AU2018227502B2 - Anti-RSV monoclonal antibody formulation - Google Patents

Anti-RSV monoclonal antibody formulation Download PDF

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Publication number
AU2018227502B2
AU2018227502B2 AU2018227502A AU2018227502A AU2018227502B2 AU 2018227502 B2 AU2018227502 B2 AU 2018227502B2 AU 2018227502 A AU2018227502 A AU 2018227502A AU 2018227502 A AU2018227502 A AU 2018227502A AU 2018227502 B2 AU2018227502 B2 AU 2018227502B2
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AU
Australia
Prior art keywords
formulation
concentration
sequence
monoclonal antibody
seq
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Application number
AU2018227502A
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English (en)
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AU2018227502A1 (en
Inventor
Deborah GOLDBERG
Brian Lobo
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MedImmune Ltd
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MedImmune Ltd
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Publication of AU2018227502A1 publication Critical patent/AU2018227502A1/en
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Priority to AU2022263564A priority Critical patent/AU2022263564B2/en
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    • 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—RNA viruses
    • C07K16/102—Coronaviridae (F)
    • C07K16/104—Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—RNA viruses
    • C07K16/11—Paramyxoviridae (F); Pneumoviridae (F), e.g. respiratory syncytial virus [RSV]
    • 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)
  • General Health & Medical Sciences (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pulmonology (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)
AU2018227502A 2017-03-01 2018-02-28 Anti-RSV monoclonal antibody formulation Active 2038-11-24 AU2018227502B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2022263564A AU2022263564B2 (en) 2017-03-01 2022-11-04 Anti-rsv monoclonal antibody formulation

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762465379P 2017-03-01 2017-03-01
US62/465,379 2017-03-01
PCT/US2018/020264 WO2018160722A1 (en) 2017-03-01 2018-02-28 Anti-rsv monoclonal antibody formulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2022263564A Division AU2022263564B2 (en) 2017-03-01 2022-11-04 Anti-rsv monoclonal antibody formulation

Publications (2)

Publication Number Publication Date
AU2018227502A1 AU2018227502A1 (en) 2019-08-15
AU2018227502B2 true AU2018227502B2 (en) 2022-08-11

Family

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AU2018227502A Active 2038-11-24 AU2018227502B2 (en) 2017-03-01 2018-02-28 Anti-RSV monoclonal antibody formulation
AU2022263564A Active AU2022263564B2 (en) 2017-03-01 2022-11-04 Anti-rsv monoclonal antibody formulation

Family Applications After (1)

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AU2022263564A Active AU2022263564B2 (en) 2017-03-01 2022-11-04 Anti-rsv monoclonal antibody formulation

Country Status (24)

Country Link
US (4) US10774133B2 (https=)
EP (1) EP3589648A4 (https=)
JP (2) JP7046088B2 (https=)
KR (2) KR102668158B1 (https=)
CN (3) CN116059343A (https=)
AR (1) AR111083A1 (https=)
AU (2) AU2018227502B2 (https=)
BR (1) BR112019017755A2 (https=)
CA (1) CA3051864A1 (https=)
CL (1) CL2019002478A1 (https=)
CO (1) CO2019009034A2 (https=)
CR (1) CR20190400A (https=)
EA (1) EA201991701A1 (https=)
EC (1) ECSP19062769A (https=)
GB (1) GB2564175B (https=)
IL (2) IL268202B2 (https=)
MX (1) MX2019010408A (https=)
MY (1) MY206022A (https=)
PH (1) PH12019501979A1 (https=)
SG (1) SG11201906853QA (https=)
TW (2) TWI761453B (https=)
UA (1) UA128450C2 (https=)
WO (1) WO2018160722A1 (https=)
ZA (1) ZA202006797B (https=)

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BR112019018022A2 (pt) * 2017-03-01 2020-06-02 Medimmune Limited Formulações de anticorpos monoclonais
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
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
AU2018263868A1 (en) 2017-05-02 2019-12-12 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies
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CN120842406A (zh) 2018-10-31 2025-10-28 默沙东有限责任公司 抗人pd-1抗体晶体及其使用方法
CN113316458B (zh) 2018-11-07 2024-08-02 默沙东有限责任公司 抗lag3抗体和抗pd-1抗体的共制剂
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TW202342510A (zh) 2022-02-18 2023-11-01 英商Ｒｑ生物科技有限公司 抗體
CN119264248A (zh) * 2022-07-22 2025-01-07 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
WO2024120516A1 (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

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Also Published As

Publication number Publication date
CO2019009034A2 (es) 2019-08-30
EP3589648A4 (en) 2020-12-23
EA201991701A1 (ru) 2020-03-04
KR20220020420A (ko) 2022-02-18
US11286294B2 (en) 2022-03-29
AU2018227502A1 (en) 2019-08-15
JP7446356B2 (ja) 2024-03-08
AU2022263564B2 (en) 2025-05-22
JP2020509031A (ja) 2020-03-26
IL312499A (en) 2024-07-01
IL268202B2 (en) 2024-10-01
AU2022263564A1 (en) 2022-12-15
US20230399383A1 (en) 2023-12-14
IL268202B1 (en) 2024-06-01
GB201802974D0 (en) 2018-04-11
SG11201906853QA (en) 2019-09-27
CL2019002478A1 (es) 2020-01-24
CR20190400A (es) 2019-12-03
KR102359181B1 (ko) 2022-02-08
US10774133B2 (en) 2020-09-15
BR112019017755A2 (pt) 2020-04-07
EP3589648A1 (en) 2020-01-08
AR111083A1 (es) 2019-05-29
JP2022095697A (ja) 2022-06-28
UA128450C2 (uk) 2024-07-17
ECSP19062769A (es) 2019-09-30
KR102668158B1 (ko) 2024-05-23
US20210317191A1 (en) 2021-10-14
MX2019010408A (es) 2019-12-19
GB2564175B (en) 2021-12-08
ZA202006797B (en) 2023-03-29
TW202228779A (zh) 2022-08-01
TWI911431B (zh) 2026-01-11
US11667698B2 (en) 2023-06-06
US20200339667A1 (en) 2020-10-29
IL268202A (en) 2019-09-26
TWI761453B (zh) 2022-04-21
CA3051864A1 (en) 2018-09-07
TW201840334A (zh) 2018-11-16
MY206022A (en) 2024-11-25
PH12019501979A1 (en) 2020-06-29
WO2018160722A1 (en) 2018-09-07
CN110418803B (zh) 2024-01-19
CN110418803A (zh) 2019-11-05
JP7046088B2 (ja) 2022-04-01
NZ755790A (en) 2024-04-26
CN116059343A (zh) 2023-05-05
KR20190125318A (ko) 2019-11-06
US20180251526A1 (en) 2018-09-06
CN117982637A (zh) 2024-05-07
GB2564175A (en) 2019-01-09

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