HRP20150171T1 - Anti-aktivinska antitijela a i njihove primjene - Google Patents

Anti-aktivinska antitijela a i njihove primjene Download PDF

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Publication number
HRP20150171T1
HRP20150171T1 HRP20150171TT HRP20150171T HRP20150171T1 HR P20150171 T1 HRP20150171 T1 HR P20150171T1 HR P20150171T T HRP20150171T T HR P20150171TT HR P20150171 T HRP20150171 T HR P20150171T HR P20150171 T1 HRP20150171 T1 HR P20150171T1
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Croatia
Prior art keywords
activin
antigen
antibody
binding
binding fragment
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HRP20150171TT
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English (en)
Inventor
Hq Han
Qing Chen
Keith Soo-Nyung Kwak
Xiaolan Zhou
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Amgen Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39103486&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20150171(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 HRP20150171T1 publication Critical patent/HRP20150171T1/hr

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567—Framework region [FR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

Claims (19)

1. Izolirano protutijelo, ili njegov antigenski vežući fragment, naznačeno time da sadrži: a) varijabilnu domenu lakog lanca (VL) koja sadrži: i CDR1 sekvencu lakog lanca SEQ ID NO: 11; ii CDR2 sekvencu lakog lanca SEQ ID NO: 12; i iii CDR3 sekvencu lakog lanca SEQ ID NO: 13; i b) varijabilnu domenu teškog lanca (VH) koja sadrži: i CDR1 sekvencu teškog lanca SEQ ID NO: 62; ii CDR2 sekvencu teškog lanca SEQ ID NO: 63; i iii CDR3 sekvencu teškog lanca SEQ ID NO: 64, pri čemu se navedeno protutijelo ili njegov antigenski vežući fragment specifično veže za ljudski aktivin A.
2. Izolirano protutijelo, ili njegov antigenski vežući fragment, u skladu s patentnim zahtjevom 1, naznačeno time da sadrži: a) sekvencu varijabilne domene lakog lanca SEQ ID NO: 11; b) sekvencu varijabilne domene teškog lanca SEQ ID NO: 10; ili c) varijabilnu domenu lakog lanca iz (a) i varijabilnu domenu teškog lanca iz (b).
3. Izolirano protutijelo, ili njegov antigenski vežući fragment, u skladu s patentnim zahtjevom 1, naznačeno time da, kada se veže za aktivin A: a) inhibira aktivin A; b) poprečno kompetira s referentnim protutijelom za vezanje na aktivin A; c) veže se na isti epitop aktivina A kao navedeno referentno protutijelo; d) veže se na aktivin A s uglavnom istim Kd kao navedeno referentno protutijelo; ili e) veže se na aktivin A s uglavnom istom sporijom brzinom kao navedeno referentno protutijelo; pri čemu referentno protutijelo sadrži kombinaciju sekvenci varijabilne domene lakog lanca i teškog lanca izabranih iz skupine kombinacija koje se sastoje od: SEQ ID NO: 9 i 10.
4. Izolirano protutijelo, ili njegov antigenski vežući fragment, u skladu s patentnim zahtjevom 1 ili 2, naznačeno time da, kada se veže na ljudski aktivin A, inhibira vezanje aktivina A na receptor ljudskog aktivina A.
5. Izolirano protutijelo, ili njegov antigenski vežući fragment, u skladu s patentnim zahtjevom 1 ili 2, naznačeno time da navedeno protutijelo ili njegov antigenski vežući fragment ima najmanje jedno in vivo biološko djelovanje odabrano iz skupine koju čine: slabljenje kaheksije kod miševa koji u debelom crijevu imaju tumor; poboljšanje kod slučajeva gubitka tjelesne težine kod miševa koji u debelom crijevu imaju tumor; poboljšanje kod slučajeva gubitka tjelesne težine kod životinjskog modela reumatoidnog artritisa induciranog kolagenom; poboljšanje kod slučajeva gubitka mišićne mase kod životinjskog modela reumatoidnog artritisa induciranog kolagenom; poboljšanje kod slučajeva gubitka masnog tkiva kod životinjskog modela reumatoidnog artritisa induciranog kolagenom te poboljšanje kod slučajeva gubitka tjelesne težine kod transficiranog životinjskog modela s AAV-aktivinom A.
6. Izolirano protutijelo, ili njegov antigenski vežući fragment, u skladu s patentnim zahtjevom 1 ili 2, naznačeno time da sadrži izolirano posve ljudsko protutijelo koji se specifično veže na područje čvora cisteina (aminokiseline C11-S33 i/ili aminokiseline C81-E111) aktivina A, pri čemu navedeno protutijelo ili njegov antigenski vežući fragment ima najmanje jedno in vivo biološko djelovanje odabrano iz skupine koju čine: slabljenje kaheksije kod miševa koji u debelom crijevu imaju tumor; poboljšanje kod slučajeva gubitka tjelesne težine kod miševa koji u debelom crijevu imaju tumor; poboljšanje kod slučajeva gubitka tjelesne težine kod životinjskog modela reumatoidnog artritisa induciranog kolagenom; poboljšanje kod slučajeva gubitka mišićne mase kod životinjskog modela reumatoidnog artritisa induciranog kolagenom; poboljšanje kod slučajeva gubitka masnog tkiva kod životinjskog modela reumatoidnog artritisa induciranog kolagenom te poboljšanje kod slučajeva gubitka tjelesne težine kod transficiranog životinjskog modela s AAV-aktivinom A.
