HRP20191137T1 - Formulacije otopina konstruiranih anti-il-23p19 antitijela - Google Patents

Formulacije otopina konstruiranih anti-il-23p19 antitijela Download PDF

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Publication number
HRP20191137T1
HRP20191137T1 HRP20191137TT HRP20191137T HRP20191137T1 HR P20191137 T1 HRP20191137 T1 HR P20191137T1 HR P20191137T T HRP20191137T T HR P20191137TT HR P20191137 T HRP20191137 T HR P20191137T HR P20191137 T1 HRP20191137 T1 HR P20191137T1
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HR
Croatia
Prior art keywords
formulation
antibody hum13b8
hum13b8
antibody
use according
Prior art date
Application number
HRP20191137TT
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English (en)
Inventor
Ramesh S. Kashi
Aniket Badkar
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Merck Sharp & Dohme Corp.
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.)
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50934859&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20191137(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Merck Sharp & Dohme Corp. filed Critical Merck Sharp & Dohme Corp.
Publication of HRP20191137T1 publication Critical patent/HRP20191137T1/hr

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    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • 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
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • 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
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • 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
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Transplantation (AREA)
  • Pain & Pain Management (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)

Claims (10)

1. Formulacija otopina anti-IL-23p19 antitijela hum13B8-b, koja sadrži: a) najmanje 50 mg/ml anti-IL-23p19 antitijela hum13B8-b; b) 10 mM histidinskog pufera, pH 6,0; c) 0.05% polisorbata 80; i d) 7% saharoze, pri čemu navedeno antitijelo hum13B8-b sadrži: i) polipeptid lakog lanca koji sadrži sekvencu SEQ ID NO: 2; i ii) polipeptid teškog lanca koji sadrži sekvencu SEQ ID NO: 1.
2. Formulacija otopina prema patentnom zahtjevu 1 koja sadrži najmanje 80 mg/ml anti-IL-23p19 antitijela hum13B8-b.
3. Formulacija otopina prema patentnom zahtjevu 2 koja sadrži najmanje 100 mg/ml anti-IL-23p19 antitijela hum13B8-b.
4. Formulacija otopina prema patentnom zahtjevu 1 koja sadrži 80 - 120 mg/ml anti-IL-23p19 antitijela hum13B8-b.
5. Formulacija otopina prema patentnom zahtjevu 4 koja sadrži 100 mg/ml anti-IL-23p19 antitijela hum13B8-b.
6. Formulacija otopina prema bilo kojem od patentnih zahtjeva 1 - 5 za uporabu u liječenju autoimune bolesti, inflamatorne bolesti ili proliferativnog poremećaja.
7. Formulacija za uporabu prema patentnom zahtjevu 6 naznačena time što se formulacija primjenjuje potkožno.
8. Formulacija za uporabu prema patentnom zahtjevu 7 naznačena time što se potkožna primjena obavlja putem injekcije upotrebom šprica, auto-injektora, injekcijske olovke ili injekcijskog uređaja bez igle.
9. Formulacija za uporabu prema patentnom zahtjevu 6 naznačena time što se formulacija primjenjuje u kvartalnim intervalima.
10. Formulacija za uporabu prema patentnom zahtjevu 6 naznačena time što je inflamatorna bolest psorijaza.
HRP20191137TT 2012-12-13 2019-06-21 Formulacije otopina konstruiranih anti-il-23p19 antitijela HRP20191137T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261737035P 2012-12-13 2012-12-13
PCT/US2013/073825 WO2014093203A1 (en) 2012-12-13 2013-12-09 SOLUTION FORMULATIONS OF ENGINEERED ANTI-IL-23p19 ANTIBODIES
EP13863590.9A EP2931313B1 (en) 2012-12-13 2013-12-09 Solution formulations of engineered anti-il-23p19 antibodies

Publications (1)

Publication Number Publication Date
HRP20191137T1 true HRP20191137T1 (hr) 2019-09-20

Family

ID=50934859

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20191137TT HRP20191137T1 (hr) 2012-12-13 2019-06-21 Formulacije otopina konstruiranih anti-il-23p19 antitijela

Country Status (31)

