HRP20201013T1 - Liječenje autoimunih poremećaja protutijelima protiv cd154 - Google Patents

Liječenje autoimunih poremećaja protutijelima protiv cd154 Download PDF

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Publication number
HRP20201013T1
HRP20201013T1 HRP20201013TT HRP20201013T HRP20201013T1 HR P20201013 T1 HRP20201013 T1 HR P20201013T1 HR P20201013T T HRP20201013T T HR P20201013TT HR P20201013 T HRP20201013 T HR P20201013T HR P20201013 T1 HRP20201013 T1 HR P20201013T1
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Croatia
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treatment
specifically binds
autoimmune
neurodegenerative
inflammatory
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HRP20201013TT
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English (en)
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Ruth Oliver
Miren ZAMACONA
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Ucb Biopharma Sprl
Biogen Ma Inc.
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Publication of HRP20201013T1 publication Critical patent/HRP20201013T1/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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • 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
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • 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
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/35Valency
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
    • 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
    • C07K2317/565Complementarity determining region [CDR]
    • 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
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Genetics & Genomics (AREA)
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  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
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  • Biomedical Technology (AREA)
  • Diabetes (AREA)
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  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
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  • Urology & Nephrology (AREA)
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Claims (9)

1. Jednovalentni Fab’ fragment protutijela koje se specifično veže na CD154, namijenjen upotrebi u postupku liječenja autoimunog, upalnog, neurodegenerativnog ili neuromuskularnog poremećaja kod ljudskog subjekta, naznačen time što se postupak sastoji u: a) primjeni početne doze punjenja od 20-60 mg/kg navedenog fragmenta protutijela koje se specifično veže na CD154 na ljudskom subjektu kojem je potrebno takvo liječenje; i b) 2 tjedana nakon početne doze punjenja primjeni daljnje doze ili doza upola manjih od početne doze punjenja, uz učestalost od jednom u svaka dva tjedna navedenog fragmenta protutijela koje se specifično veže na CD154 na subjektu kojem je potrebno takvo liječenje, gdje navedeni fragment protutijela ima slijed lakog lanca prikazan u SEQ ID NO:9 i sljedove teškog lanca prikazane u SEQ ID NO:10, i gdje navedeni fragment protutijela ima i) maleimidnu skupinu kovalentno vezanu na jednu tiolnu skupinu u modificiranom području zgloba, te lizinski ostatak kovalentno vezan na maleimidnu skupinu; i ii) metoksipoli(etilenglikol)ni polimer molekulske težine od otprilike 20 kDa, vezan na svaku od aminskih skupina u lizinskom ostatku.
2. Jednovalentni Fab’ fragment protutijela koje se specifično veže na CD 154, namijenjen upotrebi u postupku liječenja autoimunog, upalnog, neurodegenerativnog ili neuromuskularnog poremećaja u skladu s patentnim zahtjevom 1, naznačen time što je početna doza punjenja 30 mg/kg, a daljnja doza je 15 mg/kg.
3. Jednovalentni Fab’ fragment protutijela koje se specifično veže na CD154, namijenjen upotrebi u postupku liječenja autoimunog, upalnog, neurodegenerativnog ili neuromuskularnog poremećaja u skladu s patentnim zahtjevom 1 ili 2, naznačen time što se fragment protutijela koje se specifično veže na CD154 primijenjuje na pacijentu kojem je to potrebno u najmanju ruku u trajanju od 12 tjedana.
4. Jednovalentni Fab’ fragment protutijela koje se specifično veže na CD154, namijenjen upotrebi u postupku liječenja autoimunog, upalnog, neurodegenerativnog ili neuromuskularnog poremećaja kod ljudskog subjekta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je bolest sistemni eritematozni lupus (SLE), lupozni nefritis, reumatoidni artritis, seronegativne spondiloartropatije, psorijaza, psorijatični artritis, skleroderma, Sjögrenov sindrom, multipla skleroza, dijabetes tip I, autoimuni uveitis i nefrotski sindrom ili vaskulitis.
5. Jednovalentni Fab’ fragment protutijela koje se specifično veže na CD154, namijenjen upotrebi u postupku liječenja autoimunog, upalnog, neurodegenerativnog ili neuromuskularnog poremećaja kod ljudskog subjekta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni poremećaj sistemni eritematozni lupus (SLE), te što liječeni subjekt postiže poboljšanje u odnosu na polazne vrijednosti of one ili more of the indices selected from SLEDAI, BILAG i Global Physician assessment.
6. Jednovalentni Fab’ fragment protutijela koje se specifično veže na CD154, namijenjen upotrebi u postupku liječenja autoimunog, upalnog, neurodegenerativnog ili neuromuskularnog poremećaja kod ljudskog subjekta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni poremećaj sistemni eritematozni lupus (SLE), te što liječeni subjekt postiže SLEDAI Responder Index 4 (SRI-4).
7. Jednovalentni Fab’ fragment protutijela koje se specifično veže na CD154, namijenjen upotrebi u postupku liječenja autoimunog, upalnog, neurodegenerativnog ili neuromuskularnog poremećaja kod ljudskog subjekta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni poremećaj sistemni eritematozni lupus (SLE), te što liječeni subjekt postiže 50%-tno poboljšanje u odnosu na polazne vrijednosti indeksa SRI-50.
8. Jednovalentni Fab’ fragment protutijela koje se specifično veže na CD154, namijenjen upotrebi u postupku liječenja autoimunog, upalnog, neurodegenerativnog ili neuromuskularnog poremećaja kod ljudskog subjekta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni poremećaj sistemni eritematozni lupus (SLE), te što liječeni subjekt postiže povećanje od 20%, 30%, 40%, 50%, 75% ili 90% u odnosu na polazne vrijednosti ili normaliziranje koncentracije komplementa C3 i C4, ili smanjenje od 20%, 30%, 40%, 50%, 75% ili 90% titra protutijela protiv dvolančane DNA u serumu.
9. Jednovalentni Fab’ fragment protutijela koje se specifično veže na CD154, namijenjen upotrebi u postupku liječenja autoimunog, upalnog, neurodegenerativnog ili neuromuskularnog poremećaja kod ljudskog subjekta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni poremećaj sistemni eritematozni lupus (SLE), te što se subjekt vraća od seropozitivnog u seronegativnog na protutijela protiv dvolančane DNA.
HRP20201013TT 2015-01-30 2020-06-26 Liječenje autoimunih poremećaja protutijelima protiv cd154 HRP20201013T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1501613.2A GB201501613D0 (en) 2015-01-30 2015-01-30 Treatment of autoimmune disorders with CD154 antibodies
EP15719675.9A EP3250600B1 (en) 2015-01-30 2015-04-27 Treatment of autoimmune disorders with cd154 antibodies
PCT/EP2015/059095 WO2016119909A1 (en) 2015-01-30 2015-04-27 Treatment of autoimmune disorders with cd154 antibodies

