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CO2019009034A2 - Formulación de anticuerpo monoclonal anti-vrs referencia cruzada a solicitudes relacionadas - Google Patents

Formulación de anticuerpo monoclonal anti-vrs referencia cruzada a solicitudes relacionadas

Info

Publication number
CO2019009034A2
CO2019009034A2 CONC2019/0009034A CO2019009034A CO2019009034A2 CO 2019009034 A2 CO2019009034 A2 CO 2019009034A2 CO 2019009034 A CO2019009034 A CO 2019009034A CO 2019009034 A2 CO2019009034 A2 CO 2019009034A2
Authority
CO
Colombia
Prior art keywords
monoclonal antibody
vrs
antibody formulation
related requests
formulation cross
Prior art date
Application number
CONC2019/0009034A
Other languages
English (en)
Inventor
Brian Lobo
Deborah Goldberg
Original Assignee
Medimmune Ltd
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 Medimmune Ltd filed Critical Medimmune Ltd
Publication of CO2019009034A2 publication Critical patent/CO2019009034A2/es

Links

Classifications

    • 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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Communicable Diseases (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

La presente invención proporciona una formulación que comprende: (i) un anticuerpo monoclonal anti-VRS; y (ii) un excipiente iónico; en donde el anticuerpo monoclonal está presente a una concentración de aproximadamente 50 mg/ml o más y el excipiente iónico está presente a una concentración de entre 50 y 150 mM y la formulación tiene un pH de aproximadamente 5.5 a aproximadamente 7.5.
CONC2019/0009034A 2017-03-01 2019-08-21 Formulación de anticuerpo monoclonal anti-vrs referencia cruzada a solicitudes relacionadas CO2019009034A2 (es)

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
CO2019009034A2 true CO2019009034A2 (es) 2019-08-30

Family

ID=61903153

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2019/0009034A CO2019009034A2 (es) 2017-03-01 2019-08-21 Formulación de anticuerpo monoclonal anti-vrs referencia cruzada a solicitudes relacionadas

Country Status (24)

Country Link
US (4) US10774133B2 (es)
EP (1) EP3589648A4 (es)
JP (2) JP7046088B2 (es)
KR (2) KR102668158B1 (es)
CN (3) CN116059343A (es)
AR (1) AR111083A1 (es)
AU (2) AU2018227502B2 (es)
BR (1) BR112019017755A2 (es)
CA (1) CA3051864A1 (es)
CL (1) CL2019002478A1 (es)
CO (1) CO2019009034A2 (es)
CR (1) CR20190400A (es)
EA (1) EA201991701A1 (es)
EC (1) ECSP19062769A (es)
GB (1) GB2564175B (es)
IL (2) IL312499A (es)
MX (1) MX2019010408A (es)
MY (1) MY206022A (es)
PH (1) PH12019501979A1 (es)
SG (1) SG11201906853QA (es)
TW (2) TWI761453B (es)
UA (1) UA128450C2 (es)
WO (1) WO2018160722A1 (es)
ZA (1) ZA202006797B (es)

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MX2019013072A (es) 2017-05-02 2019-12-16 Merck Sharp & Dohme Formulaciones de anticuerpos anti-lag3 y coformulaciones de anticuerpos anti-lag3 y anticuerpos anti-pd-1.
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EP3876990A4 (en) 2018-11-07 2023-09-06 Merck Sharp & Dohme LLC CO-FORMULATIONS OF ANTI-LAG3 ANTIBODIES AND ANTI-PD-1 ANTIBODIES
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UY39135A (es) 2020-03-26 2021-10-29 Univ Vanderbilt ANTICUERPOS MONOCLONALES HUMANOS DIRIGIDOS CONTRAEL CORONAVIRUS 2 DEL SÍNDROME RESPIRATORIO AGUDO GRAVE (SARS-CoV-2)
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EP3589318A1 (en) * 2017-03-01 2020-01-08 MedImmune Limited Formulations of monoclonal antibodies
US12024553B2 (en) * 2019-04-30 2024-07-02 Medimmune Limited Dosage regimens for and compositions including anti-RSV antibodies

Also Published As

Publication number Publication date
BR112019017755A2 (pt) 2020-04-07
GB201802974D0 (en) 2018-04-11
GB2564175B (en) 2021-12-08
AR111083A1 (es) 2019-05-29
IL312499A (en) 2024-07-01
US20180251526A1 (en) 2018-09-06
TW202228779A (zh) 2022-08-01
WO2018160722A1 (en) 2018-09-07
SG11201906853QA (en) 2019-09-27
ZA202006797B (en) 2023-03-29
GB2564175A (en) 2019-01-09
EP3589648A4 (en) 2020-12-23
KR20190125318A (ko) 2019-11-06
MY206022A (en) 2024-11-25
MX2019010408A (es) 2019-12-19
IL268202A (en) 2019-09-26
PH12019501979A1 (en) 2020-06-29
US20200339667A1 (en) 2020-10-29
JP7046088B2 (ja) 2022-04-01
AU2018227502A1 (en) 2019-08-15
CA3051864A1 (en) 2018-09-07
US11667698B2 (en) 2023-06-06
KR102359181B1 (ko) 2022-02-08
AU2022263564B2 (en) 2025-05-22
EP3589648A1 (en) 2020-01-08
UA128450C2 (uk) 2024-07-17
TW201840334A (zh) 2018-11-16
JP7446356B2 (ja) 2024-03-08
US20210317191A1 (en) 2021-10-14
ECSP19062769A (es) 2019-09-30
CN110418803B (zh) 2024-01-19
US10774133B2 (en) 2020-09-15
US20230399383A1 (en) 2023-12-14
AU2018227502B2 (en) 2022-08-11
US11286294B2 (en) 2022-03-29
AU2022263564A1 (en) 2022-12-15
KR20220020420A (ko) 2022-02-18
NZ755790A (en) 2024-04-26
CR20190400A (es) 2019-12-03
IL268202B2 (en) 2024-10-01
CN117982637A (zh) 2024-05-07
TWI761453B (zh) 2022-04-21
IL268202B1 (en) 2024-06-01
CN110418803A (zh) 2019-11-05
KR102668158B1 (ko) 2024-05-23
EA201991701A1 (ru) 2020-03-04
CN116059343A (zh) 2023-05-05
JP2020509031A (ja) 2020-03-26
CL2019002478A1 (es) 2020-01-24
JP2022095697A (ja) 2022-06-28

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