AU2019301614B2 - Methods for mitigating drug target interference in an anti-drug antibody (ADA) immunoassay - Google Patents

Methods for mitigating drug target interference in an anti-drug antibody (ADA) immunoassay

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Publication number
AU2019301614B2
AU2019301614B2 AU2019301614A AU2019301614A AU2019301614B2 AU 2019301614 B2 AU2019301614 B2 AU 2019301614B2 AU 2019301614 A AU2019301614 A AU 2019301614A AU 2019301614 A AU2019301614 A AU 2019301614A AU 2019301614 B2 AU2019301614 B2 AU 2019301614B2
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AU
Australia
Prior art keywords
drug
target
ada
drug target
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
AU2019301614A
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English (en)
Other versions
AU2019301614A1 (en
Inventor
Jihua CHEN
Giane OLIVEIRA SUMNER
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.)
Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Filing date
Publication date
Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of AU2019301614A1 publication Critical patent/AU2019301614A1/en
Application granted granted Critical
Publication of AU2019301614B2 publication Critical patent/AU2019301614B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • G01N33/5306—Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
    • 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
    • G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies
    • 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
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • 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
    • G01N33/94—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Food Science & Technology (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
AU2019301614A 2018-07-10 2019-07-09 Methods for mitigating drug target interference in an anti-drug antibody (ADA) immunoassay Active AU2019301614B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862696016P 2018-07-10 2018-07-10
US62/696,016 2018-07-10
PCT/US2019/040950 WO2020014194A1 (en) 2018-07-10 2019-07-09 Methods for mitigating drug target interference in an anti-drug antibody (ada) immunoassay

Publications (2)

Publication Number Publication Date
AU2019301614A1 AU2019301614A1 (en) 2020-10-22
AU2019301614B2 true AU2019301614B2 (en) 2025-11-20

Family

ID=67544324

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019301614A Active AU2019301614B2 (en) 2018-07-10 2019-07-09 Methods for mitigating drug target interference in an anti-drug antibody (ADA) immunoassay

Country Status (16)

Country Link
US (2) US12055551B2 (enExample)
EP (1) EP3821255B1 (enExample)
JP (3) JP7493459B2 (enExample)
KR (1) KR102754704B1 (enExample)
CN (1) CN112384808B (enExample)
AU (1) AU2019301614B2 (enExample)
BR (1) BR112020022912A2 (enExample)
EA (1) EA202190237A1 (enExample)
ES (1) ES2993989T3 (enExample)
IL (1) IL277888B2 (enExample)
MA (1) MA53130A (enExample)
MX (1) MX2021000331A (enExample)
MY (1) MY207418A (enExample)
SG (1) SG11202011283TA (enExample)
WO (1) WO2020014194A1 (enExample)
ZA (1) ZA202006409B (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2022011336A (es) * 2020-03-17 2022-10-07 Regeneron Pharma Atenuacion de la interferencia de dianas en ensayo de anticuerpos antifarmacos.
CN114264814B (zh) * 2021-12-30 2025-03-14 苏州和锐生物科技有限公司 一种pd-1生物制剂的抗体检测试剂盒及制备方法
CN114324894A (zh) * 2021-12-31 2022-04-12 军科正源（北京）药物研究有限责任公司 一种检测贝伐珠单抗抗药性抗体的新型分析方法
CN114047343B (zh) * 2022-01-13 2022-05-31 美迪西普亚医药科技(上海)有限公司 双耐受型抗IgE单抗药物的免疫原性分析试剂盒及其使用方法和应用
WO2023204378A1 (ko) * 2022-04-19 2023-10-26 의료법인 성광의료재단 혈액 내 항-약물항체 농도 측정을 통한 생물학적 약물에 대한 치료 반응성 예측 방법
AU2023329315A1 (en) * 2022-08-24 2025-01-16 Amgen Inc. Anti-drug antibody assays
CN115586337A (zh) * 2022-09-14 2023-01-10 杭州赛基生物科技有限公司 检测肿瘤伴随诊断相关因子的试剂盒及其制备方法
US20250383363A1 (en) * 2022-09-23 2025-12-18 Merck Sharp & Dohme Llc Neutralization antibody assay method
CN115575468B (zh) * 2022-09-30 2025-08-26 华润生物医药有限公司 一种检测抗重组人GLP-1-Fc融合蛋白抗体的方法
CN115856322A (zh) * 2022-12-23 2023-03-28 同昕生物技术（北京）有限公司 用于抗奥马株单抗药物抗体检测的试剂及其应用
CN117805382B (zh) * 2024-02-28 2024-05-03 军科正源（北京）药物研究有限责任公司 检测抗利妥昔单抗中和抗体的方法
WO2025224166A1 (en) * 2024-04-23 2025-10-30 F. Hoffmann-La Roche Ag Anti-drug antibody assays

