HRP20181939T4 - Postupci za liječenje osteogenesis imperfecta - Google Patents

Postupci za liječenje osteogenesis imperfecta Download PDF

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Publication number
HRP20181939T4
HRP20181939T4 HRP20181939TT HRP20181939T HRP20181939T4 HR P20181939 T4 HRP20181939 T4 HR P20181939T4 HR P20181939T T HRP20181939T T HR P20181939TT HR P20181939 T HRP20181939 T HR P20181939T HR P20181939 T4 HRP20181939 T4 HR P20181939T4
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antibody
antigen
binding fragment
use according
seq
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HRP20181939TT
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Brendan Lee
Kuber T. Sampath
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Genzyme Corporation
Baylor College Of Medicine
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Application filed by Genzyme Corporation, Baylor College Of Medicine filed Critical Genzyme Corporation
Publication of HRP20181939T1 publication Critical patent/HRP20181939T1/hr
Publication of HRP20181939T4 publication Critical patent/HRP20181939T4/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/42Phosphorus; Compounds thereof
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • 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
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/16Otologicals
    • 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
    • C07K16/22Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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
    • C07K2317/52Constant or Fc region; Isotype
    • 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
    • C07K2317/50Immunoglobulins 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

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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)
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  • Proteomics, Peptides & Aminoacids (AREA)
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  • Endocrinology (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Pulmonology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Compounds Of Unknown Constitution (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (20)

