HRP20170548T1 - Anti-fgf23 protutijelo i farmaceutski sastav koji ga sadrži - Google Patents

Anti-fgf23 protutijelo i farmaceutski sastav koji ga sadrži Download PDF

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HRP20170548T1
HRP20170548T1 HRP20170548TT HRP20170548T HRP20170548T1 HR P20170548 T1 HRP20170548 T1 HR P20170548T1 HR P20170548T T HRP20170548T T HR P20170548TT HR P20170548 T HRP20170548 T HR P20170548T HR P20170548 T1 HRP20170548 T1 HR P20170548T1
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seq
antibody
nucleotide position
amino acid
variable region
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HRP20170548TT
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Yuji Yamazaki
Itaru Urakawa
Hitoshi Yoshida
Yukiko Aono
Takeyoshi Yamashita
Takashi Shimada
Hisashi Hasegawa
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Kyowa Hakko Kirin Co., Ltd.
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Application filed by Kyowa Hakko Kirin Co., Ltd. filed Critical Kyowa Hakko Kirin Co., Ltd.
Publication of HRP20170548T1 publication Critical patent/HRP20170548T1/hr

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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
    • C07K16/244Interleukins [IL]
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
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    • 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
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    • A61P19/00Drugs for skeletal disorders
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    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • 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
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    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
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    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • 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
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
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    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
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    • C07ORGANIC CHEMISTRY
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    • 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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Claims (13)

1. Protutijelo na ljudski FGF23 ili funkcionalni fragment navedenog protutijela prema ljudskom FGF23, a) pri čemu protutijelo na ljudski FGF23 ili na funkcionalni fragment navedenog protutijela obuhvaća varijabilnu regiju teškog lanca koja ima komplementarnu determinirajuću regiju (CDR) 1 prikazanu aminokiselinskim slijedom SEQ ID NO:40, CDR2 prikazanu aminokiselinskim slijedom SEQ ID NO:41 i CDR3 prikazanu aminokiselinskim slijedom SEQ ID NO:42 i varijabilnu regiju lakog lanca koja ima komplementarnu determinirajuću regiju (CDR) 1 prikazanu aminokiselinskim slijedom SEQ ID NO:43, CDR2 prikazanu aminokiselinskim slijedom SEQ ID NO:44 i CDR3 prikazanu aminokiselinskim slijedom SEQ ID NO:45, ili
2. pri čemu je protutijelo na ljudski FGF23 proizvedeno od hibridome FERM BP-10772, ili
3. protutijelo ili fragment koje obuhvaća isti slijed aminokiselina kao varijabilna regija teškog lanca i varijabilna regija lakog lanca protutijela proizvedenog od hibridome FERM BP-10772. 2. Funkcionalni fragment iz patentnog zahtjeva 1, pri čemu je navedeni funkcionalni fragment fragment peptida izabran iz grupe koja se sastoji od Fab, Fab', F(ab')2, disulfidom stabilizirane Fv (dsFv), dimerizirane V regije (dijatijelo), jednolančanog Fv (scFv) i CDR. 3. Protutijelo na ljudski FGF23 ili funkcionalni fragment navedenog protutijela iz patentnog zahtjeva 1 ili 2, obuhvaća teški lanac ili laki lanac koji ima aminokiselinski slijed u kojem je obrisana, zamijenjena ili dodana jedna ili nekoliko aminokiselina.
4. Protutijelo na ljudski FGF23 iz bilo kojeg od prethodnih patentnih zahtjeva, pri čemu je razred protutijela izabran iz grupe koja se sastoji od IgG, IgA, IgE i IgM.
5. Protutijelo na ljudski FGF23 iz bilo kojeg od prethodnih patentnih zahtjeva, pri čemu je podrazred IgG protutijela odabran iz grupe koja se sastoji od IgG1, IgG2, IgG3 i IgG4.
6. Farmaceutski sastav, kao aktivni sastojak sadrži protutijelo na ljudski FGF23 ili funkcionalni fragment navedenog protutijela iz bilo kojeg od patentnih zahtjeva 1-5.
7. Farmaceutski sastav za uporabu u motodi sprječavanja ili liječenja bolesti koja je povezana s poremećajima metabolizma minerala, navedeni sastav kao aktivni sastojak sadrži protutijelo na ljudski FGF23 ili funkcionalni fragment navedenog protutijela iz bilo kojeg od patentnih zahtjeva 1-5, pri čemu je bolest koja je povezana s poremećajima metabolizma minerala odabrana iz grupe koja se sastoji od neoplastične osteomalacije, ADHR, XLH, fibrozne displazije, sindroma McCune-Albright i autosomne recesivne hipofosfatemije.
8. Farmaceutski sastav za uporabu u metodi sprječavanja ili liječenja bolesti odabrane iz grupe koja se sastoji od osteoporoze, rahitisa, hiperkalcemije, hipokalcemije, heterotrofne kalcifikacije, osteoskleroze, Pagetove bolesti, hiperparatireoidizma, hipoparatireoidizma i pruritusa, navedeni sastav kao aktivni sastojak sadrži protutijelo na ljudski FGF23 ili funkcionalni fragment navedenog protutijela iz bilo kojeg od patentnih zahtjeva 1-5.
9. Hibridoma pohranjena s pristupnim brojem FERM BP-10772.
10. Nukleinska kiselina koja kodira varijabilnu regiju teškog lanca i varijabilnu regiju lakog lanca obuhvaća slijed od nukleotida na poziciji 58 iz SEQ ID NO:11 do nukleotida na poziciji 408 iz SEQ ID NO:11 i slijed od nukleotida na poziciji 67 iz SEQ ID NO:13 do nukleotida na poziciji 384 iz SEQ ID NO:13.
11. Vektor koji sadrži nukleinsku kiselinu iz patentnog zahtjeva 10.
12. Stanica domaćin koja sadrži vektor iz patentnog zahtjeva 11.
13. Metoda za proizvodnju protutijela na ljudski FGF23 ili funkcionalni fragment navedenog protutijela, obuhvaća korak kultiviranje stanice domaćina, a) stanica domaćin sadrži nukleinsku kiselinu koja kodira aminokiselinski slijed varijabilne regije teškog lanca kodirane slijedom nukleotida od nukleotida na poziciji 58 iz SEQ ID NO:11 do nukleotida na poziciji 408 iz SEQ ID NO:11 i nukleinsku kiselinu koja kodira aminokiselinski slijed varijabilne regije lakog lanca kodirane slijedom nukleotida od nukleotida na poziciji 67 iz SEQ ID NO:13 do nukleotida na poziciji 384 iz SEQ ID NO:13, ili b) stanica domaćin sadrži nukleinsku kiselinu iz patentnog zahtjeva 10, ili c) stanica domaćin sadrži vektor koji sadrži nukleinsku kiselinu koja kodira aminokiselinski slijed varijabilne regije teškog lanca kodirane slijedom nukleotida od nukleotida na poziciji 58 iz SEQ ID NO:11 do nukleotida na poziciji 408 iz SEQ ID NO:11 i vektor koji sadrži nukleinsku kiselinu koja kodira aminokiselinski slijed varijabilne regije lakog lanca kodirane slijedom nukleotida od nukleotida na poziciji 67 iz SEQ ID NO:13 do nukleotida na poziciji 384 iz SEQ ID NO:13, ili d) stanica domaćin sadrži vektor koji sadrži nukleinsku kiselinu koja kodira aminokiselinski slijed varijabilne regije teškog lanca i varijabilne regije lakog lanca kodirane redom slijedom od nukleotida na poziciji 58 iz SEQ ID NO:11 do nukleotida na poziciji 408 iz SEQ ID NO:11 i slijed od nukleotida na poziciji 67 iz SEQ ID NO:13 do nukleotida na poziciji 384 iz SEQ ID NO:13.
HRP20170548TT 2007-02-14 2017-04-04 Anti-fgf23 protutijelo i farmaceutski sastav koji ga sadrži HRP20170548T1 (hr)

