-15 | Аллегени-Сингер Рисерч Инститьют | Клеточно-связанные продукты активации комплемента в качестве диагностических биомаркеров волчанки в доклинической стадии |
| 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 |
| WO2016023006A1 (en) | 2014-08-08 | 2016-02-11 | Allegheny-Singer Research Institute | Anti-lymphocyte autoantibodies as diagnostic biomarkers |
-
2016
- 2016-07-29 CA CA2990722A patent/CA2990722C/en active Active
- 2016-07-29 WO PCT/US2016/044779 patent/WO2017023781A1/en unknown
- 2016-07-29 US US15/223,906 patent/US10067128B2/en active Active
- 2016-07-29 AU AU2016303499A patent/AU2016303499B2/en active Active
- 2016-07-29 JP JP2018525527A patent/JP6674543B2/ja active Active
- 2016-07-29 EP EP16833629.5A patent/EP3329278A4/en active Pending
-
2017
- 2017-12-27 IL IL256618A patent/IL256618A/en active IP Right Grant
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