HRP20171499T1 - Protutijela za humani gdf8 - Google Patents

Protutijela za humani gdf8 Download PDF

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Publication number
HRP20171499T1
HRP20171499T1 HRP20171499TT HRP20171499T HRP20171499T1 HR P20171499 T1 HRP20171499 T1 HR P20171499T1 HR P20171499T T HRP20171499T T HR P20171499TT HR P20171499 T HRP20171499 T HR P20171499T HR P20171499 T1 HRP20171499 T1 HR P20171499T1
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Croatia
Prior art keywords
antigen
binding fragment
antibody
seq
amino acid
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HRP20171499TT
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English (en)
Inventor
Trevor Stitt
Esther Latres
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Regeneron Pharmaceuticals, Inc.
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=44477626&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20171499(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Regeneron Pharmaceuticals, Inc. filed Critical Regeneron Pharmaceuticals, Inc.
Publication of HRP20171499T1 publication Critical patent/HRP20171499T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • 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
    • 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/06Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
    • A61K49/08Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by the carrier
    • A61K49/10Organic compounds
    • A61K49/14Peptides, e.g. proteins
    • A61K49/16Antibodies; Immunoglobulins; Fragments thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • 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
    • 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
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/04Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • 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
    • A61P21/06Anabolic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • C07K2317/56Immunoglobulins 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567Framework region [FR]
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Claims (10)

1. Izolirano humano protutijelo ili njegov fragment koji se veže na antigen, naznačen time, da se specifično veže na ili blokira biološku aktivnost divljeg tipa zrelog humanog GDF8 koji sadržava SEQ ID NO: 340, ali se ne veže na ili blokira biološku aktivnost himernog GDFB/TGF01 konstrukta koji sadržava aminokiseline 4872 zrelog humanog GDF8 zamijenjene odgovarajućom aminokiselinskom sekvencom TGFpi, pri čemu himerni GDF8/TGF01 konstrukt sadržava aminokiselinsku sekvencu SEQ ID NO: 352, i pri čemu protutijelo ili fragment koji veže antigen sadržava: (a) HCDR1 / HCDR2 / HCDR3 aminokiselinske sekvence koje se sastoje od SEQ ID NO: 362/364/366, i
2. sekvence aminokiselina LCDR1 / LCDR2 / LCDR3 koje se sastoje od SEQ ID NO: 370/372/374. 2. Izolirano protutijelo ili fragment koji se veže na antigen u skladu s patentnim zahtjevom 1, naznačen time, da protutijelo ili fragment koji veže antigen sadržava: (a) CDR-ove teškog lanca (HCDR1, HCDR2 i HCDR3) iz varijabilne regije teškog lanca koja sadržava aminokiselinsku sekvencu odabranu iz skupine koju čine SEQ ID NO: 360 i (b) CDR-ove lakog lanca (LCDR1, LCDR2 i LCDR3) iz varijabilne regije lakog lanca koja sadržava sekvencu aminokiselina koja se sastoji od SEQ ID NO: 368.
3. Izolirano protutijelo ili fragment koji se veže na antigen u skladu s patentnim zahtjevom 1 ili 2, naznačen time, da protutijelo ili fragment koji se veže na antigen ne vežu na (a) linearni epitop unutar divljeg tipa zrelog GDF8 (SEQ ID NO: 340); i / ili (b) izolirane GDF8 peptide koji sadržavaju aminokiselinske sekvence aminokiselina 114, 1-18, 17-42, 48-65, 48-69, 48-72, 52-65, 52-72, 56-65, 56-72, 65-72, 73-90, 75-105 i 91-105 od SEQ ID NO: 340.
4. Farmaceutski pripravak, naznačen time, da sadržava protutijelo ili fragment koji se veže na antigen u skladu s bilo kojim od patentnih zahtjeva 1 do 3 i farmaceutski prihvatljivi nosač ili razrjeđivač.
5. Izolirano protutijelo ili fragment koji se veže na antigen u skladu s bilo kojim od patentnih zahtjeva 1 do 3, ili farmaceutski pripravak u skladu s patentnim zahtjevom 4, naznačen time, da se upotrebljava u medicini.
6. Izolirano protutijelo ili fragment koji se veže na antigen u skladu s bilo kojim od patentnih zahtjeva 1 do 3, ili farmaceutski pripravak u skladu s patentnim zahtjevom 4, naznačen time, da se upotrebljava u liječenju pacijenta koji pati od, dijagnosticirana mu je ili je izložen riziku od bolesti ili poremećaja odabranih iz skupine koja se sastoji od sarkopenije, kaheksije i atrofije mišića zbog neaktivnosti ili imobilizacije.
7. Upotreba izoliranog protutijela ili fragmenta koji se veže na antigen u skladu s bilo kojim od patentnih zahtjeva 1 do 3, ili farmaceutski pripravak u skladu s patentnim zahtjevom 4, naznačen time, da se koristi u proizvodnji lijeka za uporabu u liječenju pacijenta koji pati od, dijagnosticirana mu je ili je izložen riziku od bolesti ili poremećaja odabranog iz skupine koja se sastoji od sarkopenije, kaheksije, gubitka mišića, atrofije mišića, raka, artritisa, multiple skleroze, amiotrofne lateralne skleroze, Parkinsonove bolesti, osteoporoze, osteoartritisa, osteopenije, frakture kostiju, uključujući frakture kuka, metaboličkih sindroma, homeostaze glukoze i osjetljivosti na inzulin.
8. Uporaba u skladu s patentnim zahtjevom 7, naznačena time, da je kaheksija idiopatska ili sekundarna u odnosu na druge uvjete.
9. Uporaba u skladu s patentnim zahtjevom 7, naznačena time, da je gubitak mišića ili atrofija uzrokovana ili povezana s neupotrebom mišića, imobilizacijom, ležajem, ozljedom, medicinskim tretmanom ili kirurškim zahvatom.
10. Upotreba u skladu s patentnim zahtjevom 7, naznačena time, da je metabolički sindrom odabran iz skupine koju čine dijabetes, pretilost, prehrambeni poremećaji, atrofija organa, kronična opstruktivna plućna bolest i anoreksija.
HRP20171499TT 2010-05-26 2017-10-05 Protutijela za humani gdf8 HRP20171499T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US34855910P 2010-05-26 2010-05-26
US37288210P 2010-08-12 2010-08-12
PCT/US2011/037837 WO2011150008A1 (en) 2010-05-26 2011-05-25 Antibodies to human gdf8
EP11726005.9A EP2576618B1 (en) 2010-05-26 2011-05-25 Antibodies to human gdf8

