HRP20201729T1 - Antitijela protiv aktivina a i njihova primjena - Google Patents

Antitijela protiv aktivina a i njihova primjena Download PDF

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Publication number
HRP20201729T1
HRP20201729T1 HRP20201729TT HRP20201729T HRP20201729T1 HR P20201729 T1 HRP20201729 T1 HR P20201729T1 HR P20201729T T HRP20201729T T HR P20201729TT HR P20201729 T HRP20201729 T HR P20201729T HR P20201729 T1 HRP20201729 T1 HR P20201729T1
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HR
Croatia
Prior art keywords
antigen
antibody
binding fragment
gdf8
amino acid
Prior art date
Application number
HRP20201729TT
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English (en)
Inventor
Jesper Gromada
Esther Latres
Andrew J. Murphy
George D. Yancopoulos
Lori C. Morton
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Regeneron Pharmaceuticals, Inc.
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Publication date
Application filed by Regeneron Pharmaceuticals, Inc. filed Critical Regeneron Pharmaceuticals, Inc.
Publication of HRP20201729T1 publication Critical patent/HRP20201729T1/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
    • 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
    • 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
    • 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
    • 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
    • A61P21/02Muscle relaxants, e.g. for tetanus or cramps
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • 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
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Rheumatology (AREA)
  • Neurosurgery (AREA)
  • Obesity (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Pain & Pain Management (AREA)
  • Psychology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Emergency Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Claims (5)

1. Izolirano antitijelo ili njegov fragment koji se vezuje za antigen koje se specifično vezuje za aktivin A s konstantom ravnoteže disocijacije vezivanja (KD) manjom od 5 pM, opcionalno s KD-om manjom od 4 pM, izmjereno testom rezonancije površinskih plazmona pri temperaturi od 25 °C, naznačeno time, što antitijelo ili fragment koji se vezuje za antigen obuhvaća: HCDR1-HCDR2-HCDR3-LCDR1-LCDR2-LCDR3 domene koje imaju aminokiselinske sekvence SEQ ID NO: 164-166-168-148-150-152.
2. Izolirano antitijelo ili njegov fragment koji se vezuje za antigen prema patentnom zahtjevu 1, naznačeno time, što antitijelo ili fragment koji se vezuje za antigen uključuje: (a) HCVR koji ima aminokiselinsku sekvencu SEQ ID NO: 162; i (b) LCVR koji ima aminokiselinsku sekvencu SEQ ID NO: 146.
3. Farmaceutski pripravak koji obuhvaća antitijelo ili fragment koji se vezuje za antigen prema patentnom zahtjevu 1 ili patentnom zahtjevu 2 i farmaceutski prihvatljivi nosač ili razrjeđivač.
4. Farmaceutski pripravak prema patentnom zahtjevu 3, koji dodatno obuhvaća antagonist GDF8, opcionalno naznačen time, što je antagonist GDF8 odabran iz skupine koja se sastoji od fuzijskog proteina koji inhibira GDF8, anti-GDF8 antitijela i fragmenta anti-GDF8 antitijela koji se vezuje za antigen.
5. Antitijelo ili njegov fragment koji se vezuje za antigen prema patentnom zahtjevu 1 ili patentnom zahtjevu 2 ili farmaceutski pripravak prema patentnom zahtjevu 3 ili patentnom zahtjevu 4 za primjenu u liječenju, sprječavanju ili ublažavanju bolesti ili poremećaja karakteriziranog smanjenjem mišićne mase ili snage, naznačeno time, što je bolest ili poremećaj karakteriziran smanjenjem mišićne mase ili snage odabran iz skupine koja se sastoji od sarkopenije, kaheksije, ozljede mišića, propadanja/atrofije mišića, raka, pretilosti, dijabetesa, artritisa, multiple skleroze, mišićne distrofije, amiotrofične lateralne skleroze, Parkinsonove bolesti, osteoporoze, osteoartritisa, osteopenije i metaboličkog sindroma.
HRP20201729TT 2013-07-30 2020-10-27 Antitijela protiv aktivina a i njihova primjena HRP20201729T1 (hr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201361859926P 2013-07-30 2013-07-30
US201361864036P 2013-08-09 2013-08-09
US201361911834P 2013-12-04 2013-12-04
US201361913885P 2013-12-09 2013-12-09
EP14750421.1A EP3027209B1 (en) 2013-07-30 2014-07-30 Anti-activin a antibodies and uses thereof
PCT/US2014/048957 WO2015017576A1 (en) 2013-07-30 2014-07-30 Anti-activin a antibodies and uses thereof

Publications (1)

Publication Number Publication Date
HRP20201729T1 true HRP20201729T1 (hr) 2020-12-25

Family

ID=52427866

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20201729TT HRP20201729T1 (hr) 2013-07-30 2020-10-27 Antitijela protiv aktivina a i njihova primjena

Country Status (28)

Country Link
US (4) US9718881B2 (hr)
EP (4) EP3027209B1 (hr)
JP (5) JP6581085B2 (hr)
KR (2) KR102440044B1 (hr)
CN (2) CN113845594A (hr)
AU (2) AU2014296243B2 (hr)
BR (1) BR112016002164B1 (hr)
CA (1) CA2920071C (hr)
CL (1) CL2016000251A1 (hr)
CY (1) CY1123788T1 (hr)
DK (1) DK3027209T3 (hr)
EA (1) EA037926B1 (hr)
ES (1) ES2827673T3 (hr)
HK (1) HK1225322A1 (hr)
HR (1) HRP20201729T1 (hr)
HU (1) HUE052518T2 (hr)
IL (2) IL243822B (hr)
LT (1) LT3027209T (hr)
MX (2) MX371498B (hr)
PH (1) PH12016500182A1 (hr)
PT (1) PT3027209T (hr)
RS (1) RS61124B1 (hr)
SG (1) SG11201600731WA (hr)
SI (1) SI3027209T1 (hr)
TW (2) TWI655207B (hr)
UY (1) UY35682A (hr)
WO (1) WO2015017576A1 (hr)
ZA (1) ZA201601294B (hr)

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