Citations (1)

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Publication number Priority date Publication date Assignee Title
US20150226758A1 (en) * 2014-02-11 2015-08-13 Genzyme Corporation Assays for detecting the presence or amount of an anti-drug antibody

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US3856469A (en) 1973-01-02 1974-12-24 Syva Corp Interferant removal from amphetamine immunoassay
JPS55145690A (en) 1979-05-04 1980-11-13 Toyama Chem Co Ltd Novel penicillin and cephalosporin, and its salt
JPS6454356A (en) * 1987-08-26 1989-03-01 Meidensha Electric Mfg Co Ltd Method for suppressing non-specific adsorption of antibody to solid phase antigen
JPH02138872A (ja) * 1988-11-18 1990-05-28 Asahi Chem Ind Co Ltd 癌関連物質のための免疫測定方法
JPWO2005031353A1 (ja) 2003-09-26 2006-12-07 松下電器産業株式会社 免疫反応測定方法、ならびにそれに用いる試薬、キット、及び光学セル
CA2686206A1 (en) * 2007-05-07 2008-11-13 Wyeth Elimination of interference in immunoassays caused by anti-carbohydrate antibodies
WO2009022001A1 (en) 2007-08-16 2009-02-19 Novartis Ag Improvement of drug tolerance in immunogenicity testing
SG10201805064SA (en) 2011-06-23 2018-07-30 Ablynx Nv Techniques for predicting, detecting and reducing aspecific protein interference in assays involving immunoglobulin single variable domains
BR112015032960B1 (pt) * 2013-07-04 2021-01-05 F. Hoffmann-La Roche Ag imunoensaio suprimido por interferência para detectar anticorpos anti-fármaco em amostras de soro
WO2017096262A1 (en) * 2015-12-04 2017-06-08 Jomoco, Corp. Compositions and methods to mitigate or prevent an immune response to an immunogenic therapeutic molecule in non-human primates
US20190145985A1 (en) 2017-11-10 2019-05-16 BioAgilytix Labs, LLC Method for eliminating target interference
MX2020004921A (es) 2017-11-29 2020-08-27 Hoffmann La Roche Ensayo de anticuerpo antifarmaco con supresion de interferencia del objetivo.
MX2022011336A (es) * 2020-03-17 2022-10-07 Regeneron Pharma Atenuacion de la interferencia de dianas en ensayo de anticuerpos antifarmacos.

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150226758A1 (en) * 2014-02-11 2015-08-13 Genzyme Corporation Assays for detecting the presence or amount of an anti-drug antibody

Non-Patent Citations (2)

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DAI S. ET AL.: "Development of a method that eliminates false-positive results due to nerve growth factor interference in the assessment of fulranumab immunogenicity", AAPS J., vol. 16, no. 3, May 2014, pages 464 - 477, XP035314386 *
LIAO K. ET AL.: "Inhibition of interleukin-5 induced false positive anti-drug antibody responses against mepolizumab through the use of a competitive blocking antibody", J. IMMUNOL. METH., vol. 441, 2016, pages 15 - 23, XP029894802 *

Also Published As

Publication number Publication date
CN112384808B (zh) 2024-10-11
AU2019301614A1 (en) 2020-10-22
KR102754704B1 (ko) 2025-01-20
ZA202006409B (en) 2025-07-30
WO2020014194A1 (en) 2020-01-16
MX2021000331A (es) 2021-03-25
JP7493459B2 (ja) 2024-05-31
EP3821255A1 (en) 2021-05-19
US20200018770A1 (en) 2020-01-16
BR112020022912A2 (pt) 2021-02-23
US12055551B2 (en) 2024-08-06
IL277888A (en) 2020-11-30
KR20210031854A (ko) 2021-03-23
CA3098206A1 (en) 2020-01-16
JP2021531448A (ja) 2021-11-18
US20240353423A1 (en) 2024-10-24
SG11202011283TA (en) 2020-12-30
CN112384808A (zh) 2021-02-19
IL277888B1 (en) 2024-12-01
ES2993989T3 (en) 2025-01-15
EA202190237A1 (ru) 2021-04-15
JP2026012856A (ja) 2026-01-27
EP3821255B1 (en) 2024-08-28
MY207418A (en) 2025-02-26
IL277888B2 (en) 2025-04-01
JP2024045646A (ja) 2024-04-02
MA53130A (fr) 2021-05-19

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