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HRP20171499T1 true HRP20171499T1 (hr) 2017-11-17

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US (5) US8840894B2 (hr)
EP (1) EP2576618B1 (hr)
JP (1) JP5896993B2 (hr)
KR (1) KR101859911B1 (hr)
CN (1) CN102933602B (hr)
AR (1) AR081221A1 (hr)
AU (1) AU2011258342B2 (hr)
BR (1) BR112012029986B1 (hr)
CA (1) CA2800581C (hr)
CL (1) CL2012003283A1 (hr)
CO (1) CO6620013A2 (hr)
CR (1) CR20120577A (hr)
CY (1) CY1119445T1 (hr)
DK (1) DK2576618T3 (hr)
DO (1) DOP2012000295A (hr)
EC (1) ECSP12012309A (hr)
ES (1) ES2647389T3 (hr)
GT (1) GT201200318A (hr)
HR (1) HRP20171499T1 (hr)
HU (1) HUE037140T2 (hr)
IL (1) IL223003A (hr)
JO (1) JO3340B1 (hr)
LT (1) LT2576618T (hr)
MX (2) MX2012013369A (hr)
MY (1) MY157109A (hr)
NI (1) NI201200171A (hr)
NO (1) NO2576618T3 (hr)
NZ (1) NZ603529A (hr)
PE (1) PE20130226A1 (hr)
PL (1) PL2576618T3 (hr)
PT (1) PT2576618T (hr)
RS (1) RS56368B1 (hr)
RU (2) RU2567805C2 (hr)
SG (2) SG10201504092TA (hr)
SI (1) SI2576618T1 (hr)
TN (1) TN2012000555A1 (hr)
TW (2) TWI602917B (hr)
UY (1) UY33407A (hr)
WO (1) WO2011150008A1 (hr)
ZA (1) ZA201208525B (hr)

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