EA201991701A1 - Состав на основе моноклонального антитела к rsv - Google Patents

Состав на основе моноклонального антитела к rsv

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Publication number
EA201991701A1
EA201991701A1 EA201991701A EA201991701A EA201991701A1 EA 201991701 A1 EA201991701 A1 EA 201991701A1 EA 201991701 A EA201991701 A EA 201991701A EA 201991701 A EA201991701 A EA 201991701A EA 201991701 A1 EA201991701 A1 EA 201991701A1
Authority
EA
Eurasian Patent Office
Prior art keywords
monoclonal antibody
rsv
composition based
present
concentration
Prior art date
Application number
EA201991701A
Other languages
English (en)
Inventor
Брайн Лобо
Дебора Голдберг
Original Assignee
Медиммун Лимитед
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 Медиммун Лимитед filed Critical Медиммун Лимитед
Publication of EA201991701A1 publication Critical patent/EA201991701A1/ru

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/42—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1002—Coronaviridae
    • C07K16/1003—Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2 or Covid-19]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1027—Paramyxoviridae, e.g. respiratory syncytial virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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
    • C07K2317/522—CH1 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Virology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Настоящее изобретение предусматривает состав, содержащий (i) моноклональное антитело к RSV и (ii) ионное вспомогательное вещество; где моноклональное антитело присутствует в концентрации, составляющей приблизительно 50 мг/мл или больше, ионное вспомогательное вещество присутствует в концентрации от 50 до 150 мМ и состав характеризуется рН, составляющим от приблизительно 5,5 до приблизительно 7,5.
EA201991701A 2017-03-01 2018-02-28 Состав на основе моноклонального антитела к rsv EA201991701A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762465379P 2017-03-01 2017-03-01
PCT/US2018/020264 WO2018160722A1 (en) 2017-03-01 2018-02-28 Anti-rsv monoclonal antibody formulation

Publications (1)

Publication Number Publication Date
EA201991701A1 true EA201991701A1 (ru) 2020-03-04

Family

ID=61903153

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201991701A EA201991701A1 (ru) 2017-03-01 2018-02-28 Состав на основе моноклонального антитела к rsv

Country Status (22)

Country Link
US (4) US10774133B2 (ru)
EP (1) EP3589648A4 (ru)
JP (2) JP7046088B2 (ru)
KR (2) KR102668158B1 (ru)
CN (3) CN116059343A (ru)
AR (1) AR111083A1 (ru)
AU (2) AU2018227502B2 (ru)
BR (1) BR112019017755A2 (ru)
CA (1) CA3051864A1 (ru)
CL (1) CL2019002478A1 (ru)
CO (1) CO2019009034A2 (ru)
CR (1) CR20190400A (ru)
EA (1) EA201991701A1 (ru)
EC (1) ECSP19062769A (ru)
GB (1) GB2564175B (ru)
IL (1) IL268202B1 (ru)
MX (1) MX2019010408A (ru)
PH (1) PH12019501979A1 (ru)
SG (1) SG11201906853QA (ru)
TW (2) TWI761453B (ru)
WO (1) WO2018160722A1 (ru)
ZA (1) ZA202006797B (ru)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4353316A2 (en) 2014-01-15 2024-04-17 Medimmune Limited Rsv-specific antibodies and functional parts thereof
TWI761453B (zh) 2017-03-01 2022-04-21 英商梅迪繆思有限公司 抗rsv單株抗體配製物
WO2018158332A1 (en) * 2017-03-01 2018-09-07 Medimmune Limited Formulations of monoclonal antibodies
RU2019138507A (ru) 2017-05-02 2021-06-02 Мерк Шарп И Доум Корп. Составы антител против lag3 и совместные составы антител против lag3 и антител против pd-1
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
MX2021004356A (es) 2018-10-18 2021-05-31 Merck Sharp & Dohme Llc Formulaciones de anticuerpos anti-rsv y metodos de uso de las mismas.
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
US20220195016A1 (en) * 2019-04-18 2022-06-23 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Biological and synthetic molecules inhibiting respiratory syncytial virus infection
US20200347120A1 (en) 2019-04-30 2020-11-05 Medimmune Limited Dosage regimens for and compositions including anti-rsv antibodies
CN115960214A (zh) * 2021-10-12 2023-04-14 中国科学院分子细胞科学卓越创新中心 中和呼吸道合胞病毒的全人抗体的设计及应用
CN116987183A (zh) * 2022-07-22 2023-11-03 北京智仁美博生物科技有限公司 抗呼吸道合胞病毒中和性抗体及其用途
WO2024120517A1 (zh) * 2022-12-08 2024-06-13 南京诺唯赞生物科技股份有限公司 特异性结合rsv的抗体

