CN110603052A - 单独的和与程序性死亡受体1(pd-1)抗体组合的抗tigit抗体的稳定制剂及其使用方法 - Google Patents

单独的和与程序性死亡受体1(pd-1)抗体组合的抗tigit抗体的稳定制剂及其使用方法 Download PDF

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Publication number
CN110603052A
CN110603052A CN201880029167.7A CN201880029167A CN110603052A CN 110603052 A CN110603052 A CN 110603052A CN 201880029167 A CN201880029167 A CN 201880029167A CN 110603052 A CN110603052 A CN 110603052A
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formulation
seq
antibody
antigen
binding fragment
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A·德
C·N·纳拉西曼
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Merck Sharp and Dohme BV
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    • 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
    • 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
    • A61K47/20—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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/547—Chelates, e.g. Gd-DOTA or Zinc-amino acid chelates; Chelate-forming compounds, e.g. DOTA or ethylenediamine being covalently linked or complexed to the pharmacologically- or therapeutically-active agent
    • 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
    • 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
    • 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
    • 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
    • C07K16/2809—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 the T-cell receptor (TcR)-CD3 complex
    • 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
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Virology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN201880029167.7A 2017-05-02 2018-05-01 单独的和与程序性死亡受体1(pd-1)抗体组合的抗tigit抗体的稳定制剂及其使用方法 Pending CN110603052A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762500278P 2017-05-02 2017-05-02
US62/500,278 2017-05-02
PCT/US2018/030516 WO2018204405A1 (en) 2017-05-02 2018-05-01 Stable formulations of anti-tigit antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof

Publications (1)

Publication Number Publication Date
CN110603052A true CN110603052A (zh) 2019-12-20

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US (2) US20200354453A1 (https=)
EP (1) EP3618855A4 (https=)
JP (2) JP7402693B2 (https=)
KR (1) KR102770786B1 (https=)
CN (1) CN110603052A (https=)
AU (1) AU2018261080A1 (https=)
BR (1) BR112019022698A2 (https=)
CA (1) CA3061050A1 (https=)
CL (1) CL2019003145A1 (https=)
CO (1) CO2019012356A2 (https=)
IL (1) IL270175B2 (https=)
MA (1) MA50661A (https=)
MX (1) MX2019013033A (https=)
SG (2) SG10202111905PA (https=)
WO (1) WO2018204405A1 (https=)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108290936A (zh) * 2015-08-14 2018-07-17 默沙东公司 抗tigit抗体
CN111718415A (zh) * 2020-07-03 2020-09-29 上海洛启生物医药技术有限公司 一种抗tigit纳米抗体及其应用
WO2021147854A1 (zh) * 2020-01-21 2021-07-29 信达生物制药(苏州)有限公司 重组全人源抗tigit单克隆抗体制剂及其制备方法和用途
WO2021227940A1 (zh) * 2020-05-09 2021-11-18 华博生物医药技术（上海）有限公司 抗tigit的抗体、其制备方法和应用
WO2023001303A1 (zh) * 2021-07-23 2023-01-26 中山康方生物医药有限公司 药物组合物及用途
WO2023198116A1 (en) * 2022-04-14 2023-10-19 Beigene Switzerland Gmbh Stable high concentration arginine formulations containing pd-1 antibody and methods of use thereof
WO2024140651A1 (zh) * 2022-12-27 2024-07-04 上海复宏汉霖生物技术股份有限公司 包含抗tigit抗体的药物制剂
WO2025168006A1 (zh) * 2024-02-06 2025-08-14 香港北恒生物科技有限公司 工程化细胞及其用途

