CA3235879A1 - Pharmaceutical formulation comprising anti-ox40 monoclonal antibody - Google Patents

Pharmaceutical formulation comprising anti-ox40 monoclonal antibody Download PDF

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Publication number
CA3235879A1
CA3235879A1 CA3235879A CA3235879A CA3235879A1 CA 3235879 A1 CA3235879 A1 CA 3235879A1 CA 3235879 A CA3235879 A CA 3235879A CA 3235879 A CA3235879 A CA 3235879A CA 3235879 A1 CA3235879 A1 CA 3235879A1
Authority
CA
Canada
Prior art keywords
pharmaceutical formulation
mmol
buffer
concentration
antibody
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
CA3235879A
Other languages
English (en)
French (fr)
Inventor
Qiang Sun
Xionghua JIN
Pengcheng FAN
Zhihao Xu
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.)
Inmagene Pte Ltd
Original Assignee
Inmagene Pte Ltd
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
Application filed by Inmagene Pte Ltd filed Critical Inmagene Pte Ltd
Publication of CA3235879A1 publication Critical patent/CA3235879A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • C07K16/2878—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 NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • A61K47/22—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
    • A61K9/0012—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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

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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
CA3235879A 2021-10-15 2022-10-13 Pharmaceutical formulation comprising anti-ox40 monoclonal antibody Pending CA3235879A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
CN2021124200 2021-10-15
CNPCT/CN2021/124200 2021-10-15
CNPCT/CN2022/118065 2022-09-09
CN2022118065 2022-09-09
PCT/CN2022/125017 WO2023061424A1 (en) 2021-10-15 2022-10-13 Pharmaceutical formulation comprising anti-ox40 monoclonal antibody

Publications (1)

Publication Number Publication Date
CA3235879A1 true CA3235879A1 (en) 2023-04-20

Family

ID=85987310

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3235879A Pending CA3235879A1 (en) 2021-10-15 2022-10-13 Pharmaceutical formulation comprising anti-ox40 monoclonal antibody

Country Status (13)

Country Link
US (1) US20250282882A1 (https=)
EP (1) EP4415754A4 (https=)
JP (1) JP2024538140A (https=)
KR (1) KR20240109250A (https=)
CN (1) CN118541166A (https=)
AU (1) AU2022367611A1 (https=)
CA (1) CA3235879A1 (https=)
CL (1) CL2024001157A1 (https=)
IL (1) IL312138A (https=)
MX (1) MX2024004619A (https=)
PE (1) PE20241351A1 (https=)
TW (1) TW202323280A (https=)
WO (1) WO2023061424A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20230255A1 (es) * 2020-04-17 2023-02-07 Hutchison Medipharma Ltd Anticuerpo anti-ox40 y usos del mismo
TW202600166A (zh) * 2024-03-04 2026-01-01 新加坡商創響私人有限公司 包含ｏｘ４０靶向抗體的藥物組合物及其用途

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20100014588A (ko) * 2007-02-27 2010-02-10 제넨테크, 인크. 길항제 ｏｘ40 항체 및 염증성 및 자가면역 질환의 치료에서의 이의 용도
SG11201607969XA (en) * 2014-03-31 2016-10-28 Genentech Inc Anti-ox40 antibodies and methods of use
WO2017134292A1 (en) * 2016-02-04 2017-08-10 Glenmark Pharmaceuticals S.A. Anti-ox40 antagonistic antibodies for the treatment of atopic dermatitis
WO2020016417A1 (en) * 2018-07-19 2020-01-23 Ichnos Sciences S.A. Liquid antibody formulation
WO2020063668A1 (zh) * 2018-09-25 2020-04-02 信达生物制药(苏州)有限公司 包含抗ox40抗体的制剂、其制备方法及其用途
US20220273796A1 (en) * 2019-07-19 2022-09-01 Ichnos Sciences SA Lyophilized antibody formulation
WO2021190582A1 (zh) * 2020-03-25 2021-09-30 江苏恒瑞医药股份有限公司 一种抗ox40抗体药物组合物及其用途

Also Published As

Publication number Publication date
MX2024004619A (es) 2024-07-12
TW202323280A (zh) 2023-06-16
CL2024001157A1 (es) 2024-11-15
WO2023061424A1 (en) 2023-04-20
AU2022367611A1 (en) 2024-05-02
KR20240109250A (ko) 2024-07-10
US20250282882A1 (en) 2025-09-11
IL312138A (en) 2024-06-01
EP4415754A1 (en) 2024-08-21
JP2024538140A (ja) 2024-10-18
PE20241351A1 (es) 2024-07-03
CN118541166A (zh) 2024-08-23
EP4415754A4 (en) 2025-09-24

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