CA3051864A1 - Anti-rsv monoclonal antibody formulation - Google Patents

Anti-rsv monoclonal antibody formulation Download PDF

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Publication number
CA3051864A1
CA3051864A1 CA3051864A CA3051864A CA3051864A1 CA 3051864 A1 CA3051864 A1 CA 3051864A1 CA 3051864 A CA3051864 A CA 3051864A CA 3051864 A CA3051864 A CA 3051864A CA 3051864 A1 CA3051864 A1 CA 3051864A1
Authority
CA
Canada
Prior art keywords
formulation
monoclonal antibody
formulation according
concentration
present
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.)
Pending
Application number
CA3051864A
Other languages
English (en)
French (fr)
Inventor
Brian Lobo
Deborah GOLDBERG
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.)
MedImmune Ltd
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 CA3051864A1 publication Critical patent/CA3051864A1/en
Pending legal-status Critical Current

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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 [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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (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)
CA3051864A 2017-03-01 2018-02-28 Anti-rsv monoclonal antibody formulation Pending CA3051864A1 (en)

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

Publications (1)

Publication Number Publication Date
CA3051864A1 true CA3051864A1 (en) 2018-09-07

Family

ID=61903153

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3051864A Pending CA3051864A1 (en) 2017-03-01 2018-02-28 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) CN117982637A (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) IL312499A (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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EP3383435A4 (en) * 2015-11-30 2019-07-10 Medimmune, LLC OPTIMIZED RATES OF AMINO ACIDS AND SUGARS AS AMORPHOUS STABILIZING COMPOUNDS IN PHARMACEUTICAL COMPOSITIONS HAVING HIGH CONCENTRATIONS IN PROTEIN-BASED THERAPEUTICS
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
BR112019018022A2 (pt) * 2017-03-01 2020-06-02 Medimmune Limited Formulações de anticorpos monoclonais
JP7382232B2 (ja) 2017-05-02 2023-11-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体の製剤および抗ｌａｇ３抗体と抗ｐｄ－１抗体との共製剤
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
WO2020081408A1 (en) 2018-10-18 2020-04-23 Merck Sharp & Dohme Corp. Formulations of anti-rsv antibodies and methods of use thereof
MX2021004928A (es) 2018-10-31 2021-06-08 Merck Sharp & Dohme Llc Cristales de anticuerpo anti-pd-1 humano y metodos de uso de los mismos.
EP3876990A4 (en) 2018-11-07 2023-09-06 Merck Sharp & Dohme LLC CO-FORMULATIONS OF ANTI-LAG3 ANTIBODIES AND ANTI-PD-1 ANTIBODIES
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
CN113993884A (zh) * 2019-04-18 2022-01-28 弗劳恩霍夫应用研究促进协会 抑制呼吸道合胞病毒感染的生物及合成分子
US12024553B2 (en) * 2019-04-30 2024-07-02 Medimmune Limited Dosage regimens for and compositions including anti-RSV antibodies
HRP20240182T1 (hr) 2020-03-26 2024-04-26 Vanderbilt University Ljudska monoklonska protutijela za teški akutni respiratorni sindrom koronavirusa 2 (sars-cov-2)
JP2023537316A (ja) * 2020-07-31 2023-08-31 アラマブ セラピューティクス， インコーポレイテッド 抗コネキシン抗体製剤
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
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
EP4588936A1 (en) * 2022-12-08 2025-07-23 Changchun Bcht Biotechnology Co. Antibodies specifically binding to rsv

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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
BR112019018022A2 (pt) * 2017-03-01 2020-06-02 Medimmune Limited Formulações de anticorpos monoclonais
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
TW202228779A (zh) 2022-08-01
CN117982637A (zh) 2024-05-07
KR102359181B1 (ko) 2022-02-08
JP7446356B2 (ja) 2024-03-08
ZA202006797B (en) 2023-03-29
AU2018227502A1 (en) 2019-08-15
JP2020509031A (ja) 2020-03-26
US11667698B2 (en) 2023-06-06
KR102668158B1 (ko) 2024-05-23
ECSP19062769A (es) 2019-09-30
AR111083A1 (es) 2019-05-29
US10774133B2 (en) 2020-09-15
MY206022A (en) 2024-11-25
UA128450C2 (uk) 2024-07-17
BR112019017755A2 (pt) 2020-04-07
EA201991701A1 (ru) 2020-03-04
GB2564175B (en) 2021-12-08
CN110418803B (zh) 2024-01-19
PH12019501979A1 (en) 2020-06-29
KR20220020420A (ko) 2022-02-18
AU2018227502B2 (en) 2022-08-11
US20180251526A1 (en) 2018-09-06
IL268202A (en) 2019-09-26
IL312499A (en) 2024-07-01
AU2022263564B2 (en) 2025-05-22
EP3589648A1 (en) 2020-01-08
CN116059343A (zh) 2023-05-05
JP2022095697A (ja) 2022-06-28
JP7046088B2 (ja) 2022-04-01
WO2018160722A1 (en) 2018-09-07
SG11201906853QA (en) 2019-09-27
TWI761453B (zh) 2022-04-21
MX2019010408A (es) 2019-12-19
GB201802974D0 (en) 2018-04-11
NZ755790A (en) 2024-04-26
GB2564175A (en) 2019-01-09
IL268202B1 (en) 2024-06-01
CR20190400A (es) 2019-12-03
CN110418803A (zh) 2019-11-05
CO2019009034A2 (es) 2019-08-30
IL268202B2 (en) 2024-10-01
EP3589648A4 (en) 2020-12-23
US20230399383A1 (en) 2023-12-14
TW201840334A (zh) 2018-11-16
AU2022263564A1 (en) 2022-12-15
US11286294B2 (en) 2022-03-29
US20200339667A1 (en) 2020-10-29
CL2019002478A1 (es) 2020-01-24
KR20190125318A (ko) 2019-11-06
TWI911431B (zh) 2026-01-11
US20210317191A1 (en) 2021-10-14

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