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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
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
RS64576B1 (sr) 2017-05-01 2023-10-31 Agenus Inc Anti-tigit antitela i postupci njihove primene
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
IL277095B2 (en) * 2018-03-07 2025-10-01 Pfizer Preparations containing anti-PD-1 antibody
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
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
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
CN113194925B (zh) * 2018-12-14 2025-03-07 莫佛塞斯公司 抗体制剂
KR102332847B1 (ko) * 2019-06-13 2021-12-01 주식회사 녹십자 Tigit에 대한 항체 및 이의 용도
EP3999537A1 (en) * 2019-07-19 2022-05-25 Ichnos Sciences SA Lyophilized antibody formulation
CN112741804A (zh) * 2019-10-31 2021-05-04 上海君实生物医药科技股份有限公司 含有抗pd-l1抗体的稳定制剂
IL294375B1 (en) * 2020-01-24 2026-02-01 Regeneron Pharma Stable antibody formulation
BR112022024221A2 (pt) * 2020-06-02 2022-12-20 Arcus Biosciences Inc Anticorpos para tigit
CN115916348A (zh) 2020-06-18 2023-04-04 基因泰克公司 使用抗tigit抗体和pd-1轴结合拮抗剂的治疗
TW202216778A (zh) 2020-07-15 2022-05-01 美商安進公司 Ｔｉｇｉｔ及ｃｄ１１２ｒ阻斷
SMT202500208T1 (it) * 2020-12-28 2025-07-22 Bristol Myers Squibb Co Composizioni anticorpali e metodi per il loro uso
JP2024501029A (ja) 2020-12-28 2024-01-10 ブリストル－マイヤーズ スクイブ カンパニー Ｐｄ１／ｐｄ－ｌ１抗体の皮下投与
AU2022207020A1 (en) * 2021-01-14 2023-08-31 Shanghai Junshi Biosciences Co., Ltd. Anti-tigit antibody pharmaceutical composition and application thereof
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
AR125753A1 (es) 2021-05-04 2023-08-09 Agenus Inc Anticuerpos anti-tigit, anticuerpos anti-cd96 y métodos de uso de estos
CN118871463A (zh) 2021-07-28 2024-10-29 基因泰克公司 用于治疗癌症的方法和组合物
TW202321308A (zh) 2021-09-30 2023-06-01 美商建南德克公司 使用抗ｔｉｇｉｔ抗體、抗ｃｄ３８抗體及ｐｄ—１軸結合拮抗劑治療血液癌症的方法
CN114106182B (zh) * 2022-01-26 2022-05-17 中山康方生物医药有限公司 抗tigit的抗体及其用途
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
EP4537107A2 (en) 2022-06-07 2025-04-16 Genentech, Inc. Method for determining the efficacy of a lung cancer treatment comprising an anti-pd-l1 antagonist and an anti-tigit antagonist antibody
US20250362305A1 (en) * 2022-08-04 2025-11-27 Merck Sharp & Dohme Llc Methods for determining one or more critical quality attributes of co-formulated antibodies
CN121003695A (zh) * 2024-05-24 2025-11-25 百奥泰生物制药股份有限公司 抗tigit抗体和抗pd-1抗体联合治疗肿瘤
WO2025248110A1 (en) 2024-05-31 2025-12-04 Replimune Limited An oncolytic herpes simplex virus (hsv) and an anti-pd-1 antibody for use in treating braf mutant melanoma

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CN108290936A (zh) * 2015-08-14 2018-07-17 默沙东公司 抗tigit抗体
CN108290936B (zh) * 2015-08-14 2022-07-12 默沙东公司 抗tigit抗体
WO2021147854A1 (zh) * 2020-01-21 2021-07-29 信达生物制药(苏州)有限公司 重组全人源抗tigit单克隆抗体制剂及其制备方法和用途
TWI782397B (zh) * 2020-01-21 2022-11-01 大陸商信達生物製藥（蘇州）有限公司 重組全人源抗ｔｉｇｉｔ單株抗體製劑及其製備方法和用途
WO2021227940A1 (zh) * 2020-05-09 2021-11-18 华博生物医药技术（上海）有限公司 抗tigit的抗体、其制备方法和应用
CN111718415A (zh) * 2020-07-03 2020-09-29 上海洛启生物医药技术有限公司 一种抗tigit纳米抗体及其应用
WO2023001303A1 (zh) * 2021-07-23 2023-01-26 中山康方生物医药有限公司 药物组合物及用途
WO2023198116A1 (en) * 2022-04-14 2023-10-19 Beigene Switzerland Gmbh Stable high concentration arginine formulations containing pd-1 antibody and methods of use thereof
WO2024140651A1 (zh) * 2022-12-27 2024-07-04 上海复宏汉霖生物技术股份有限公司 包含抗tigit抗体的药物制剂
WO2025168006A1 (zh) * 2024-02-06 2025-08-14 香港北恒生物科技有限公司 工程化细胞及其用途

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SG11201909941QA (en) 2019-11-28
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RU2019138519A (ru) 2021-06-02
US20240182573A1 (en) 2024-06-06
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US20200354453A1 (en) 2020-11-12
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AU2018261080A1 (en) 2019-11-07
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