CA2990722C - Cell-bound complement activation product assays as companion diagnostics for antibody-based drugs - Google Patents

Cell-bound complement activation product assays as companion diagnostics for antibody-based drugs Download PDF

Info

Publication number
CA2990722C
CA2990722C CA2990722A CA2990722A CA2990722C CA 2990722 C CA2990722 C CA 2990722C CA 2990722 A CA2990722 A CA 2990722A CA 2990722 A CA2990722 A CA 2990722A CA 2990722 C CA2990722 C CA 2990722C
Authority
CA
Canada
Prior art keywords
subject
level
biomarker
cell
antibody
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
CA2990722A
Other languages
English (en)
French (fr)
Other versions
CA2990722A1 (en
Inventor
Joseph M. Ahearn
Chau-Ching Liu
Susan M. Manzi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Allegheny Singer Research Institute
Original Assignee
Allegheny Singer Research Institute
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 Allegheny Singer Research Institute filed Critical Allegheny Singer Research Institute
Publication of CA2990722A1 publication Critical patent/CA2990722A1/en
Application granted granted Critical
Publication of CA2990722C publication Critical patent/CA2990722C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/564Immunoassay; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008Chemical 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
    • G01N33/5044Chemical 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
    • G01N33/5047Cells of the immune system
    • G01N33/5052Cells of the immune system involving B-cells
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/86Chemical 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
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20ICT 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
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16ZINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
    • G16Z99/00Subject matter not provided for in other main groups of this subclass
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701Details
    • G01N2333/4716Complement proteins, e.g. anaphylatoxin, C3a, C5a
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/52Predicting 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)
CA2990722A 2015-07-31 2016-07-29 Cell-bound complement activation product assays as companion diagnostics for antibody-based drugs Active CA2990722C (en)

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 (2)

Publication Number Publication Date
CA2990722A1 CA2990722A1 (en) 2017-02-09
CA2990722C true CA2990722C (en) 2022-07-05

Family

ID=57885963

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2990722A Active CA2990722C (en) 2015-07-31 2016-07-29 Cell-bound complement activation product assays as companion diagnostics for antibody-based drugs

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
JP6674543B2 (ja) 2020-04-01
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
Yang et al. Mass cytometry analysis reveals that specific intratumoral CD4+ T cell subsets correlate with patient survival in follicular lymphoma
Moradi et al. CD4+ CD25+/highCD127low/-regulatory T cells are enriched in rheumatoid arthritis and osteoarthritis joints—analysis of frequency and phenotype in synovial membrane, synovial fluid and peripheral blood
Pandya et al. Blood chemokine profile in untreated early rheumatoid arthritis: CXCL10 as a disease activity marker
Van Baarsen et al. The cellular composition of lymph nodes in the earliest phase of inflammatory arthritis
Koch et al. Multiparameter flow cytometric analysis of CD4 and CD8 T cell subsets in young and old people
Sellam et al. Blood memory B cells are disturbed and predict the response to rituximab in patients with rheumatoid arthritis
Yam-Puc et al. Age-associated B cells predict impaired humoral immunity after COVID-19 vaccination in patients receiving immune checkpoint blockade
Obry et al. Identification of S100A9 as biomarker of responsiveness to the methotrexate/etanercept combination in rheumatoid arthritis using a proteomic approach
Morel et al. Flow cytometric analysis reveals the high levels of platelet activation parameters in circulation of multiple sclerosis patients
Fedele et al. Memory B cell subsets and plasmablasts are lower in early than in long-standing rheumatoid arthritis
Soh et al. Methodological considerations for the high sensitivity detection of multiple myeloma measurable residual disease
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
Stradner et al. A combination of cellular biomarkers predicts failure to respond to rituximab in rheumatoid arthritis: a 24-week observational study
Untch et al. Prevalence, isotype, and functionality of antiheparin–platelet factor 4 antibodies in patients treated with heparin and clinically suspected for heparin-induced thrombocytopenia: The pathogenic role of IgG
WO2017194779A1 (en) Use of anti-cd26 antibody levels as autoimmune and/or inflammatory disease biomarkers
Luo et al. Decreased expression of TIGIT in NK cells correlates negatively with disease activity in systemic lupus erythematosus
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
Micsik et al. MDR-1 and MRP-1 activity in peripheral blood leukocytes of rheumatoid arthritis patients
US10067128B2 (en) Cell-bound complement activation product assays as companion diagnostics for antibody-based drugs
Kim et al. Detection of anti‐aquaporin‐4 antibodies in neuromyelitis optica: comparison of tissue‐based and cell‐based indirect immunofluorescence assays and ELISA
Dezorella et al. Measurement of lymphocyte aggregation by flow cytometry–physiological implications in chronic lymphocytic leukemia
Dorfman et al. FLOCK cluster analysis of plasma cell flow cytometry data predicts bone marrow involvement by plasma cell neoplasia
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

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20210723

MPN Maintenance fee for patent paid

Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 8TH ANNIV.) - STANDARD

Year of fee payment: 8

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20240719

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20240719

MPN Maintenance fee for patent paid

Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 9TH ANNIV.) - STANDARD

Year of fee payment: 9

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250725

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250725