1. Protutijelo ili njegov ulomak koji veže antigen koji se specifično veže na i neutralizira ljudski TGFβ1, TGFβ2, i TGFβ3 za uporabu za liječenje osteogenesis imperfecta (OI) kod subjekta kojem je to potrebno naznačeno time što protutijelo ili njegov ulomak koji veže antigen obuhvaća varijabilnu regiju teškog lanca koja sadrži tri regije koje određuju komplementarnost (CDR) koje sadrže aminokiselinske sekvence SEQ ID NOs: 4, 5, i 6; i varijabilnu regiju lakog lanca koja sadrži tri CDR koje sadrže aminokiselinske sekvence SEQ ID NOs: 7, 8, i 9.
2. Protutijelo ili njegov ulomak koji veže antigen za upotrebu prema zahtjevu 1, naznačeno time što antitijelo ili njegov ulomak koji veže antigen sadrži varijabilnu regiju teškog lanca koja sadrži aminokiselinsku sekvencu SEQ ID NO: 10 i varijabilnu regiju lakog lanca koja sadrži aminokiselinska sekvencu SEQ ID NO: 11.
3. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema zahtjevu 1 ili 2, naznačeno time što protutijelo ili njegov ulomak koji veže antigen dalje sadrži ljudsku IgG4 konstantnu regiju.
4. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema zahtjevu 3, naznačeno time što ljudska IgG4 konstantna regija sadrži aminokiselinsku sekvencu iz SEQ ID NO: 12.
5. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo ili njegov ulomak koji veže antigen nadalje sadrži ljudsku κ konstantnu regiju lakog lanca.
6. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema zahtjevu 5, naznačeno time što ljudska κ konstantna regija lakog lanca sadrži aminokiselinsku sekvencu iz SEQ ID NO: 13.
7. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od zahtjeva 1 ili zahtjeva 2, naznačeno time što protutijelo ili njegov ulomak koji veže antigen nadalje sadrži ljudsku IgG4 konstantnu regiju, i ljudsku κ konstantnu regiju lakog lanca.
8. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema zahtjevu 7, naznačeno time što ljudska IgG4 konstantna regija sadrži aminokiselinsku sekvencu iz SEQ ID NO: 12, i ljudska κ konstantna regija lakog lanca sadrži aminokiselinsku sekvencu iz SEQ ID NO: 13.
9. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo sadrži teški lanac koji sadrži aminokiselinsku sekvencu iz SEQ ID NO: 14.
10. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo sadrži lagani lanac koji sadrži aminokiselinsku sekvencu iz SEQ ID NO: 15.
11. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo sadrži teški lanac koji sadrži aminokiselinsku sekvencu iz SEQ ID NO: 14, i lagani lanac koji sadrži aminokiselinsku sekvencu iz SEQ ID NO: 15.
12. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo ili njegov ulomak koji veže antigen poboljšava koštani parametar odabran iz skupine koja sadrži gustoću volumena kosti (BV/TV), ukupnu površinu kosti (BS), gustoću površine kosti (BS/BV), broj trabekula (Tb.N), trabekularnu debljinu (Tb.Th), trabekularno razdvajanje (Tb.Sp), i ukupni volumen (Dens TV).
13. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo ili njegov ulomak koji veže antigen inhibira razgradnju kosti.
14. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo ili njegov ulomak koji veže antigen smanjuje biomarker seruma resorpcije kosti odabran iz skupine koju čine urinarni hidroksiprolin, urinarni ukupni piridinolin (PYD), urinarni slobodni deoksipiridinolin (DPD), urinarni N-terminalni križni telopeptid kolagena tip-I (NTX), urinarni ili serumski C-terminalni križni telopeptid kolagena tip-I (CTX), koštani sijaloprotein (BSP), osteopontin (OPN), i kisela fosfataza otporna na tartarat 5b (TRAP).
15. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo ili njegov ulomak koji veže antigen povećava biomarker seruma odlaganja kosti odabran iz skupine koju čine ukupna alkalna fosfataza, alkalna fosfataza specifična za kosti, osteokalcin, i prokolagen tip-I (C-terminalni/N-terminalni).
16. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo ili njegov ulomak koji veže antigen potiče odlaganje kostiju.
17. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo ili njegov ulomak koji veže antigen poboljšava funkciju ne-skeletnog organa koji je pogođen s OI odabranim iz skupine koja se sastoji od funkcije sluha, funkcije pluća, i funkcije bubrega.
18. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema zahtjevu 1, naznačeno time što se navedeno protutijelo ili njegov ulomak koji veže antigen koristi u kombinaciji s barem jednim terapeutskim sredstvom.
19. Protutijelo ili njegov ulomak koji veže antigen za uporabu prema zahtjevu 18, naznačeno time što je barem jedno terapeutsko sredstvo je odabrano iz skupine koju čine bisfosfonat, paratiroidni hormonski analog koji potiče stvaranje kostiju, kalcitonin, i selektivni modulator receptora estrogena (SERM).
20. Protutijelo ili ulomak koji veže antigen za uporabu prema zahtjevu 18 ili 19, naznačeno time što je barem jedno terapeutsko sredstvo paratiroidni hormonski analog koji potiče stvaranje kostiju.
HRP20181939TT 2013-03-20 2014-03-20 Postupci za liječenje osteogenesis imperfecta HRP20181939T4 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201361803647P 2013-03-20 2013-03-20
US201361875399P 2013-09-09 2013-09-09
US201361883151P 2013-09-26 2013-09-26
EP14717386.8A EP2976359B2 (en) 2013-03-20 2014-03-20 Methods for treating osteogenesis imperfecta
PCT/US2014/031279 WO2014153435A1 (en) 2013-03-20 2014-03-20 Methods for treating osteogenesis imperfecta

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HRP20181939T1 HRP20181939T1 (hr) 2019-01-25
HRP20181939T4 true HRP20181939T4 (hr) 2022-05-13

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HRP20192277TT HRP20192277T1 (hr) 2013-03-20 2019-12-17 Postupci za liječenje osteogenesis imperfecta