Family Cites Families (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5892019A (en) 1987-07-15 1999-04-06 The United States Of America, As Represented By The Department Of Health And Human Services Production of a single-gene-encoded immunoglobulin
US5811524A (en) 1995-06-07 1998-09-22 Idec Pharmaceuticals Corporation Neutralizing high affinity human monoclonal antibodies specific to RSV F-protein and methods for their manufacture and therapeutic use thereof
AU7240096A (en) 1995-09-18 1997-04-09 Government Of The United States Of America, As Represented By The Secretary Of The Department Of Health And Human Services, The Neutralizing monoclonal antibodies to respiratory syncytial virus
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
EP1441589B1 (en) * 2001-11-08 2012-05-09 Abbott Biotherapeutics Corp. Stable liquid pharmaceutical formulation of igg antibodies
US7132100B2 (en) * 2002-06-14 2006-11-07 Medimmune, Inc. Stabilized liquid anti-RSV antibody formulations
AU2013201261B2 (en) * 2002-06-14 2016-06-23 Medimmune, Llc Stabilized liquid anti-RSV antibody formulations
US7425618B2 (en) * 2002-06-14 2008-09-16 Medimmune, Inc. Stabilized anti-respiratory syncytial virus (RSV) antibody formulations
ZA200507757B (en) * 2003-04-04 2007-01-31 Genentech Inc High concentration antibody and protein formulations
TW200636064A (en) 2004-10-28 2006-10-16 Centocor Inc Anti-respiratory syncytial virus antibodies, antigens and uses thereof
WO2007103470A2 (en) * 2006-03-06 2007-09-13 Medimmune, Inc. Humanized anti-cd22 antibodies and their use in treatment of oncology, transplantation and autoimmune disease
EP1997830A1 (en) 2007-06-01 2008-12-03 AIMM Therapeutics B.V. RSV specific binding molecules and means for producing them
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
KR20110063863A (ko) 2008-11-05 2011-06-14 머크 샤프 앤드 돔 코포레이션 생 약독화 호흡기 세포융합 바이러스
WO2011017070A1 (en) * 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
AU2009353693B2 (en) * 2009-10-06 2016-07-21 Medimmune Ltd RSV-specific binding molecule
US8568726B2 (en) 2009-10-06 2013-10-29 Medimmune Limited RSV specific binding molecule
CL2011003002A1 (es) 2011-11-25 2012-05-25 Univ Pontificia Catolica Chile Anticuerpo monoclonal o un fragmento del mismo que se une a la proteina m2-1 del virus respiratorio sincicial (vrs) humano; secuencias nucleotidicas; composicion farmaceutica; metodo de diagnostico de infeccion producida por vrs; kit; y uso de dicho anticuerpo para preparar un medicamento.
BR122019026701B1 (pt) * 2012-03-26 2023-01-24 Sanofi Formulações de agentes de ligação à base de igg4 estáveis, kit, e dispositivo ou recipiente pré-cheios
US20140004131A1 (en) 2012-05-04 2014-01-02 Novartis Ag Antibody formulation
US8883979B2 (en) * 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
JP6450688B2 (ja) 2013-02-01 2019-01-09 メディミューン，エルエルシー 呼吸器合胞体ウイルスｆタンパク質エピトープ
EP4353316A2 (en) * 2014-01-15 2024-04-17 Medimmune Limited Rsv-specific antibodies and functional parts thereof
EP3207061A1 (en) * 2014-10-18 2017-08-23 Pfizer Inc Anti-il-7r antibody compositions
PL3319633T3 (pl) 2015-07-07 2021-04-19 Janssen Vaccines & Prevention B.V. Szczepionka przeciwko rsv
JO3555B1 (ar) 2015-10-29 2020-07-05 Merck Sharp & Dohme جسم مضاد يبطل فعالية فيروس الالتهاب الرئوي البشري
TWI761453B (zh) * 2017-03-01 2022-04-21 英商梅迪繆思有限公司 抗rsv單株抗體配製物
WO2018158332A1 (en) * 2017-03-01 2018-09-07 Medimmune Limited Formulations of monoclonal antibodies

Also Published As

Publication number Publication date
US10774133B2 (en) 2020-09-15
AU2022263564A1 (en) 2022-12-15
GB201802974D0 (en) 2018-04-11
EP3589648A1 (en) 2020-01-08
US20200339667A1 (en) 2020-10-29
KR102668158B1 (ko) 2024-05-23
CA3051864A1 (en) 2018-09-07
US11286294B2 (en) 2022-03-29
JP2020509031A (ja) 2020-03-26
AU2018227502A1 (en) 2019-08-15
GB2564175B (en) 2021-12-08
PH12019501979A1 (en) 2020-06-29
KR20190125318A (ko) 2019-11-06
IL268202A (en) 2019-09-26
CO2019009034A2 (es) 2019-08-30
JP7046088B2 (ja) 2022-04-01
CN110418803A (zh) 2019-11-05
TW201840334A (zh) 2018-11-16
BR112019017755A2 (pt) 2020-04-07
AU2018227502B2 (en) 2022-08-11
EP3589648A4 (en) 2020-12-23
WO2018160722A1 (en) 2018-09-07
US20230399383A1 (en) 2023-12-14
CN116059343A (zh) 2023-05-05
TWI761453B (zh) 2022-04-21
SG11201906853QA (en) 2019-09-27
KR102359181B1 (ko) 2022-02-08
ECSP19062769A (es) 2019-09-30
JP7446356B2 (ja) 2024-03-08
CL2019002478A1 (es) 2020-01-24
KR20220020420A (ko) 2022-02-18
JP2022095697A (ja) 2022-06-28
CR20190400A (es) 2019-12-03
MX2019010408A (es) 2019-12-19
US20180251526A1 (en) 2018-09-06
US20210317191A1 (en) 2021-10-14
US11667698B2 (en) 2023-06-06
ZA202006797B (en) 2023-03-29
CN117982637A (zh) 2024-05-07
GB2564175A (en) 2019-01-09
TW202228779A (zh) 2022-08-01
AR111083A1 (es) 2019-05-29
CN110418803B (zh) 2024-01-19
IL268202B1 (en) 2024-06-01

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