CO2019012356A2 - Formulaciones estables de anticuerpos anti-tigit solos y en combinación con anticuerpos receptores de muerte programada 1 (pd-1) y métodos para su uso - Google Patents

Formulaciones estables de anticuerpos anti-tigit solos y en combinación con anticuerpos receptores de muerte programada 1 (pd-1) y métodos para su uso

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Publication number
CO2019012356A2
CO2019012356A2 CONC2019/0012356A CO2019012356A CO2019012356A2 CO 2019012356 A2 CO2019012356 A2 CO 2019012356A2 CO 2019012356 A CO2019012356 A CO 2019012356A CO 2019012356 A2 CO2019012356 A2 CO 2019012356A2
Authority
CO
Colombia
Prior art keywords
antibodies
methods
programmed death
death receptor
combination
Prior art date
Application number
CONC2019/0012356A
Other languages
English (en)
Inventor
Arnab De
Chakravarthy Nachu Narasimhan
Original Assignee
Merck Sharp & Dohme
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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=64016405&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO2019012356(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Merck Sharp & Dohme filed Critical Merck Sharp & Dohme
Publication of CO2019012356A2 publication Critical patent/CO2019012356A2/es

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/54Medicinal 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
    • A61K47/547Chelates, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], 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
    • C07K16/2809Immunoglobulins [IGs], 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], 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
    • C07K16/2818Immunoglobulins [IGs], 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507Comprising a combination of two or more separate antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against 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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Mycology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Virology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La presente invención se refiere a formulaciones estables de anticuerpos contra receptores de linfocitos T con dominios Ig e ITIM (TIGIT), que opcionalmente además contienen un anticuerpo anti receptor de muerte programada 1 humana (PD-1) o un fragmento de fijación al antígeno de este. También se proporcionan métodos para tratar varios tipos de cáncer e infecciones crónicas con las formulaciones de la invención.
CONC2019/0012356A 2017-05-02 2019-11-01 Formulaciones estables de anticuerpos anti-tigit solos y en combinación con anticuerpos receptores de muerte programada 1 (pd-1) y métodos para su uso CO2019012356A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762500278P 2017-05-02 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
CO2019012356A2 true CO2019012356A2 (es) 2020-01-17

Family

ID=64016405

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2019/0012356A CO2019012356A2 (es) 2017-05-02 2019-11-01 Formulaciones estables de anticuerpos anti-tigit solos y en combinación con anticuerpos receptores de muerte programada 1 (pd-1) y métodos para su uso

Country Status (15)

Country Link
US (2) US20200354453A1 (es)
EP (1) EP3618855A4 (es)
JP (2) JP7402693B2 (es)
KR (1) KR20190142394A (es)
CN (1) CN110603052A (es)
AU (1) AU2018261080A1 (es)
BR (1) BR112019022698A2 (es)
CA (1) CA3061050A1 (es)
CL (1) CL2019003145A1 (es)
CO (1) CO2019012356A2 (es)
IL (1) IL270175B2 (es)
MA (1) MA50661A (es)
MX (1) MX2019013033A (es)
SG (2) SG11201909941QA (es)
WO (1) WO2018204405A1 (es)

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KR101562580B1 (ko) 2007-06-18 2015-10-22 머크 샤프 앤 도메 비.브이. 사람 프로그램된 사멸 수용체 pd-1에 대한 항체
CN108290936B (zh) * 2015-08-14 2022-07-12 默沙东公司 抗tigit抗体
MA50957A (fr) 2017-05-01 2020-10-14 Agenus Inc Anticorps anti-tigit et leurs méthodes d'utilisation
CN110913906A (zh) 2017-05-02 2020-03-24 默沙东公司 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂
JP7312188B2 (ja) * 2018-03-07 2023-07-20 ファイザー・インク 抗pd-1抗体組成物
EP3876978A4 (en) * 2018-11-07 2022-09-28 Merck Sharp & Dohme Corp. STABLE FORMULATIONS OF PROGRAMMED DEATH RECEPTOR 1 (MP-1) ANTIBODIES AND THEIR METHODS OF USE
US20220110872A1 (en) * 2018-12-14 2022-04-14 Morphosys Ag Antibody formulations
CN113840840A (zh) * 2019-06-13 2021-12-24 株式会社绿十字 Tigit抗体及其用途
WO2021013689A1 (en) * 2019-07-19 2021-01-28 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
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
US20210252146A1 (en) * 2020-01-24 2021-08-19 Regeneron Pharmaceuticals, Inc. Stable antibody formulation
CN114507284B (zh) * 2020-05-09 2023-05-26 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
AU2021293507A1 (en) 2020-06-18 2023-02-02 F. Hoffmann-La Roche Ag Treatment with anti-TIGIT antibodies and PD-1 axis binding antagonists
CN111718415B (zh) * 2020-07-03 2021-02-23 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
TW202216778A (zh) 2020-07-15 2022-05-01 美商安進公司 Tigit及cd112r阻斷
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
TW202304965A (zh) 2021-05-04 2023-02-01 美商艾吉納斯公司 抗tigit抗體、抗cd96抗體及其使用方法
US20240352153A1 (en) * 2021-07-23 2024-10-24 Akeso Biopharma, Inc Pharmaceutical composition and use
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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
TW202345902A (zh) * 2022-04-14 2023-12-01 瑞士商百濟神州瑞士有限責任公司 含有pd-1抗體的穩定高濃度精胺酸配製物及其使用方法
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Also Published As

Publication number Publication date
MX2019013033A (es) 2020-02-05
IL270175B1 (en) 2023-05-01
WO2018204405A1 (en) 2018-11-08
AU2018261080A1 (en) 2019-11-07
CA3061050A1 (en) 2018-11-08
JP7402693B2 (ja) 2023-12-21
CL2019003145A1 (es) 2020-07-10
SG11201909941QA (en) 2019-11-28
JP2020518600A (ja) 2020-06-25
CN110603052A (zh) 2019-12-20
US20240182573A1 (en) 2024-06-06
RU2019138519A (ru) 2021-06-02
BR112019022698A2 (pt) 2020-05-19
KR20190142394A (ko) 2019-12-26
JP2024016177A (ja) 2024-02-06
SG10202111905PA (en) 2021-12-30
RU2019138519A3 (es) 2021-08-30
US20200354453A1 (en) 2020-11-12
IL270175B2 (en) 2023-09-01
EP3618855A4 (en) 2021-02-17
MA50661A (fr) 2020-08-05
EP3618855A1 (en) 2020-03-11
IL270175A (es) 2019-12-31

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