ME02239B - Humana antitela visokog afiniteta prema humanom nervnom faktoru rasta - Google Patents

Humana antitela visokog afiniteta prema humanom nervnom faktoru rasta

Info

Publication number
ME02239B
ME02239B MEP-2014-642A MEP64214A ME02239B ME 02239 B ME02239 B ME 02239B ME P64214 A MEP64214 A ME P64214A ME 02239 B ME02239 B ME 02239B
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ME
Montenegro
Prior art keywords
antibody
pain
antigen
binding fragment
human
Prior art date
Application number
MEP-2014-642A
Other languages
English (en)
French (fr)
Inventor
Richard Torres
Joel H Martin
Lynn Macdonald
Marc R Morra
Joel C Reinhardt
Original Assignee
Regeneron Pharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Regeneron Pharma filed Critical Regeneron Pharma
Publication of ME02239B publication Critical patent/ME02239B/me

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IG], 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
    • 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
    • A61P19/06Antigout agents, e.g. antihyperuricemic or uricosuric 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
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • 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
    • 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
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • 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
    • C07K2317/90Immunoglobulins 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Toxicology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (15)

1. Humano antitelo ili antigen-vezujući fragment antitela, koji specifično vezuje humani nervni faktor rasta (NGF) sa KD od 1 pM ili manje, kako je izmereno uz pomoć površinske plazmon rezonance, pri čemu antitelo ili fragment antitela sadrži (a)    region koji određuje komplementarnost teškog lanca 3 (HCDR3) i CDR3 lakog lanca (LCDR3), pri čemu HCDR3 i LCDR3 sadrže aminikiselinske sekvence navedene u SEQ ID NO:90, odnosno 98, i (b)    HCDR1, HCDR2, LCDR1 i LCDR2, pri čemu: HCDR1 je SEQ ID NO:86, HCDR2 je SEQ ID NO:88, LCDR1 je SEQ ID NO:94 i LCDR2 je SEQ ID NO:96.
2. Humano antitelo ili antigen-vezujući fragment prema zahtevu 1, koji specifično vezuje humani NGF sa Kd od 0.5 pM ili manje.
3. Humano antitelo ili antigen-vezujući fragment prema zahtevu 1 ili 2, pri čemu navedeno antitelo ili njegov antigen-vezujući fragment sadrži varijabilni region teškog lanca (HCVR) i varijabilni region lakog lanca (LCVR), pri čemu HCVR i LCVR sadrže aminokiselinske sekvence navedene u SEQ ID NO:108, odnosno 110.
4. Humano antitelo ili antigen-vezujući fragment prema zahtevu 1, 2 ili 3, koji vezuje humani NGF sa Kd koja je približno 2 do približno 10-puta veća nego kada antitelo ili fragment vezuje NGF pacova i miša.
5. Molekul nukleinske kiseline, koji kodira humano antitelo ili antigen-vezujući fragment prema bilo kom od zahteva 1 do 4.
6. Ekspresioni vektor koji sadrži nukleinsku kiselinu iz zahteva 5.
7. Postupak proizvodnje antitela prema humanom NGF-u ili antigen-vezujućeg fragmenta antitela koji obuhvata korake uvođenja ekspresionog vektora iz zahteva 6 u izolovanu ćeliju domaćina, uzgoj ćelije pod uslovima koji omogućuju proizvodnju antitela ili fragmenta antitela, i dobijanje tako proizvedenog antitela ili fragmenta antitela, pri čemu je poželjno ćelija domaćina ćelija E. coli, CHO ćelija ili COS ćelija.
8.    Farmaceutska smeša koja sadrži antitelo ili antigen-vezujući fragment antitela prema bilo kom od zahteva 1 do 4 i farmaceutski prihvatljiv nosač.
9.    Farmaceutska smeša prema zahtevu 8 koja dalje sadrži drugo terapeutsko sredstvo odabrano od: inhibitora interleukina-1 (IL-1), antiepileptičnog leka, antagonista citokina i neurotrofina.