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Application Number Priority Date Filing Date Title
JP2007034018 2007-02-14
EP12170984.4A EP2502996B1 (en) 2007-02-14 2008-02-14 Anti-FGF23 antibody and pharmaceutical composition comprising the same

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HRP20170548TT HRP20170548T1 (hr) 2007-02-14 2017-04-04 Anti-fgf23 protutijelo i farmaceutski sastav koji ga sadrži
HRP20201266TT HRP20201266T1 (hr) 2007-02-14 2020-08-11 Anti fg23 antitijelo i farmaceutski pripravak koji sadrži isto

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US (4) US7883705B2 (hr)
EP (3) EP3181691B1 (hr)
JP (1) JP4800396B2 (hr)
KR (1) KR101462291B1 (hr)
CN (2) CN102702355B (hr)
AU (1) AU2008215346B2 (hr)
CA (1) CA2677782C (hr)
CY (3) CY1118835T1 (hr)
DK (3) DK2502996T3 (hr)
ES (3) ES2530670T3 (hr)
FR (1) FR18C1032I2 (hr)
HK (2) HK1140228A1 (hr)
HR (2) HRP20170548T1 (hr)
HU (3) HUE050517T2 (hr)
LT (3) LT2502996T (hr)
LU (2) LUC00081I2 (hr)
NL (1) NL300945I2 (hr)
NO (1) NO2018025I1 (hr)
PL (3) PL2128253T3 (hr)
PT (3) PT2128253E (hr)
SI (2) SI3181691T1 (hr)
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