EP4329729A4 - Composition pharmaceutique de pembrolizumab et son utilisation - Google Patents

Composition pharmaceutique de pembrolizumab et son utilisation

Info

Publication number
EP4329729A4
EP4329729A4 EP22796265.1A EP22796265A EP4329729A4 EP 4329729 A4 EP4329729 A4 EP 4329729A4 EP 22796265 A EP22796265 A EP 22796265A EP 4329729 A4 EP4329729 A4 EP 4329729A4
Authority
EP
European Patent Office
Prior art keywords
pembrolizumab
pharmaceutical composition
pharmaceutical
composition
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP22796265.1A
Other languages
German (de)
English (en)
Other versions
EP4329729A1 (fr
Inventor
Alina Aleksandrovna KOSTANDIAN
Anastasiia Alekseevna ANDREEVA
Ekaterina Aleksandrovna LOMKOVA
Aleksandr Olegovich IAKOVLEV
Dmitry Valentinovich MOROZOV
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biocad JSC
Original Assignee
Biocad JSC
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
Priority claimed from RU2021112111A external-priority patent/RU2791857C2/ru
Application filed by Biocad JSC filed Critical Biocad JSC
Publication of EP4329729A1 publication Critical patent/EP4329729A1/fr
Publication of EP4329729A4 publication Critical patent/EP4329729A4/fr
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • 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
    • A61K9/08Solutions
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2818Immunoglobulins [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
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Oncology (AREA)
  • Genetics & Genomics (AREA)
  • Communicable Diseases (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP22796265.1A 2021-04-27 2022-04-27 Composition pharmaceutique de pembrolizumab et son utilisation Pending EP4329729A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2021112111A RU2791857C2 (ru) 2021-04-27 Фармацевтическая композиция пембролизумаба и ее применение
PCT/RU2022/050140 WO2022231481A1 (fr) 2021-04-27 2022-04-27 Composition pharmaceutique de pembrolizumab et son utilisation

Publications (2)

Publication Number Publication Date
EP4329729A1 EP4329729A1 (fr) 2024-03-06
EP4329729A4 true EP4329729A4 (fr) 2025-04-02

Family

ID=83848424

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22796265.1A Pending EP4329729A4 (fr) 2021-04-27 2022-04-27 Composition pharmaceutique de pembrolizumab et son utilisation

Country Status (14)

Country Link
EP (1) EP4329729A4 (fr)
CN (1) CN117835965A (fr)
AR (1) AR125470A1 (fr)
CL (1) CL2023003209A1 (fr)
CO (1) CO2023014166A2 (fr)
CR (1) CR20230527A (fr)
EC (1) ECSP23081880A (fr)
JO (1) JOP20230267A1 (fr)
MA (1) MA62939A1 (fr)
MX (1) MX2023012745A (fr)
PE (1) PE20250072A1 (fr)
PY (1) PY2231960A (fr)
TW (1) TW202308692A (fr)
WO (1) WO2022231481A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL322410A (en) * 2023-02-16 2025-09-01 Sun Pharmaceutical Ind Ltd Stable protein complexes containing an antibody against PD1

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018204368A1 (fr) * 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations stables d'anticorps anti-récepteur de mort programmée 1 (pd-1) et leur utilisation

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY188749A (en) * 2015-04-17 2021-12-28 Bristol Myers Squibb Co Compositions comprising a combination of nivolumab and ipilimumab
US11608357B2 (en) * 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
WO2018211517A1 (fr) * 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. Formulations de protéines à haute concentration ayant une viscosité réduite
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

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018204368A1 (fr) * 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations stables d'anticorps anti-récepteur de mort programmée 1 (pd-1) et leur utilisation

Also Published As

Publication number Publication date
MX2023012745A (es) 2023-11-09
WO2022231481A1 (fr) 2022-11-03
CN117835965A (zh) 2024-04-05
MA62939A1 (fr) 2024-02-29
CR20230527A (es) 2024-02-13
JOP20230267A1 (ar) 2023-10-26
CO2023014166A2 (es) 2024-02-05
PY2231960A (es) 2022-11-25
TW202308692A (zh) 2023-03-01
PE20250072A1 (es) 2025-01-13
AR125470A1 (es) 2023-07-19
ECSP23081880A (es) 2023-11-30
EP4329729A1 (fr) 2024-03-06
CL2023003209A1 (es) 2024-05-31

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RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 9/19 20060101ALI20250221BHEP

Ipc: A61P 35/00 20060101ALI20250221BHEP

Ipc: A61P 31/00 20060101ALI20250221BHEP

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