JP2024540377A - ヒト化抗cd40抗体の医薬組成物 - Google Patents

ヒト化抗cd40抗体の医薬組成物 Download PDF

Info

Publication number
JP2024540377A
JP2024540377A JP2024526890A JP2024526890A JP2024540377A JP 2024540377 A JP2024540377 A JP 2024540377A JP 2024526890 A JP2024526890 A JP 2024526890A JP 2024526890 A JP2024526890 A JP 2024526890A JP 2024540377 A JP2024540377 A JP 2024540377A
Authority
JP
Japan
Prior art keywords
pharmaceutical composition
polysorbate
acetate
antibody
composition comprises
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
JP2024526890A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024540377A5 (https=
Inventor
クランツ,ジェームス
Original Assignee
キニクサ・ファーマシューティカルズ,ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング
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 キニクサ・ファーマシューティカルズ,ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング filed Critical キニクサ・ファーマシューティカルズ,ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング
Publication of JP2024540377A publication Critical patent/JP2024540377A/ja
Publication of JP2024540377A5 publication Critical patent/JP2024540377A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • C07K16/2878Immunoglobulins [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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/26Carbohydrates, 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2024526890A 2021-11-05 2022-11-01 ヒト化抗cd40抗体の医薬組成物 Pending JP2024540377A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163276363P 2021-11-05 2021-11-05
US63/276,363 2021-11-05
PCT/US2022/079072 WO2023081652A1 (en) 2021-11-05 2022-11-01 Pharmaceutical compositions of humanized anti-cd40 antibodies

Publications (2)

Publication Number Publication Date
JP2024540377A true JP2024540377A (ja) 2024-10-31
JP2024540377A5 JP2024540377A5 (https=) 2025-11-11

Family

ID=86242030

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024526890A Pending JP2024540377A (ja) 2021-11-05 2022-11-01 ヒト化抗cd40抗体の医薬組成物

Country Status (9)

Country Link
US (2) US20230279135A1 (https=)
EP (1) EP4426744A4 (https=)
JP (1) JP2024540377A (https=)
KR (1) KR20240095255A (https=)
CN (1) CN118382640A (https=)
AU (1) AU2022381078A1 (https=)
CA (1) CA3236827A1 (https=)
MX (1) MX2024005415A (https=)
WO (1) WO2023081652A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112018004296B1 (pt) 2015-09-04 2020-05-05 Primatope Therapeutics Inc anticorpos anti-cd40 humanizados e usos dos mesmos
US12234294B2 (en) 2021-11-05 2025-02-25 Kiniksa Pharmaceuticals, Gmbh Pharmaceutical composition of a humanized anti-CD40 antibody
US20250276092A1 (en) 2024-03-01 2025-09-04 Regeneron Pharmaceuticals, Inc. Methods and compositions for re-dosing aav using anti-cd40 antagonistic antibody to suppress host anti-aav antibody response
WO2025184603A2 (en) 2024-03-01 2025-09-04 Regeneron Pharmaceuticals, Inc. The use of cd40 inhibitors for inhibiting an immune response and enabling immunogen administration and re-administration

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR060487A1 (es) * 2006-04-21 2008-06-18 Xoma Technology Ltd Composiciones farmaceuticas de antagonistas del anticuerpo anti- cd40
BR112018004296B1 (pt) * 2015-09-04 2020-05-05 Primatope Therapeutics Inc anticorpos anti-cd40 humanizados e usos dos mesmos

Also Published As

Publication number Publication date
KR20240095255A (ko) 2024-06-25
MX2024005415A (es) 2024-07-30
EP4426744A4 (en) 2025-10-22
WO2023081652A1 (en) 2023-05-11
US20230279135A1 (en) 2023-09-07
EP4426744A1 (en) 2024-09-11
AU2022381078A1 (en) 2024-05-23
US20250282884A1 (en) 2025-09-11
CN118382640A (zh) 2024-07-23
CA3236827A1 (en) 2023-05-11

Similar Documents

Publication Publication Date Title
JP2024540377A (ja) ヒト化抗cd40抗体の医薬組成物
KR101782203B1 (ko) 동결건조 및 수성 항-cd40 항체 제제
RU2548772C2 (ru) Составы антитела
RS65845B1 (sr) Visokokoncentrovane niskoviskozne formulacije antitela koja inhibiraju masp-2, kompleti i postupci
JP2018500380A (ja) アグリコシル化治療用抗体の製剤
US20250114449A1 (en) Stable anti-osmr antibody formulation
KR102413592B1 (ko) 약학적 제형 및 그의 제조 방법
US12234294B2 (en) Pharmaceutical composition of a humanized anti-CD40 antibody
JP2024510480A (ja) 融合タンパク質の新規製剤
HK40109865A (zh) 稳定的抗osmr抗体制剂
TWI771335B (zh) 穩定藥學調配物
EP4440616A1 (en) Formulations comprising fab-peg
RU2743681C2 (ru) Состав антитела

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20251031

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20251031