CN104870016B - 工程化的抗IL-23p19抗体的溶液制剂 - Google Patents

工程化的抗IL-23p19抗体的溶液制剂 Download PDF

Info

Publication number
CN104870016B
CN104870016B CN201380065606.7A CN201380065606A CN104870016B CN 104870016 B CN104870016 B CN 104870016B CN 201380065606 A CN201380065606 A CN 201380065606A CN 104870016 B CN104870016 B CN 104870016B
Authority
CN
China
Prior art keywords
antibody
hum13b8
antibodies
formulations
sequence
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.)
Active
Application number
CN201380065606.7A
Other languages
English (en)
Chinese (zh)
Other versions
CN104870016A (zh
Inventor
拉梅什·S.·嘉志
阿尼凯特·巴达卡
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.)
Merck Sharp and Dohme BV
Original Assignee
Merck Sharp and Dohme 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50934859&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN104870016(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Merck Sharp and Dohme Ltd filed Critical Merck Sharp and Dohme Ltd
Publication of CN104870016A publication Critical patent/CN104870016A/zh
Application granted granted Critical
Publication of CN104870016B publication Critical patent/CN104870016B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • 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)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
CN201380065606.7A 2012-12-13 2013-12-09 工程化的抗IL-23p19抗体的溶液制剂 Active CN104870016B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261737035P 2012-12-13 2012-12-13
US61/737,035 2012-12-13
PCT/US2013/073825 WO2014093203A1 (en) 2012-12-13 2013-12-09 SOLUTION FORMULATIONS OF ENGINEERED ANTI-IL-23p19 ANTIBODIES

Publications (2)

Publication Number Publication Date
CN104870016A CN104870016A (zh) 2015-08-26
CN104870016B true CN104870016B (zh) 2018-05-08

Family

ID=50934859

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201380065606.7A Active CN104870016B (zh) 2012-12-13 2013-12-09 工程化的抗IL-23p19抗体的溶液制剂

Country Status (31)

Country Link
US (3) US20150329632A1 (enExample)
EP (1) EP2931313B1 (enExample)
JP (1) JP6266012B2 (enExample)
KR (1) KR102004585B1 (enExample)
CN (1) CN104870016B (enExample)
AU (1) AU2013359767B2 (enExample)
BR (1) BR112015013540B1 (enExample)
CA (1) CA2894869C (enExample)
CL (1) CL2015001608A1 (enExample)
CY (1) CY1121895T1 (enExample)
DK (1) DK2931313T3 (enExample)
EA (1) EA034616B1 (enExample)
ES (1) ES2732861T3 (enExample)
HR (1) HRP20191137T1 (enExample)
HU (1) HUE045668T2 (enExample)
IL (3) IL278295B2 (enExample)
LT (1) LT2931313T (enExample)
MX (1) MX357936B (enExample)
MY (1) MY187921A (enExample)
NZ (1) NZ708443A (enExample)
PE (1) PE20151524A1 (enExample)
PH (1) PH12015501296A1 (enExample)
PL (1) PL2931313T3 (enExample)
PT (1) PT2931313T (enExample)
RS (1) RS59057B1 (enExample)
SI (1) SI2931313T1 (enExample)
SM (1) SMT201900414T1 (enExample)
TR (1) TR201909584T4 (enExample)
UA (1) UA117466C2 (enExample)
WO (1) WO2014093203A1 (enExample)
ZA (1) ZA201504408B (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI738632B (zh) 2014-11-07 2021-09-11 瑞士商諾華公司 穩定的含有高濃度抗vegf抗體之蛋白質溶液調配物
WO2018181876A1 (ja) * 2017-03-31 2018-10-04 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 水性製剤及び注射器入り水性製剤、並びに、抗体タンパク脱凝集剤及び抗体タンパク脱凝集方法
JP7516250B2 (ja) 2018-03-05 2024-07-16 ヤンセン バイオテツク，インコーポレーテツド 抗ｉｌ－２３特異的抗体を用いたクローン病の治療方法
CA3118306A1 (en) 2018-11-21 2020-05-28 Regeneron Pharmaceuticals, Inc. High concentration protein formulation
US12098195B2 (en) 2018-11-27 2024-09-24 Innovent Biologics (Suzhou) Co., Ltd. Anti-IL-23p19 antibody and use thereof in treating diseases
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
JP7530376B2 (ja) * 2019-02-20 2024-08-07 アムジエン・インコーポレーテツド タンパク質の安定性を決定する方法
MX2021012652A (es) * 2019-04-15 2022-01-24 Sun Pharmaceutical Ind Ltd Metodos para el tratamiento de sujetos con artritis psoriasica.
MX2021014302A (es) 2019-05-23 2022-01-04 Janssen Biotech Inc Metodo para tratar la enfermedad inflamatoria del intestino con una terapia de combinacion de anticuerpos contra il-23 y tnf alfa.
TW202535466A (zh) * 2019-09-09 2025-09-16 德商百靈佳殷格翰國際股份有限公司 抗-il-23p19抗體調配物
CN115135671A (zh) * 2019-12-20 2022-09-30 新石生物制药有限公司 抗白介素-23 p19的抗体及其使用方法
JP2023525825A (ja) * 2020-05-13 2023-06-19 イノベント バイオロジクス（スーチョウ）カンパニー，リミティド 抗ＩＬ－２３ｐ１９抗体を含む製剤、その調製方法および使用
CN115768466A (zh) 2020-05-21 2023-03-07 詹森生物科技公司 用抗IL-23和TNFα抗体的联合疗法治疗炎性肠病的方法
WO2025071362A1 (ko) * 2023-09-27 2025-04-03 삼성바이오에피스 주식회사 항-il-23 항체의 안정한 액상 제형

