HRP20130204T1 - Monoklonalna protutijela koja se vežu na hgm-csf i medicinski sastavi koji ih sadrže - Google Patents

Monoklonalna protutijela koja se vežu na hgm-csf i medicinski sastavi koji ih sadrže Download PDF

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HRP20130204T1
HRP20130204T1 HRP20130204AT HRP20130204T HRP20130204T1 HR P20130204 T1 HRP20130204 T1 HR P20130204T1 HR P20130204A T HRP20130204A T HR P20130204AT HR P20130204 T HRP20130204 T HR P20130204T HR P20130204 T1 HRP20130204 T1 HR P20130204T1
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sequence
antigen
antibody
seq
binding fragment
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HRP20130204AT
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Kenzo Takada
Kantou Nakajima
Barbara Kistler
John Park
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Evec Inc.
Boehringer Ingelheim International Gmbh
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Publication of HRP20130204T1 publication Critical patent/HRP20130204T1/hr

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    • C07ORGANIC CHEMISTRY
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    • 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
    • C07K16/243Colony Stimulating Factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • 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
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • 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
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • 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
    • A61P37/08Antiallergic agents
    • 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
    • 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
    • A61K2039/507Comprising a combination of two or more separate antibodies
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    • 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
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Claims (24)

1. Izolirano anti-hGM-CSF monoklonalno protutijelo ili njegov fragment koji se veže na antigen, naznačen(o) time, da spomenuto protutijelo ili njegov fragment koji se veže na antigen, obuhvaća: (a) jaki lanac koji uključuje sekvencu koja sadrži VH-CDR1, sekvencu koja sadrži VH-CDR2 i sekvencu koja sadrži VH-CDR3, pri čemu: (i) sekvenca koja sadrži VH-CDR1 je SYGMH (SEQ ID NO: 4), (ii) sekvenca koja sadrži VH-CDR2 je LTYHHGNRKFYADSVRG (SEQ ID NO: 5) i (iii) sekvenca koja sadrži VH-CDR3 je ESMGAINDN (SEQ ID NO: 6); i (b) slabi lanac koji uključuje sekvencu koja sadrži VL-CDR1, sekvencu koja sadrži VL-CDR2 i sekvencu koja sadrži VL-CDR3, pri čemu: (i) sekvenca koja sadrži VL-CDR1 je IGNNNNIGSHAVG (SEQ ID NO: 7), (ii) sekvenca koja sadrži VL-CDR2 je GRSPPS (SEQ ID NO: 8) i (iii) sekvenca koja sadrži VL-CDR3 je STWDSSLSAVV (SEQ ID NO: 9).
2. Protutijelo ili njegov fragment koji se veže na antigen prema zahtjevu 1, naznačen(o) time, da se protutijelo ili njegov fragment koji se veže na antigen, povezuje na humani GM-CSF s jednim KD manjim od 400 pM.
3. Protutijelo ili njegov fragment koji se veže na antigen prema zahtjevu 1, naznačen(o) time, da protutijelo ili njegov fragment koji se veže na antigen neutralizira djelovanje od hGM-CSF, tako da protutijelo ili njegov fragment koji veže antigen ima IC50-vrijednost manju od 100 pM, kao što je utvrđeno prema ispitivanju proliferacije TF-1 na ED80.
4. Protutijelo ili njegov fragment koji se veže na antigen prema zahtjevu 1 ili 2, naznačen(o) time, da je jaki lanac odabran iz skupine koja se sastoji od gama 1 (γ1), gama 2 (γ2), gama 3 (γ3) i gama 4 (γ4).
5. Protutijelo ili njegov fragment koji se veže na antigen prema zahtjevu 4, naznačen(o) time, da jaki lanac je gama 1 (γ1).
6. Protutijelo ili njegov fragment koji se veže na antigen prema zahtjevu 4 ili 5, naznačen(o) time, da slabi lanac je lambda slabi lanac.
7. Protutijelo ili njegov fragment koji se veže na antigen prema jednom od zahtjeva 1 do 6, naznačen(o) time, da jaki lanac ima jednu amino kiselinsku sekvencu od SEQ ID NO:46 ili od SEQ ID NO: 51.
8. Protutijelo ili njegov fragment koji se veže na antigen prema zahtjevu 7, naznačen(o) time, da jaki lanac ima jednu amino kiselinsku sekvencu od SEQ ID NO:51.
9. Protutijelo ili njegov fragment koji se veže na antigen prema jednom od zahtjeva 1 do 8, naznačen(o) time, da slabi lanac ima jednu amino kiselinsku sekvencu od SEQ ID NO: 36.