10. Antitelo ili antigen-vezujući fragment antitetla prema bilo kom od zahteva 1 do 4 za korišćenje u postupku ublažavanja ili inhibiranja NGF-om posredovane bolesti ili stanja kod čoveka, koje su odabrane od: inflamatornog bola, post-operativnog incizionog bola, neuropatskog bola, bola zbog preloma, bola zbog zglobnog gihta, post-herpesne neuralgije, bola proisteklog od opekotina, kancerskog bola, bola osteoartritisa ili reumatoidnog artritisa, išijasnog bola, bola povezanog sa krizama bolesti srpastih ćelija ili post-herpesne neuralgije.
11. Korišćenje antitela ili antigen-vezujućeg fragmenta antitela prema bilo kom od zahteva 1 do 4 u proizvodnji leka za korišćenje u postupku ublažavanja ili inhibiranja NGF-om posredovane bolesti ili stanja kod čoveka, koje su odabrane od: inflamatornog bola, post-operativnog incizionog bola, neuropatskog bola, bola zbog preloma, bola zbog zglobnog gihta, post-herpesne neuralgije, bola proisteklog od opekotina, kancerskog bola, bola osteoartritisa ili reumatoidnog artritisa, išijasnog bola, bola povezanog sa krizama bolesti srpastih ćelija ili post-herpesne neuralgije.
12. Antitelo ili antigen-vezujući fragment antitela prema bilo kom od zahteva 1 do 4 za korišćenje prema zahtevu 10, pri čemu navedeni postupak obuhvata primenu prvog i drugog terapeutskog sredstva humanom ispitaniku kome je to potrebno, pri čemu je prvo terapeutsko sredstvo navedeno antitelo ili antigen-vezujući fragment, i pri čemu je poželjno drugo terapeutsko sredstvo: inhibitor interleukina-1 (IL-1), antiepileptični lek, antagonist citokina ili neurotrofin.
13. Korišćenje prema zahtevu 11 navedenog antitela ili antigen-vezujućeg fragmenta iz bilo kog od zahteva 1 do 4, pri čemu navedeni postupak obuhvata primenu prvog i drugog terapeutskog sredstva humanom ispitaniku kome je to potrebno, pri čemu je prvo terapeutsko sredstvo navedeno antitelo ili antigen-vezujući fragment, i pri čemu je poželjno drugo terapeutsko sredstvo: inhibitor interleukina-1 (IL-1), antiepileptični lek, antagonist citokina ili neurotrofin.
14. Antitelo ili antigen vezujući fragment iz bilo kog od zahteva 1 do 4 za korišćenje prema zahtevu 10 ili 12, pri čemu su stanje ili bolest, koji su posredovani NGF-om, inhibirani bez značajnog narušavanja motorne koordinacije.
15. Korišćenje prema zahtevu 11 ili 13 navedenog antitela ili antigen vezujućeg fragmenta iz bilo kog od zahteva 1 do 4, pri čemu su stanje ili bolest, posredovani NGF-om, inhibirani bez značajnog narušavanja motorne koordinacije.
MEP-2014-642A 2007-08-10 2008-08-08 Humana antitela visokog afiniteta prema humanom nervnom faktoru rasta ME02239B (me)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US96422407P 2007-08-10 2007-08-10
US99452607P 2007-09-20 2007-09-20
US6286008P 2008-01-28 2008-01-28
US7925908P 2008-07-09 2008-07-09
PCT/US2008/072561 WO2009023540A1 (en) 2007-08-10 2008-08-08 High affinity human antibodies to human nerve growth factor
EP08782673.1A EP2187964B1 (en) 2007-08-10 2008-08-08 High affinity human antibodies to human nerve growth factor

Publications (1)

Publication Number Publication Date
ME02239B true ME02239B (me) 2015-04-30

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MEP-2010-24A ME00977B (me) 2007-08-10 2008-08-08 Humana antitijela visokog afiniteta prema humanom nervnom faktoru rasta

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EP (2) EP2572729A3 (me)
JP (1) JP5632744B2 (me)
KR (2) KR101709488B1 (me)
CN (1) CN101827609B (me)
AU (1) AU2008287037B2 (me)
BR (1) BRPI0815370B8 (me)
CA (1) CA2695997C (me)
CO (1) CO6261383A2 (me)
CR (1) CR11298A (me)
CY (1) CY1116072T1 (me)
DK (1) DK2187964T3 (me)
DO (1) DOP2010000054A (me)
EC (1) ECSP10010029A (me)
ES (1) ES2517872T3 (me)
HR (1) HRP20141025T1 (me)
IL (1) IL203558A (me)
MA (1) MA31695B1 (me)
ME (2) ME02239B (me)
MX (1) MX2010001395A (me)
MY (2) MY153781A (me)
NI (1) NI201000021A (me)
NZ (1) NZ583200A (me)
PL (1) PL2187964T3 (me)
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