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HRP20201013T1 true HRP20201013T1 (hr) 2020-10-16

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EP (2) EP3250600B1 (hr)
KR (1) KR102543877B1 (hr)
CN (1) CN107206075A (hr)
AU (2) AU2015379642B2 (hr)
CA (1) CA2975336C (hr)
CY (1) CY1123116T1 (hr)
DK (1) DK3250600T3 (hr)
ES (1) ES2802982T3 (hr)
GB (1) GB201501613D0 (hr)
HR (1) HRP20201013T1 (hr)
HU (1) HUE050024T2 (hr)
LT (1) LT3250600T (hr)
NZ (1) NZ733454A (hr)
PL (1) PL3250600T3 (hr)
PT (1) PT3250600T (hr)
RS (1) RS60575B1 (hr)
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FI3556774T3 (fi) 2011-03-11 2024-03-15 Beth Israel Deaconess Medical Ct Inc Anti-cd40-vasta-aineita ja niiden käyttötapoja
SI3307322T1 (sl) 2015-09-04 2021-08-31 Primatope Therapeutics Inc. Humanizirana protitelesa proti CD40 in njihove uporabe
US11099185B2 (en) * 2016-02-29 2021-08-24 Maintect Gmbh Predictive markers useful in the treatment of wet age-related macular degeneration
WO2020068723A1 (en) * 2018-09-24 2020-04-02 Janssen Biotech, Inc. Method of providing safe administration of an anti-cd154 antibody
CN113447659B (zh) * 2021-07-01 2022-05-17 浙江大学 一种检测抗蛋白酶体亚基α1-IgG抗体的试剂盒
WO2023099607A1 (en) * 2021-12-01 2023-06-08 UCB Biopharma SRL Formulations comprising fab-peg

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US5179017A (en) 1980-02-25 1993-01-12 The Trustees Of Columbia University In The City Of New York Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials
GB8308235D0 (en) 1983-03-25 1983-05-05 Celltech Ltd Polypeptides
GB9625640D0 (en) 1996-12-10 1997-01-29 Celltech Therapeutics Ltd Biological products
AU8867501A (en) * 2000-09-01 2002-03-13 Biogen Inc Co-crystal structure of monoclonal antibody 5c8 and cd154, and use thereof in drug design
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CN101679521B (zh) 2007-03-22 2014-03-12 拜奥根Idec马萨诸塞公司 特异性结合cd154的包括抗体、抗体衍生物和抗体片段在内的结合蛋白及其用途
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Publication number Publication date
WO2016119909A1 (en) 2016-08-04
KR102543877B1 (ko) 2023-06-14
GB201501613D0 (en) 2015-03-18
KR20170106476A (ko) 2017-09-20
US20210324095A1 (en) 2021-10-21
AU2015379642A1 (en) 2017-07-27
US11884737B2 (en) 2024-01-30
RU2695443C2 (ru) 2019-07-23
RU2017130464A3 (hr) 2019-02-28
CA2975336C (en) 2022-10-18
EP3250600A1 (en) 2017-12-06
CN107206075A (zh) 2017-09-26
CY1123116T1 (el) 2021-10-29
US20180022812A1 (en) 2018-01-25
PL3250600T3 (pl) 2020-09-21
SI3250600T1 (sl) 2020-09-30
AU2022200347A1 (en) 2022-02-17
RU2017130464A (ru) 2019-02-28
PT3250600T (pt) 2020-06-17
CA2975336A1 (en) 2016-08-04
EP3744735A1 (en) 2020-12-02
NZ733454A (en) 2023-12-22
RS60575B1 (sr) 2020-08-31
AU2015379642B2 (en) 2021-11-04
HUE050024T2 (hu) 2020-11-30
ES2802982T3 (es) 2021-01-22
DK3250600T3 (da) 2020-06-08
LT3250600T (lt) 2020-07-27
EP3250600B1 (en) 2020-05-06

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