10. Protutijelo ili njegov fragment koji se veže na antigen prema jednom od zahtjeva 1 do 6, naznačen(o) time, da sekvenca od varijabilnog područja jakog lanca je SEQ ID NO: 348 ili je SEQ ID NO: 361, i pri čemu sekvenca varijabilnog područja slabog lanca je SEQ ID NO: 365.
11. Protutijelo ili njegov fragment koji se veže na antigen prema zahtjevu 10, naznačen(o) time, da sekvenca od varijabilnog područja jakog lanca je SEQ ID NO: 361.
12. Protutijelo ili njegov fragment koji se veže na antigen prema jednom od zahtjeva 1 do 6, naznačen(o) time, da sekvenca jakog lanca je SEQ ID NO: 46 ili je SEQ ID NO: 51, i pri čemu sekvenca slabog lanca je SEQ ID NO: 36.
13. Protutijelo ili njegov fragment koji se veže na antigen prema zahtjevu 12, naznačen(o) time, da sekvenca jakog lanca je SEQ ID NO: 51.
14. Farmaceutski sastav, naznačen time, da obuhvaća protutijelo ili njegov fragment koji se veže na antigen, prema bilo kojem od zahtjeva 1 do 13, i farmaceutski prihvatljiv nosač.
15. Garnitura, naznačena time, da obuhvaća: (a) protutijelo ili njegov fragment koji se veže na antigen, prema bilo kojem od zahtjeva 1 do 13, i (b) jedan ili više spremnika koji sadrže protutijelo ili njegov fragment koji se veže na antigen.
16. Izolirana nukleinska kiselina, naznačena time, da ona kodira za anti-hGM-CSF monoklonalno protutijelo ili njegov fragment koji se veže na antigen, prema bilo kojem od zahtjeva 1 do 13.
17. Izolirana nukleinska kiselina, naznačena time, da nukleinska kiselina je DNK.
18. Vektor, naznačen time, da on obuhvaća DNK prema zahtjevu 17.
19. Stanica domaćina, naznačena time, da uključuje vektor prema zahtjevu 18, pri čemu taj vektor je vektor ekspresije.
20. Protutijelo ili njegov fragment koji se veže na antigen prema jednom od zahtjeva 1 do 13, ili farmaceutski sastav prema zahtjevu 14, naznačen(o) time, da se upotrebljava kao lijek.
21. Protutijelo ili njegov fragment koji se veže na antigen prema jednom od zahtjeva 1 do 13, ili farmaceutski sastav prema zahtjevu 14, naznačen(o) time, da se upotrebljava za liječenje subjekta od bolesti ili poremećaja koji(a) je povezan(a) s prekomjernom ekspresijom hGM-CSF.
22. Protutijelo ili njegov fragment koji se veže na antigen prema zahtjevu 21, naznačen(o) time, da se kod subjekta primjenjuje određena doza protutijela ili njegovog fragmenta koji se veže na antigen, koja ne premašuje 500 mg.
23. Protutijelo ili njegov fragment koji se veže na antigen prema zahtjevu 21 ili 22, naznačen(o) time, da je bolest ili poremećaj odabran(a) iz skupine koju čine: kronična opstrukcijska plućna bolest (COPD), astma, bronhijalna astma, pedijatrijska astma, teška astma, akutni astmatični napadaji, cistična fibroza, intersticijalna plućna bolest, rinitis, artritis i s njime povezane artropatije, reumatoidni artritis, psorijaza, mijeloidna leukemija i multipla skleroza.
24. Postupak za proizvodnju anti-hGM-CSF monoklonalnog protutijela prema zahtjevu 1 ili njegovog fragmenta koji se veže na antigen prema zahtjevu 1, te koji se veže na hGM-CSF, gdje protutijelo ili njegov fragment koji se veže na antigen obuhvaća najmanje jednu sekvencu koja sadrži VH-CDR1, jednu sekvencu koja sadrži VH-CDR2, jednu skevencu koja sadrži VH-CDR3, jednu sekvencu koja sadrži VL-CDR1, jednu sekvencu koja sadrži VL-CDR2 i jednu sekvencu koja sadrži VL-CDR3, u stanici domaćina, naznačen time, da postupak uključuje: (i) dobivanje stanice domaćina koja obuhvaća najmanje jednu DNK sekvencu koja kodira barem za sekvencu koja sadrži VH-CDR1, sekvencu koja sadrži VH-CDR2, sekvencu koja sadrži VH-CDR3, sekvencu koja sadrži VL-CDR1, sekvencu koja sadrži VL-CDR2 te za sekvencu koja sadrži VL-CDR3, gdje: (a) sekvenca koja sadrži VH-CDR1 je SYGMH (SEQ ID NO: 4), (b) sekvenca koja sadrži VH-CDR2 je LTYHHGNRKFYADSVRG (SEQ ID NO: 5), (c) sekvenca koja sadrži VH-CDR3 je ESMGAINDN (SEQ ID NO: 6), (d) sekvenca koja sadrži VL-CDR1 je IGNNNNIGSHAVG (SEQ ID NO: 7), (e) sekvenca koja sadrži VL-CDR2 je GRSPPS (SEQ ID NO: 8) i (f) sekvenca koja sadrži VL-CDR3 je STWDSSLSAVV (SEQ ID NO: 9); te (ii) kultiviranje stanice domaćina pod prikladnim uvjetima za ekspresiju DNK i za proizvodnju protutijela ili njegovog fragmenta koji se veže na antigen.
HRP20130204AT 2007-11-13 2013-03-08 Monoklonalna protutijela koja se vežu na hgm-csf i medicinski sastavi koji ih sadrže HRP20130204T1 (hr)