Country Link
US (2) US20150329632A1 (hr)
EP (1) EP2931313B1 (hr)
JP (1) JP6266012B2 (hr)
KR (1) KR102004585B1 (hr)
CN (1) CN104870016B (hr)
AU (1) AU2013359767B2 (hr)
BR (1) BR112015013540B1 (hr)
CA (1) CA2894869C (hr)
CL (1) CL2015001608A1 (hr)
CY (1) CY1121895T1 (hr)
DK (1) DK2931313T3 (hr)
EA (1) EA034616B1 (hr)
ES (1) ES2732861T3 (hr)
HK (1) HK1215194A1 (hr)
HR (1) HRP20191137T1 (hr)
HU (1) HUE045668T2 (hr)
IL (3) IL278295B2 (hr)
LT (1) LT2931313T (hr)
MX (1) MX357936B (hr)
MY (1) MY187921A (hr)
NZ (1) NZ708443A (hr)
PE (1) PE20151524A1 (hr)
PH (1) PH12015501296B1 (hr)
PL (1) PL2931313T3 (hr)
PT (1) PT2931313T (hr)
RS (1) RS59057B1 (hr)
SI (1) SI2931313T1 (hr)
TR (1) TR201909584T4 (hr)
UA (1) UA117466C2 (hr)
WO (1) WO2014093203A1 (hr)
ZA (1) ZA201504408B (hr)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI761959B (zh) * 2014-11-07 2022-04-21 瑞士商諾華公司 治療眼部疾病之方法
TWI775827B (zh) * 2017-03-31 2022-09-01 日商明治製菓藥業股份有限公司 水性製劑及裝入注射器之水性製劑以及抗體蛋白去凝集劑及抗體蛋白去凝集方法
KR20200129125A (ko) * 2018-03-05 2020-11-17 얀센 바이오테크 인코포레이티드 항-il23 특이적 항체로 크론병을 치료하는 방법
AU2019384160A1 (en) * 2018-11-21 2021-05-27 Regeneron Pharmaceuticals, Inc. High concentration protein formulation
CA3129901A1 (en) 2019-02-18 2020-08-27 Eli Lilly And Company Therapeutic antibody formulation
EP3928101A1 (en) * 2019-02-20 2021-12-29 Amgen Inc. Methods of determining protein stability
JP2022534020A (ja) 2019-05-23 2022-07-27 ヤンセン バイオテツク,インコーポレーテツド Il-23及びtnfアルファに対する抗体の併用療法による炎症性腸疾患の治療方法
TW202123965A (zh) * 2019-09-09 2021-07-01 德商百靈佳殷格翰國際股份有限公司 抗-il-23p19抗體調配物
WO2021126435A1 (en) * 2019-12-20 2021-06-24 Novarock Biotherapeutics, Ltd. Anti-interleukin-23 p19 antibodies and methods of use thereof
AU2021272212A1 (en) * 2020-05-13 2022-12-08 Innovent Biologics (Suzhou) Co., Ltd. Formulation comprising anti-il-23p19 antibody, method for preparing same and use thereof

Family Cites Families (34)

