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HRP20170679T1 - Epitopi sklerostina - Google Patents

Epitopi sklerostina Download PDF

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Publication number
HRP20170679T1
HRP20170679T1 HRP20170679TT HRP20170679T HRP20170679T1 HR P20170679 T1 HRP20170679 T1 HR P20170679T1 HR P20170679T T HRP20170679T T HR P20170679TT HR P20170679 T HRP20170679 T HR P20170679T HR P20170679 T1 HRP20170679 T1 HR P20170679T1
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HR
Croatia
Prior art keywords
bone
disease
bone loss
polypeptide
monoclonal antibody
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Application number
HRP20170679TT
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English (en)
Inventor
Hsieng Sen Lu
Christopher Paszty
Martyn Kim Robinson
Alistair James Henry
Kelly Sue Hoffmann
John Latham
Alastair Lawson
David Winkler
Aaron George Winters
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Amgen Inc.
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36956127&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20170679(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc. filed Critical Amgen Inc.
Publication of HRP20170679T1 publication Critical patent/HRP20170679T1/hr
Publication of HRP20170679T4 publication Critical patent/HRP20170679T4/hr

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    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • 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
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475Growth factors; Growth regulators
    • C07K14/51Bone morphogenetic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
    • 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
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • 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
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • 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
    • C07K2317/70Immunoglobulins 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)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Immunology (AREA)
  • Rheumatology (AREA)
  • Toxicology (AREA)
  • Plant Pathology (AREA)
  • Microbiology (AREA)
  • Physics & Mathematics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (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)
  • Table Devices Or Equipment (AREA)

Claims (12)