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JP2007294945 2007-11-13
JP2008052471 2008-02-14
PCT/US2008/012680 WO2009064399A1 (en) 2007-11-13 2008-11-12 Monoclonal antibodies that bind to hgm-csf and medical compositions comprising same

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US (2) US8679502B2 (hr)
EP (3) EP2559706A1 (hr)
KR (1) KR20100102108A (hr)
CN (2) CN101970489B (hr)
AR (1) AR069290A1 (hr)
AU (1) AU2008321429A1 (hr)
BR (1) BRPI0820530A2 (hr)
CA (1) CA2705539A1 (hr)
CL (1) CL2008003361A1 (hr)
CO (1) CO6382188A2 (hr)
DK (1) DK2215119T3 (hr)
EC (1) ECSP10010251A (hr)
ES (1) ES2401536T3 (hr)
HK (1) HK1146729A1 (hr)
HR (1) HRP20130204T1 (hr)
IL (1) IL205576A0 (hr)
MA (1) MA31899B1 (hr)
ME (1) ME01005B (hr)
MX (1) MX2010005291A (hr)
NZ (2) NZ586027A (hr)
PE (1) PE20091420A1 (hr)
PL (1) PL2215119T3 (hr)
PT (1) PT2215119E (hr)
RS (1) RS52713B (hr)
RU (2) RU2517596C2 (hr)
SG (1) SG176499A1 (hr)
SI (1) SI2215119T1 (hr)
TN (1) TN2010000210A1 (hr)
TW (2) TW201206955A (hr)
UY (1) UY31466A1 (hr)
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