* 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
CN100529076C (zh) 1999-09-09 2009-08-19 先灵公司 哺乳动物细胞因子、相关试剂和方法
CA2454587C (en) 2001-07-25 2012-11-13 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
WO2003039485A2 (en) * 2001-11-08 2003-05-15 Protein Design Labs Stable liquid pharmaceutical formulation of igg antibodies
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
SI3417875T1 (sl) 2003-02-10 2021-01-29 Biogen Ma Inc. Formulacija imunoglobulina in metode za njegovo pripravo
AU2004219625B9 (en) 2003-03-10 2010-12-23 Merck Sharp & Dohme Corp. Uses of IL-23 agonists and antagonists; related reagents
EP3178492A1 (en) * 2003-04-04 2017-06-14 Genentech, Inc. High concentration antibody and protein formulations
ATE533502T1 (de) 2004-02-17 2011-12-15 Schering Corp Verfahren zur modulation der il-23-aktivität; relevante reagenzien
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
PT2452694T (pt) 2005-06-30 2019-02-21 Janssen Biotech Inc Anticorpos anti-il-23, composições, métodos e utilizações
DK1937721T3 (da) 2005-08-25 2010-10-18 Lilly Co Eli Anti-IL-23 antistoffer
PL1931710T3 (pl) 2005-08-31 2017-06-30 Merck Sharp & Dohme Corp. Przeciwciała anty-il-23 skonstruowane techniką inżynierii genetycznej
PT1971366E (pt) 2005-12-29 2014-11-06 Janssen Biotech Inc Anticorpos humanos anti-il-23, composições, métodos e usos
CA2655372A1 (en) 2006-06-13 2007-12-21 Zymogenetics, Inc. Il-17 and il-23 antagonists and methods of using the same
US7705132B2 (en) 2006-10-20 2010-04-27 Amgen Inc. Stable polypeptide formulations
MX2009007406A (es) 2007-01-09 2010-01-25 Wyeth Corp Formulaciones de anticuerpo anti-il-13 y usos de las mismas.
TWI426918B (zh) 2007-02-12 2014-02-21 Merck Sharp & Dohme Il-23拮抗劑於治療感染之用途
SI2059534T1 (sl) * 2007-02-23 2012-08-31 Schering Corp Umetno proizvedena anti-il-23p19 antitelesa
CN101663320A (zh) 2007-02-23 2010-03-03 先灵公司 工程改造的抗IL-23p19抗体
US20090208492A1 (en) 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
EP2205276A4 (en) 2007-09-28 2012-08-15 Janssen 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
SI2234600T1 (sl) 2007-12-21 2014-12-31 F. Hoffmann-La Roche Ag Farmacevtska oblika protitelesa
EP3002299A1 (en) * 2008-06-03 2016-04-06 AbbVie Inc. Dual variable domain immunoglobulins and uses thereof
CN102202655B (zh) * 2008-08-27 2013-06-19 默沙东公司 基因工程抗IL-23p19抗体的冻干制剂
EP2331090B1 (en) * 2008-09-19 2018-01-03 Pfizer Inc. Stable liquid antibody formulation
AU2009319856A1 (en) * 2008-11-28 2010-06-03 Abbvie Inc. Stable antibody compositions and methods for stabilizing same
MX2012007676A (es) * 2009-12-29 2012-08-03 Hoffmann La Roche Nueva formulacion de anticuerpo.
US9220776B2 (en) 2011-03-31 2015-12-29 Merck Sharp & Dohme Corp. Stable formulations of antibodies to human programmed death receptor PD-1 and related treatments
NZ629261A (en) * 2012-03-07 2017-08-25 Cadila Healthcare Ltd Pharmaceutical formulations of tnf-alpha antibodies

Also Published As

Publication number Publication date
CY1121895T1 (el) 2020-10-14
HK1215194A1 (zh) 2016-08-19
ZA201504408B (en) 2017-09-27
MY187921A (en) 2021-10-28
PL2931313T3 (pl) 2019-10-31
JP6266012B2 (ja) 2018-01-24
KR102004585B1 (ko) 2019-07-26
IL278295A (hr) 2020-12-31
CA2894869C (en) 2021-06-15
CN104870016B (zh) 2018-05-08
BR112015013540B1 (pt) 2021-04-27
HUE045668T2 (hu) 2020-01-28
EP2931313B1 (en) 2019-05-08
BR112015013540A8 (pt) 2018-04-17
EP2931313A1 (en) 2015-10-21
KR20150092763A (ko) 2015-08-13
PH12015501296A1 (en) 2015-08-24
IL307581A (en) 2023-12-01
IL278295B2 (en) 2024-03-01
MX2015007213A (es) 2016-08-03
NZ708443A (en) 2018-05-25
IL239150A0 (en) 2015-07-30
PH12015501296B1 (en) 2015-08-24
DK2931313T3 (da) 2019-07-15
EA201591133A1 (ru) 2015-10-30
PE20151524A1 (es) 2015-11-06
WO2014093203A1 (en) 2014-06-19
EP2931313A4 (en) 2016-08-03
RS59057B1 (sr) 2019-08-30
EA034616B1 (ru) 2020-02-27
CN104870016A (zh) 2015-08-26
LT2931313T (lt) 2019-09-25
BR112015013540A2 (pt) 2017-11-14
ES2732861T3 (es) 2019-11-26
MX357936B (es) 2018-07-31
SI2931313T1 (sl) 2019-09-30
PT2931313T (pt) 2019-07-10
US20150329632A1 (en) 2015-11-19
TR201909584T4 (tr) 2019-07-22
UA117466C2 (uk) 2018-08-10
US20210188964A1 (en) 2021-06-24
IL278295B1 (en) 2023-11-01
AU2013359767A1 (en) 2015-07-23
CL2015001608A1 (es) 2015-10-30
CA2894869A1 (en) 2014-06-19
AU2013359767B2 (en) 2018-04-05
JP2016505572A (ja) 2016-02-25
IL239150B (en) 2020-11-30

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