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1612689A (zh) * 2001-11-08 2005-05-04 蛋白质设计实验室股份有限公司 IgG抗体稳定的液态药物制剂
CN102159204A (zh) * 2008-09-19 2011-08-17 辉瑞公司 稳定的液体抗体制剂
CN102202655A (zh) * 2008-08-27 2011-09-28 先灵公司 基因工程抗IL-23p19抗体的冻干制剂
CN102301235A (zh) * 2008-11-28 2011-12-28 雅培制药有限公司 稳定的抗体组合物和用于稳定其的方法

Family Cites Families (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE60041393D1 (de) 1999-03-11 2009-03-05 Schering Corp Cytokine aus säugetieren, verwandte reagenzien und verfahren
ES2300276T5 (es) 1999-09-09 2017-06-02 Merck Sharp & Dohme Corp. P40 de interleuquina-12 de mamífero e interleuquina B30. Sus combinaciones. Anticuerpos. Usos en composiciones farmacéuticas
JP4317010B2 (ja) 2001-07-25 2009-08-19 ピーディーエル バイオファーマ，インコーポレイティド ＩｇＧ抗体の安定な凍結乾燥医薬製剤
US7132100B2 (en) 2002-06-14 2006-11-07 Medimmune, Inc. Stabilized liquid anti-RSV antibody formulations
WO2004071517A2 (en) 2003-02-06 2004-08-26 Schering Corporation Uses of il-23 related reagents
EP1592440A4 (en) 2003-02-10 2007-07-11 Elan Pharm Inc IMMUNOGLOBULIN PREPARATION AND METHOD OF PRODUCING THE SAME
TWI439285B (zh) 2003-03-10 2014-06-01 Merck Sharp & Dohme Ｉｌ－２３激動劑及拮抗劑之用途及相關試劑
HRP20050934B1 (hr) * 2003-04-04 2014-09-26 Genentech, Inc. Formulacije s visokom koncentracijom antitijela i proteina
JP4903061B2 (ja) 2004-02-17 2012-03-21 シェーリング コーポレイション Ｉｌ−２３活性を調節する方法；関連する試薬
CA2562771C (en) 2004-04-12 2013-04-09 Medimmune, Inc. Anti-il-9 antibody formulations and uses thereof
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
GT200600031A (es) 2005-01-28 2006-08-29 Formulacion anticuerpo anti a beta
PT1896073E (pt) 2005-06-30 2013-05-28 Janssen Biotech Inc Composições, métodos e aplicações de anticorpos anti-il-23
ES2347690T3 (es) 2005-08-25 2010-11-03 Eli Lilly And Company Anticuerpos anti-il-23.
ME02705B (me) 2005-08-31 2017-10-20 Merck Sharp & Dohme Inženjerisana anti-il-23 antitela
PT2548577T (pt) 2005-12-29 2017-05-29 Janssen Biotech Inc Anticorpos humanos anti-il-23, composições, métodos e usos
JP2009540018A (ja) 2006-06-13 2009-11-19 ザイモジェネティクス， インコーポレイテッド Ｉｌ−１７およびｉｌ−２３アンタゴニストならびにその使用方法
TW200833357A (en) 2006-10-20 2008-08-16 Amgen Inc Stable polypeptide formulations
TW200837080A (en) 2007-01-09 2008-09-16 Wyeth Corp Anti-IL-13 antibody formulations and uses thereof
TWI426918B (zh) 2007-02-12 2014-02-21 Merck Sharp & Dohme Ｉｌ-２３拮抗劑於治療感染之用途
SI2426144T1 (sl) 2007-02-23 2019-02-28 Merck Sharp & Dohme Corp. Umetno proizvedena anti-IL23P19 antitelesa
CN101663320A (zh) 2007-02-23 2010-03-03 先灵公司 工程改造的抗IL-23p19抗体
WO2008121615A2 (en) * 2007-03-30 2008-10-09 Medimmune, Inc. Antibody formulation
US20090208492A1 (en) 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
WO2009114040A2 (en) 2007-09-28 2009-09-17 Centocor Ortho Biotech Inc. Anti-il-12/23p40 antibodies, epitopes, formulations, compositions, methods and uses
AR068723A1 (es) 2007-10-05 2009-12-02 Glaxo Group Ltd Proteina que se une a antigenos que se une a il-23 humana y sus usos
AU2008340429C1 (en) 2007-12-21 2016-09-08 F. Hoffmann-La Roche Ag Antibody formulation
BRPI0913406A2 (pt) * 2008-06-03 2018-01-09 Abbott Lab imunoglobulinas de domínio variável duplo e usos das mesmas
CA2783715A1 (en) * 2009-12-29 2011-07-07 F. Hoffmann-La Roche Ag Novel antibody formulation
AU2012236479B2 (en) 2011-03-31 2016-10-20 Merck Sharp & Dohme Llc Stable formulations of antibodies to human programmed death receptor PD-1 and related treatments
MX363700B (es) * 2012-03-07 2019-03-29 Cadila Healthcare Ltd Formulaciones farmaceuticas de anticuerpos tnf-alfa.

