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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (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)
  • Mycology (AREA)
  • Microbiology (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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HRP20131167T1 (hr) 2007-06-18 2014-01-03 Merck Sharp & Dohme B.V. Antitijela za humani receptor programirane smrti pd-1
HUE033369T2 (en) 2012-11-20 2017-11-28 Sanofi Sa Anti-ceacam5 antibodies and uses thereof
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
WO2018106862A1 (en) 2016-12-07 2018-06-14 Agenus Inc. Anti-ctla-4 antibodies and methods of use thereof
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
SG11201910134SA (en) * 2017-05-02 2019-11-28 Merck Sharp & Dohme Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof
JP7402693B2 (ja) * 2017-05-02 2023-12-21 メルク・シャープ・アンド・ドーム・エルエルシー 単独の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ｔｉｇｉｔ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
EP3752193A4 (en) * 2018-02-13 2022-02-23 Merck Sharp & Dohme Corp. METHODS OF TREATMENT OF CANCER WITH ANTI-PD-1 ANTIBODIES AND ANTI-CTLA4 ANTIBODIES
KR102885113B1 (ko) 2018-10-18 2025-11-13 머크 샤프 앤드 돔 엘엘씨 항-rsv 항체의 제제 및 그의 사용 방법
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
WO2020097141A1 (en) * 2018-11-07 2020-05-14 Merck Sharp & Dohme Corp. Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof
US12188063B2 (en) * 2019-02-08 2025-01-07 Institute Of Science Tokyo Enzymatic mutant suitable for homogeneous immunoassay method
EP3937979A4 (en) * 2019-03-13 2023-03-08 Merck Sharp & Dohme LLC COMBINATIONAL ANTI-CANCER THERAPIES WITH CTLA-4 AND PD-1 BLOCKING AGENTS
MY204342A (en) 2019-03-25 2024-08-24 Alteogen Inc Pharmaceutical composition, comprising human hyaluronidase ph20 variant and drug, for subcutaneous injection
TWI878289B (zh) * 2019-04-23 2025-04-01 法商賽諾菲公司 抗ｃｄ３８抗體和調配物
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
EP4114464A4 (en) * 2020-03-05 2024-05-01 Merck Sharp & Dohme LLC Methods for treating cancer using a combination of a pd-1 antagonist, a ctla4 antagonist, and lenvatinib or a pharmaceutically acceptable salt thereof
CN115812080A (zh) * 2020-07-08 2023-03-17 瑞泽恩制药公司 含有抗ctla-4抗体的稳定调配物
US12564642B2 (en) * 2020-11-10 2026-03-03 Sanofi CEACAM5 antibody-drug conjugate formulation
WO2022165001A1 (en) 2021-01-29 2022-08-04 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
AU2023259126A1 (en) * 2022-04-29 2024-10-31 Merck Sharp & Dohme Llc Stable formulations of anti-ilt4 antibodies or antigen-binding fragments thererof in combination with anti-pd-1 antibodies and methods of use thereof
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KR20250054235A (ko) * 2022-07-28 2025-04-22 머크 샤프 앤드 돔 엘엘씨 프로그램화된 사멸 수용체 1 (PD-1) 항체 및 rHuPH20 또는 그의 변이체 또는 단편의 제약 조성물

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Publication number Publication date
CO2019012143A2 (es) 2020-01-17
MX2019013034A (es) 2020-02-05
KR102624564B1 (ko) 2024-01-12
US20200262922A1 (en) 2020-08-20
EP3618866A4 (en) 2021-07-14
TN2019000294A1 (en) 2021-05-07
BR112019022695A2 (pt) 2020-05-26
CN110678199B (zh) 2025-02-28
MA50501A (fr) 2020-09-09
EA201992526A1 (ru) 2020-03-13
AU2018263837A1 (en) 2019-12-05
CN110678199A (zh) 2020-01-10
JP7653465B2 (ja) 2025-03-28
UA129862C2 (uk) 2025-08-27
SG11201910134SA (en) 2019-11-28
EP3618866A1 (en) 2020-03-11
WO2018204343A1 (en) 2018-11-08
US20250074985A1 (en) 2025-03-06
JP2023109942A (ja) 2023-08-08
CA3060695A1 (en) 2018-11-08
JP2020518598A (ja) 2020-06-25
CL2019003143A1 (es) 2020-03-20
KR20190142393A (ko) 2019-12-26

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