1. Postupak za proizvodnju polipeptida koji je imunogeni dio humanog sklerostina, naznačen time, da obuhvaća sljedeće korake: a) tretiranja humanog sklerostina radi postizanja potpune triptičke digestije; b) sakupljanja uzorka triptičkog digesta prosječne molekulske mase od 7,122.0 Daltona (teorijska masa 7121.5 Daltona) kako je određeno masenom spektrometrijom elektrosprej ionizacije tekućih kristala ili retencijskim vremenom od oko 20.6 minuta kako je određeno eluiranjem HPLC kolone na reverznim fazama s linearnim gradijentom od 0.05% trifluoroctene kiseline (TFA) do 90% acetonitrila u 0.05% TFA pri brzini protoka od 0.2 ml/min; i c) pročišćavanja imunogenog dijela.
2. Polipeptid, naznačen time, da se može dobiti postupkom iz patentnog zahtjeva 1.
3. Neterapijski postupak stvaranja protutijela, naznačen time, da se sastoji od primjene polipeptida iz patentnog zahtjeva 2 na životinju koja je štakor, hrčak, zec ili miš.
4. Monoklonsko protutijelo koje se veže za polipeptid iz patentnog zahtjeva 2, naznačen time, da se veže za humani sklerostin s disocijacijskom konstantom manjom ili jednakom od 1 x 10-9 M kako je izmjereno površinskom plazmonskom rezonancijom; te povećava barem jednu formaciju kosti, mineralnu gustoću kosti, mineralni sastav kosti, koštanu masu, kvalitetu kosti i jačinu kosti kod sisavca.
5. Monoklonsko protutijelo prema patentnom zahtjevu 4, naznačeno time, da se veže na polipeptide T20, T20.6, T21-22 i N22.7-23.5 te ima minimalno detektabilno vezanje za polipeptide T19.2, N14.6 and N18.6, pri čemu polipeptid T20 ima odsječke DVSEYSCREL HFTRYVTDGP CRSAKPVTEL VCSGQCGPAR i PSGPDFR CIPDRYRAQR VQLLCPGGEA PRARKVRLVA SCKCKRLT R; pri čemu polipeptid T20.6 ima odsječke DVSEYSCREL HFTR, WWRPSGPPFR CIPDRYR, SAKPVTELVC SGQCGPAR i LVASCKCKRL TR; pri čemu polipeptid T21-22 ima odsječke DVSEYSCREL HFTRYVTDGP CRSAKPVTEL VCSGQCGPAR i WWRPSGPDFR CIPDRYRAQR VQLLCPGGEA PRARKVRLVA SCKCKRLTR; pri čemu polipeptid N22.7-23.5 ima odsječke DVSEYSCREL HFTRYVTDGP CRSAKPVTEL VCSGQCGPAR LLPNAIGRGK WWRPSGPDFR CIPDRYRAQR VQLLCPGGEA PRARKVRLVA SCKCKRLTRF HNQS; pri čemu polipeptid T19.2 ima odsječke YVTDGP CR i VQLLCPGGEA PR; pri čemu polipeptid N14.6 ima odsječke ENGGRPPHHPF, EIIPELGFYP EPPP i DFGTEAARPQ KGRKPRPRAR SAKANQA; i pri čemu polipeptid N18.6 ima odsječke DATEIIPELG EYPEPPPELE NNKTMNRAEN GGRPPHHPFE TK.
6. Monoklonsko protutijelo prema bilo kojem od patentnih zahtjeva 4 ili 5, naznačeno time, da je fragment F(ab')2, Fab, Fab' ili Fv.
7. Monoklonsko protutijelo prema bilo kojem od patentnih zahtjeva 4 do 6, naznačeno time, daje humanizirano protutijelo ili humano protutijelo.
8. Monoklonsko protutijelo prema bilo kojem od patentnih zahtjeva 4 do 7, naznačeno time, da se veže za humani sklerostin s disocijacijskom konstantom manjom od ili jednakom 1 x 10-10 M, manjom od ili jednakom 1 x 10~11 M ili koja je manja od ili jednaka 1 x 10-12 M.
9. Monoklonsko protutijelo prema bilo kojem od patentnih zahtjeva 4 do 8, naznačeno time, da se veže za humani sklerostin s afinitetom, kako je izmjereno površinskom plazmonskom rezonancijom, koja je najmanje 50, 100, 250, 500, 1000 ili 10,000 puta veća od afiniteta za lizozim kokošjeg bjelanjka.
10. Monoklonsko protutijelo prema bilo kojem od patentnih zahtjeva 4 do 9, naznačeno time, da je za uporabu u liječenju osteoporoze ili osteopenije.
11. Monoklonsko protutijelo prema bilo kojem od patentnih zahtjeva 4 do 9, naznačen time, da se koristi u postupku liječenja osteopenije, osteoporoze ili gubitka kosti usljed ahondroplazije, kleidokranijalne disostoze, enhondromatoze, fibrozne displazije, Gaucherove bolesti, hipofosfatemičnog rahitisa, Marfanovog sindroma, višestruke nasljedne egzotoze, neurofibromatoze, nesavršene osteogeneze, osteopoikilozisa, sklerotične lezije, pseudoartroze, piogenog osteomijelitisa, bolesti periodonta, gubitka kosti kao posljedica uzimanja protu-epileptičkog lijeka, primarne i sekundarne hiperparatiroidoze, obiteljskih sindroma hiperparatiroidoze, gubitka kosti usljed bestežinskog stanja, osteoporoze u muškaraca, gubitka kosti nakon menopauze, osteoartritisa, bubrežne osteodistrofije, infiltracijskog poremećaja kosti, gubitak oralne kosti, osteonekroze čeljusti, juvenilne Pagetove bolesti, meloreostoze, metaboličke bolesti kostiju, mastocitoze, srpaste anemije/bolesti, gubitka kosti povezane s usadkom, gubitak kosti povezane s usadkom bubrega, sistemskog lupusa eritematozusa, ankiloznog spondilitisa, epilepsije, juvenilnog artritisa, talasemije, mukopolisaharidoze, Fabrijeve bolesti, Turnerovog sindroma, Dovvnovog sindroma, Klinefelterovog sindroma, lepre, Perthesove bolesti, adolescentske idiopatske skolioze, početne infantilne više-sustavne upalne bolesti, Winchesterovog sindroma, Menkesove bolesti, Wilsonove bolesti, ishemične koštane bolesti (poput Legg-Calve-Perthesove bolesti, regionalne migratome osteoporoze), anemičnih stanja, stanja uzrokovanih steroidima, gubitka kosti izazvane glukokortikoidima, gubitka kosti izazvane heparinom, poremećaja koštane srži, skorbuta, pothranjenosti, nedostatka kalcija, idiopatske osteopenije ili osteoporze, kongenitalne osteopenije ili osteoporoze, alkoholizma, kroničnog oboljenja jetara, stanja poslije menopauze, kroničnih upalnih stanja, reumatoidinog artritisa, upalne bolesti crijeva, ulceroznog kolitisa, upalnog kolitisa, Crohnove bolesti, oligomenoreje, amenoreje, trudnoće, dijabetes melitusa, hipertiroidizma, poremećaja štitnjače, paratiroidnih poremećaja, Cushingove bolesti, akromegalije, hipogonadizma, imobilizacije ili neuporabe, sindroma refleksne simpatetičke distrofije, regionalne osteoporoze, osteomalacije, gubitka kosti usljed zamjene zgloba, gubitka kosti povezane s HIV-om, gubitka kosti povezane s hormonom rasta, gubitka kosti povezane s cističnom fibrozom, fibroznom displazijom, gubitka kosti povezane s kemoterapijom, gubitka kosti izazvane tumorom, gubitkom kosti povezane s karcinomom, gubitka kosti zbog ablativne hormonske terapije, višestrukog mijeloma, gubitka kosti izazvane uzimanjem lijekova, anoreksija nervoza, gubitka kostiju lica usljed bolesti, gubitka kranijalne kosti usljed bolesti, gubitka čeljusne kosti usljed bolesti, gubitka kosti lubanje usljed bolesti ili gubitka kosti usljed putovanja u svemir.
12. Monoklonsko protutijelo prema bilo koje od patentnih zahtjeva 4 -9, naznačeno time, da je za uporabu u poboljšavanju ishoda kod ortopedskih procedura, zubnih procedura, operacija usadka, zamjene zglobova, presađivanja kosti, kozmetičke operacije kosti ili reparacije poput liječenja loma, zacjeljivanja bez srastanja, zakašnjelog zacjeljivanja ili rekonstrukcije lica.
HRP20170679TT 2005-05-03 2006-04-28 Epitopi sklerostina HRP20170679T4 (hr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US67758305P 2005-05-03 2005-05-03
US77684706P 2006-02-24 2006-02-24
US78224406P 2006-03-13 2006-03-13
US79264506P 2006-04-17 2006-04-17
US11/410,540 US8003108B2 (en) 2005-05-03 2006-04-25 Sclerostin epitopes
EP10014373.4A EP2301961B9 (en) 2005-05-03 2006-04-28 Sclerostin epitopes

