AU2018263837B2 - Stable formulations of anti-CTLA4 antibodies alone and in combination with programmed death receptor 1 (PD-1) antibodies and methods of use thereof - Google Patents

Stable formulations of anti-CTLA4 antibodies alone and in combination with programmed death receptor 1 (PD-1) antibodies and methods of use thereof Download PDF

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Publication number
AU2018263837B2
AU2018263837B2 AU2018263837A AU2018263837A AU2018263837B2 AU 2018263837 B2 AU2018263837 B2 AU 2018263837B2 AU 2018263837 A AU2018263837 A AU 2018263837A AU 2018263837 A AU2018263837 A AU 2018263837A AU 2018263837 B2 AU2018263837 B2 AU 2018263837B2
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formulation
antibody
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AU2018263837A1 (en
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Soumendu Bhattacharya
Rubi Burlage
Jason K. Cheung
Arnab De
Chakravarthy Nachu NARASIMHAN
Manoj K. Sharma
Xiaoyu Yang
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Merck Sharp and Dohme LLC
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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
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/08—Solutions
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • 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
    • 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
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2018263837A 2017-05-02 2018-05-01 Stable formulations of anti-CTLA4 antibodies alone and in combination with programmed death receptor 1 (PD-1) antibodies and methods of use thereof Active AU2018263837B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762500268P 2017-05-02 2017-05-02
US62/500,268 2017-05-02
PCT/US2018/030420 WO2018204343A1 (en) 2017-05-02 2018-05-01 Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof

Publications (2)

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AU2018263837A1 AU2018263837A1 (en) 2019-12-05
AU2018263837B2 true AU2018263837B2 (en) 2025-02-20

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US (2) US20200262922A1 (https=)
EP (1) EP3618866A4 (https=)
JP (2) JP2020518598A (https=)
KR (1) KR102624564B1 (https=)
CN (1) CN110678199B (https=)
AU (1) AU2018263837B2 (https=)
BR (1) BR112019022695A2 (https=)
CA (1) CA3060695A1 (https=)
CL (1) CL2019003143A1 (https=)
CO (1) CO2019012143A2 (https=)
EA (1) EA201992526A1 (https=)
MA (1) MA50501A (https=)
MX (1) MX2019013034A (https=)
SG (1) SG11201910134SA (https=)
TN (1) TN2019000294A1 (https=)
UA (1) UA129862C2 (https=)
WO (1) WO2018204343A1 (https=)

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UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
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JP2020518598A (ja) * 2017-05-02 2020-06-25 メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． 単独およびプログラム死受容体１（ｐｄ−１）抗体と組み合わされた抗ｃｔｌａ４抗体の安定な製剤、ならびにその使用方法
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
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
JP2021513540A (ja) * 2018-02-13 2021-05-27 メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． 抗ｐｄ−１抗体及び抗ｃｔｌａ４抗体によるがんの処置方法
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.
EP3876978A4 (en) * 2018-11-07 2022-09-28 Merck Sharp & Dohme Corp. STABLE FORMULATIONS OF PROGRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF
EP3876990A4 (en) 2018-11-07 2023-09-06 Merck Sharp & Dohme LLC CO-FORMULATIONS OF ANTI-LAG3 ANTIBODIES AND ANTI-PD-1 ANTIBODIES
WO2020162203A1 (ja) * 2019-02-08 2020-08-13 国立大学法人東京工業大学 ホモジニアス免疫測定法に適した酵素変異体
WO2020185722A2 (en) * 2019-03-13 2020-09-17 Merck Sharp & Dohme Corp. Anti-cancer combination therapies comprising ctla-4 and pd-1 blocking agents
KR102650991B1 (ko) 2019-03-25 2024-03-27 (주)알테오젠 인간 히알루로니다제 ph20의 변이체와 약물을 포함하는 피하투여용 약학 조성물
AU2020261039A1 (en) * 2019-04-23 2021-12-09 Sanofi Anti-CD38 antibodies and formulations
JP2023500775A (ja) * 2019-09-23 2023-01-11 メルク・シャープ・アンド・ドーム・エルエルシー 宿主細胞タンパク質が減少し、ポリソルベート－８０安定性が増加した、抗ｃｔｌａ４モノクローナル抗体を含む方法および組成物
US20230118596A1 (en) * 2020-03-05 2023-04-20 Merck Sharp & Dohme Llc Methods for treating cancer using a combination of a pd-1 antagonist, a ctla4 antagonist, and lenvatinib or a pharmaceutically accpetable salt thereof
EP4153130A1 (en) * 2020-05-19 2023-03-29 F. Hoffmann-La Roche AG The use of chelators for the prevention of visible particle formation in parenteral protein solutions
MX2022016218A (es) * 2020-07-08 2023-03-31 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-ctla-4.
AU2021379882A1 (en) * 2020-11-10 2023-06-29 Sanofi Ceacam5 antibody-drug conjugate formulation
AU2022212007A1 (en) 2021-01-29 2023-09-07 Merck Sharp & Dohme Llc Compositions of programmed death receptor 1 (pd-1) antibodies and methods of obtaining the compositions thereof
EP4482868A4 (en) * 2022-02-24 2026-03-04 Merck Sharp & Dohme Llc STABLE FORMULATIONS OF A MULTIVALENT, VHH-BASED, CYTOTOXIC, T-LYMPHOCYTE-ASSOCIATED ANTIGEN 4 (CTLA4) BINDING TO HUMANE CTLA4, AND METHOD FOR USE THEREMISSION
KR20250006250A (ko) * 2022-04-29 2025-01-10 머크 샤프 앤드 돔 엘엘씨 항-pd-1 항체와 조합된 항-ilt4 항체 또는 그의 항원-결합 단편의 안정한 제제 및 그의 사용 방법
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CN110678199B (zh) 2025-02-28
JP2023109942A (ja) 2023-08-08
UA129862C2 (uk) 2025-08-27
US20200262922A1 (en) 2020-08-20
CN110678199A (zh) 2020-01-10
MA50501A (fr) 2020-09-09
US20250074985A1 (en) 2025-03-06
EA201992526A1 (ru) 2020-03-13
JP2020518598A (ja) 2020-06-25
CA3060695A1 (en) 2018-11-08
CO2019012143A2 (es) 2020-01-17
EP3618866A1 (en) 2020-03-11
WO2018204343A1 (en) 2018-11-08
BR112019022695A2 (pt) 2020-05-26
AU2018263837A1 (en) 2019-12-05
TN2019000294A1 (en) 2021-05-07
JP7653465B2 (ja) 2025-03-28
KR102624564B1 (ko) 2024-01-12
KR20190142393A (ko) 2019-12-26
MX2019013034A (es) 2020-02-05
SG11201910134SA (en) 2019-11-28
CL2019003143A1 (es) 2020-03-20
EP3618866A4 (en) 2021-07-14

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