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US (4) US9598486B2 (hr)
EP (3) EP2976359B2 (hr)
JP (3) JP6483086B2 (hr)
KR (1) KR102257138B1 (hr)
CN (2) CN111000997A (hr)
AU (1) AU2014235933B2 (hr)
CA (1) CA2907422C (hr)
CL (1) CL2015002801A1 (hr)
DK (2) DK3312195T3 (hr)
EA (1) EA032327B1 (hr)
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HK (2) HK1213576A1 (hr)
HR (2) HRP20181939T4 (hr)
HU (1) HUE046702T2 (hr)
IL (2) IL241461B (hr)
LT (2) LT2976359T (hr)
MX (2) MX369360B (hr)
MY (1) MY172324A (hr)
PH (2) PH12015501864A1 (hr)
PL (2) PL3312195T3 (hr)
PT (2) PT3312195T (hr)
RS (2) RS58188B2 (hr)
SG (2) SG10201701985YA (hr)
SI (2) SI2976359T2 (hr)
TW (1) TWI629995B (hr)
UY (1) UY35493A (hr)
WO (1) WO2014153435A1 (hr)

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KR102257138B1 (ko) 2021-05-26
HRP20192277T1 (hr) 2020-03-06
WO2014153435A1 (en) 2014-09-25
CA2907422A1 (en) 2014-09-25
CN111000997A (zh) 2020-04-14
PL2976359T3 (pl) 2019-03-29
EP2976359B1 (en) 2018-08-29
LT2976359T (lt) 2018-12-27
MX2019009122A (es) 2019-09-16
BR112015023905A2 (pt) 2017-10-24
CN105229028A (zh) 2016-01-06
US20160031979A1 (en) 2016-02-04
PH12015501864B1 (en) 2015-12-07
JP2019089826A (ja) 2019-06-13
NZ712353A (en) 2021-04-30
CN105229028B (zh) 2019-11-08
MY172324A (en) 2019-11-21
IL241461A0 (en) 2015-11-30
PH12019500261B1 (en) 2020-07-20
HRP20181939T1 (hr) 2019-01-25
EA032327B1 (ru) 2019-05-31
AU2014235933B2 (en) 2019-01-24
RS58188B2 (sr) 2022-06-30
IL287915A (en) 2022-01-01
TWI629995B (zh) 2018-07-21
ES2700238T3 (es) 2019-02-14
DK2976359T4 (da) 2022-06-13
DK2976359T3 (da) 2019-01-02
EP3312195B1 (en) 2019-10-09
SI2976359T2 (sl) 2022-05-31
SG10201701985YA (en) 2017-04-27
JP2016519093A (ja) 2016-06-30
PL3312195T3 (pl) 2020-04-30
TW201524515A (zh) 2015-07-01
EA201591843A1 (ru) 2016-01-29
DK3312195T3 (da) 2020-01-06
EP3640260A1 (en) 2020-04-22
KR20150132262A (ko) 2015-11-25
HK1213576A1 (zh) 2016-07-08
IL241461B (en) 2021-12-01
RS58188B1 (sr) 2019-03-29
EP3312195A1 (en) 2018-04-25
PH12015501864A1 (en) 2015-12-07
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JP7016113B2 (ja) 2022-02-04
SI3312195T1 (sl) 2020-02-28
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US20190389943A1 (en) 2019-12-26
EP2976359A1 (en) 2016-01-27
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US11230595B2 (en) 2022-01-25
PT2976359T (pt) 2018-12-05
HK1253717A1 (zh) 2019-06-28
CL2015002801A1 (es) 2016-08-12
UY35493A (es) 2014-11-28
PT3312195T (pt) 2019-12-23
JP6483086B2 (ja) 2019-03-13
RS59673B1 (sr) 2020-01-31
ES2763869T3 (es) 2020-06-01
MX2015013402A (es) 2016-01-08
US9598486B2 (en) 2017-03-21
US20220195025A1 (en) 2022-06-23
PH12019500261A1 (en) 2020-07-20
EP2976359B2 (en) 2022-03-23
JP6677837B2 (ja) 2020-04-08
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HUE046702T2 (hu) 2020-03-30
SI2976359T1 (sl) 2019-03-29
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US20170247439A1 (en) 2017-08-31
AU2014235933A1 (en) 2015-10-01
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PL2976359T5 (pl) 2022-07-18

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