Publications (2)

Publication Number Publication Date
HRP20170679T1 true HRP20170679T1 (hr) 2017-07-14
HRP20170679T4 HRP20170679T4 (hr) 2023-10-13

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ID=36956127

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20170514TT HRP20170514T4 (hr) 2005-05-03 2006-04-28 Epitopi sklerostina
HRP20170679TT HRP20170679T4 (hr) 2005-05-03 2006-04-28 Epitopi sklerostina

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HRP20170514TT HRP20170514T4 (hr) 2005-05-03 2006-04-28 Epitopi sklerostina

Country Status (17)

Country Link
US (3) US8003108B2 (hr)
EP (6) EP2301961B9 (hr)
JP (7) JP5680823B2 (hr)
CA (1) CA2607276C (hr)
CY (2) CY1118977T1 (hr)
DK (2) DK2301961T4 (hr)
ES (5) ES2624643T5 (hr)
FI (2) FI2301961T4 (hr)
HR (2) HRP20170514T4 (hr)
HU (2) HUE033718T2 (hr)
LT (2) LT2301961T (hr)
MX (1) MX348432B (hr)
MY (1) MY174493A (hr)
PL (2) PL2251351T5 (hr)
PT (2) PT2251351T (hr)
SI (2) SI2301961T2 (hr)
WO (1) WO2006119062A2 (hr)

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