MA50663A - Formulations stables d'anticorps anti-récepteur de mort programmée 1 (pd-1) et leur utilisation - Google Patents

Formulations stables d'anticorps anti-récepteur de mort programmée 1 (pd-1) et leur utilisation

Info

Publication number
MA50663A
MA50663A MA050663A MA50663A MA50663A MA 50663 A MA50663 A MA 50663A MA 050663 A MA050663 A MA 050663A MA 50663 A MA50663 A MA 50663A MA 50663 A MA50663 A MA 50663A
Authority
MA
Morocco
Prior art keywords
receptor
programmed death
stable formulations
body stable
formulations
Prior art date
Application number
MA050663A
Other languages
English (en)
Inventor
Ashwin Basarkar
Wendy Benjamin
Soumendu Bhattacharya
William P Forrest Jr
Ramesh S Kashi
Yogita Krishnamachari
Sarita Mittal
Chakravarthy Nachu Narasimhan
Mohammed Shameem
Manoj K Sharma
Original Assignee
Merck Sharp & Dohme
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=64016286&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MA50663(A) "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 MA50663A publication Critical patent/MA50663A/fr

Links

Classifications

    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • 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
    • 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
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
MA050663A 2017-05-02 2018-05-01 Formulations stables d'anticorps anti-récepteur de mort programmée 1 (pd-1) et leur utilisation MA50663A (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201762500238P 2017-05-02 2017-05-02

Publications (1)

Publication Number Publication Date
MA50663A true MA50663A (fr) 2021-05-26

Family

ID=64016286

Family Applications (1)

Application Number Title Priority Date Filing Date
MA050663A MA50663A (fr) 2017-05-02 2018-05-01 Formulations stables d'anticorps anti-récepteur de mort programmée 1 (pd-1) et leur utilisation

Country Status (24)

Country Link
US (3) US11633476B2 (fr)
EP (1) EP3618808A4 (fr)
JP (2) JP7483376B2 (fr)
KR (1) KR20190142392A (fr)
CN (1) CN110869002A (fr)
AU (1) AU2018263862A1 (fr)
BR (1) BR112019022972A2 (fr)
CA (1) CA3062160A1 (fr)
CL (1) CL2019003142A1 (fr)
CO (1) CO2019012151A2 (fr)
CR (1) CR20190497A (fr)
DO (1) DOP2019000280A (fr)
EA (1) EA201992590A1 (fr)
EC (1) ECSP19078502A (fr)
JO (1) JOP20190260A1 (fr)
MA (1) MA50663A (fr)
MX (3) MX2019013028A (fr)
MY (1) MY202279A (fr)
NI (1) NI201900112A (fr)
PE (3) PE20240814A1 (fr)
PH (1) PH12019502484A1 (fr)
SG (1) SG11201910182RA (fr)
UA (1) UA128202C2 (fr)
WO (1) WO2018204368A1 (fr)

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IL293385A (en) 2015-08-11 2022-07-01 Omniab Inc New anti–pd–1 antibodies
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
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
JP7449243B2 (ja) * 2018-05-25 2024-03-13 ドクター レディズ ラボラトリーズ リミテッド 安定な融合タンパク質製剤
WO2020097141A1 (fr) * 2018-11-07 2020-05-14 Merck Sharp & Dohme Corp. Formulations stables d'anticorps du récepteur de mort programmé 1 (mp-1) et leurs méthodes d'utilisation
US11634485B2 (en) 2019-02-18 2023-04-25 Eli Lilly And Company Therapeutic antibody formulation
CN112203642A (zh) * 2019-03-25 2021-01-08 阿特根公司 用于皮下注射的包含人透明质酸酶ph20变体和药物的药物组合物
KR20220113355A (ko) * 2019-10-02 2022-08-12 알라맵 테라퓨틱스, 인크. 항-코넥신 항체 제제
WO2021118321A1 (fr) * 2019-12-13 2021-06-17 삼성바이오에피스 주식회사 Préparation pharmaceutique d'anticorps anti-pd-1 stable
MX2022007464A (es) * 2019-12-18 2022-06-27 Tesaro Inc Composiciones biofarmaceuticas y metodos relacionados.
EP4076511A4 (fr) * 2019-12-20 2024-02-14 Anthos Therapeutics, Inc. Formulations pharmaceutiques et schémas posologiques pour anticorps de facteur xi/xia
WO2021123202A1 (fr) 2019-12-20 2021-06-24 Formycon Ag Formulations d'anticorps anti-pd1
KR20210097882A (ko) * 2020-01-30 2021-08-10 삼성바이오에피스 주식회사 안정한 항-pd-1 항체 약제학적 제제
CA3180463A1 (fr) * 2020-06-19 2021-12-23 Ping Hu Formulation stable pour anticorps monoclonal anti-pd-1 recombinant
MX2023001160A (es) * 2020-07-31 2023-02-22 Jiangsu Hengrui Pharmaceuticals Co Ltd Composicion farmaceutica del anticuerpo anti-pd-1 y uso del mismo.
KR20230042744A (ko) * 2020-07-31 2023-03-29 알라맵 테라퓨틱스, 인크. 항-코넥신 항체 제제
CN112285224A (zh) * 2020-10-02 2021-01-29 朱吉安 一种抗pd-1单克隆抗体药物的质量标准检测方法
EP4008345A1 (fr) * 2020-12-03 2022-06-08 Hexal AG Nouvelles formulations pour des anticorps
JP2024505524A (ja) 2021-01-29 2024-02-06 メルク・シャープ・アンド・ドーム・エルエルシー プログラム死受容体1(pd-1)抗体の組成物及びその組成物を得る方法
JP2024523443A (ja) * 2021-06-21 2024-06-28 ブリストル-マイヤーズ スクイブ カンパニー 高濃度凍結乾燥生物製剤の再構成時間を減少させるためのスクロース、マンニトールおよびグリシンの使用
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JP2024525566A (ja) * 2021-07-09 2024-07-12 マクロジェニクス,インコーポレーテッド Pd‐1抗体の医薬組成物及びその使用
WO2023169986A1 (fr) 2022-03-07 2023-09-14 Mabxience Research, S.L. Formulations stables pour anticorps
WO2023198116A1 (fr) * 2022-04-14 2023-10-19 Beigene Switzerland Gmbh Formulations stables d'arginine à haute concentration contenant un anticorps pd -1 et leurs procédés d'utilisation
TW202342098A (zh) * 2022-04-14 2023-11-01 瑞士商百濟神州瑞士有限責任公司 含有pd-1抗體的穩定高濃度氯化鈉配製物及其使用方法
WO2023245048A1 (fr) * 2022-06-15 2023-12-21 Bioverativ Usa Inc. Formulation d'anticorps anti-complément c1s
WO2024006981A1 (fr) * 2022-07-01 2024-01-04 Amgen Inc. Formulations d'anticorps anti-pd -1
TW202409078A (zh) * 2022-07-18 2024-03-01 中國大陸商蘇州創勝醫藥集團有限公司 穩定之包含抗gremlin1抗體的藥物製劑
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