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1612689A (zh) * 2001-11-08 2005-05-04 蛋白质设计实验室股份有限公司 IgG抗体稳定的液态药物制剂
CN102202655A (zh) * 2008-08-27 2011-09-28 先灵公司 基因工程抗IL-23p19抗体的冻干制剂
CN102159204A (zh) * 2008-09-19 2011-08-17 辉瑞公司 稳定的液体抗体制剂
CN102301235A (zh) * 2008-11-28 2011-12-28 雅培制药有限公司 稳定的抗体组合物和用于稳定其的方法

Also Published As

Publication number Publication date
EP2931313B1 (en) 2019-05-08
BR112015013540A8 (pt) 2018-04-17
ZA201504408B (en) 2017-09-27
KR102004585B1 (ko) 2019-07-26
SMT201900414T1 (it) 2019-09-09
US20210188964A1 (en) 2021-06-24
MY187921A (en) 2021-10-28
PH12015501296B1 (en) 2015-08-24
IL239150A0 (en) 2015-07-30
PH12015501296A1 (en) 2015-08-24
IL278295B1 (en) 2023-11-01
BR112015013540A2 (pt) 2017-11-14
EA201591133A1 (ru) 2015-10-30
EP2931313A1 (en) 2015-10-21
HRP20191137T1 (hr) 2019-09-20
BR112015013540B1 (pt) 2021-04-27
PT2931313T (pt) 2019-07-10
US20150329632A1 (en) 2015-11-19
IL278295B2 (en) 2024-03-01
HUE045668T2 (hu) 2020-01-28
SI2931313T1 (sl) 2019-09-30
CA2894869A1 (en) 2014-06-19
RS59057B1 (sr) 2019-08-30
IL239150B (en) 2020-11-30
NZ708443A (en) 2018-05-25
LT2931313T (lt) 2019-09-25
EP2931313A4 (en) 2016-08-03
ES2732861T3 (es) 2019-11-26
DK2931313T3 (da) 2019-07-15
KR20150092763A (ko) 2015-08-13
CY1121895T1 (el) 2020-10-14
AU2013359767B2 (en) 2018-04-05
CL2015001608A1 (es) 2015-10-30
UA117466C2 (uk) 2018-08-10
EA034616B1 (ru) 2020-02-27
PE20151524A1 (es) 2015-11-06
CN104870016A (zh) 2015-08-26
MX2015007213A (es) 2016-08-03
AU2013359767A1 (en) 2015-07-23
TR201909584T4 (tr) 2019-07-22
US20240239884A1 (en) 2024-07-18
JP2016505572A (ja) 2016-02-25
MX357936B (es) 2018-07-31
JP6266012B2 (ja) 2018-01-24
WO2014093203A1 (en) 2014-06-19
PL2931313T3 (pl) 2019-10-31
CA2894869C (en) 2021-06-15
HK1215194A1 (en) 2016-08-19
IL307581A (en) 2023-12-01
IL278295A (enExample) 2020-12-31

Similar Documents

Publication Publication Date Title
US20240239884A1 (en) SOLUTION FORMULATIONS OF ENGINEERED ANTI-IL-23p19 ANTIBODIES
JP6878524B2 (ja) Ｉｌ−１７抗体の医薬製品および安定した液体組成物
JP5931442B2 (ja) 操作された抗ＩＬ−２３ｐ１９抗体の凍結乾燥製剤
JP2020500195A (ja) アフリベルセプト製剤及びその使用
US20180008707A1 (en) Stable liquid formulation for monoclonal antibodies
CN105051064A (zh) 抗TNF-α抗原结合蛋白
TWI802882B (zh) 包含抗IL-23p19抗體的製劑、其製備方法和用途
HK1215194B (en) Solution formulations of engineered anti-il-23p19 antibodies
HK40059591A (en) Preparations containing anti-cd47 antibody, and preparation method and use therefor

Legal Events

Date Code Title Description
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant
TR01 Transfer of patent right

Effective date of registration: 20230518

Address after: new jersey

Patentee after: MERCK SHARP & DOHME B.V.

Address before: new jersey

Patentee before: MERCK SHARP & DOHME LTD.

TR01 Transfer of patent right