7. Izolirano protutijelo, ili njegov antigenski vežući fragment, u skladu s patentnim zahtjevom 1 ili 2, naznačeno time da sadrži izolirano posve ljudsko protutijelo koje a) se posebno veže na područje čvora cisteina (aminokiseline C11-S33 i/ili aminokiseline C81-E111) aktivina A, pri čemu navedeni antigenski vezni protein inhibira vezanje aktivina A za receptor aktivina A in vitro, ili b) se posebno veže na područje čvora cisteina (aminokiseline C11-S33 i/ili aminokiseline C81-E111) aktivina A, pri čemu navedeni antigenski vezni protein inhibira vezanje aktivina A za receptor aktivina A in vivo, ili c) se posebno veže za aminokiseline K13-Y39 aktivina A, pri čemu navedeni antigenski vezni protein inhibira vezanje aktivina A za receptor aktivina A in vitro, ili d) se posebno veže za aminokiseline V82-N107 aktivina A, pri čemu navedeni antigenski vezni protein inhibira vezanje aktivina A za receptor aktivina A in vitro, ili e) se posebno veže za aminokiseline K13-Y39 aktivina A, pri čemu navedeni antigenski vezni protein inhibira vezanje aktivina A za receptor aktivina A in vivo, ili f) se posebno veže za aminokiseline V82-N107 aktivina A, pri čemu navedeni antigenski vezni protein inhibira vezanje aktivina A za receptor aktivina A in vivo.
8. Izolirano protutijelo, ili njegov antigenski vežući fragment, u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačeno time da sadrži i konstantnu sekvencu kappa lakog lanca SEQ ID NO: 84, 100 ili 108 i/ili konstantnu sekvencu teškog lanca SEQ ID NO: 214, 215 ili 221.
9. Izolirano protutijelo, ili njegov antigenski vežući fragment, u skladu s patentnim zahtjevom 8, naznačeno time da sadrži konstantnu sekvencu kappa lakog lanca SEQ ID NO: 84 i konstantnu sekvencu teškog lanca SEQ ID NO: 214.
10. Izolirano protutijelo, ili njegov antigenski vežući fragment, u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačeno time da mu je sklonost vezanja (KD) za ljudski aktivin A manja ili jednaka 1 × 10-11 M.
11. Izolirani polinukleotid naznačen time da sadrži sekvencu koja kodira laki lanac, teški lanac ili oba lanca protutijela, ili njegov antigenski vežući fragment, u skladu s bilo kojim od patentnih zahtjeva 1 do 10.
12. Vektor naznačen time da sadrži polinukleotid u skladu s patentnim zahtjevom 11.
13. Vektor u skladu s patentnim zahtjevom 12, naznačen time da je odabran iz skupine koja se sastoji od plazmida, virusnog vektora, vektora sisavaca koji nisu episomalni, ekspresijskih vektora i rekombinantnog ekspresijskog vektora.
14. Izolirana stanica naznačena time da sadrži polinukleotid u skladu s patentnim zahtjevom 11 ili u koju je uveden rekombinantni ekspresijski vektor u skladu s patentnim zahtjevom 13.
15. Izolirana stanica u skladu s patentnim zahtjevom 14 naznačena time da je hibridom ili stanica jajnika kineskog hrčka (CHO).
16. Farmaceutski pripravak, naznačen time da sadrži protutijelo, ili njegov antigenski vežući fragment, u skladu s bilo kojim od patentnih zahtjeva 1 do 10.
17. Farmaceutski pripravak u skladu s patentnim zahtjevom 16, naznačen time da sadrži i jednu ili više tvari izabranih iz skupine koja se sastoji od pufera, antioksidansa, polipetida niske molekularne težine, proteina, aminokiseline, ugljikohidrata, kelirajućeg sredstva, stabilizatora i pomoćnog sredstva.
18. Farmaceutski pripravak u skladu s patentnim zahtjevom 16 ili 17, naznačen time da se upotrebljava u medicini.
19. Farmaceutski pripravak u skladu s patentnim zahtjevom 18, naznačen time da se upotrebljava u liječenju karcinoma.
HRP20150171TT 2006-09-08 2015-02-13 Anti-aktivinska antitijela a i njihove primjene HRP20150171T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US84343006P 2006-09-08 2006-09-08
US95665307P 2007-08-17 2007-08-17
EP07842088.2A EP2064239B1 (en) 2006-09-08 2007-09-07 Anti-activin a antibodies and uses thereof
PCT/US2007/077923 WO2008031061A2 (en) 2006-09-08 2007-09-07 Anti-activin a antibodies and uses thereof

Publications (1)

Publication Number Publication Date
HRP20150171T1 true HRP20150171T1 (hr) 2015-05-22

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ID=39103486

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20150171TT HRP20150171T1 (hr) 2006-09-08 2015-02-13 Anti-aktivinska antitijela a i njihove primjene
HRP20161300TT HRP20161300T1 (hr) 2006-09-08 2016-10-10 Protutijela protiv aktivina a i njihova upotreba

Family Applications After (1)

Application Number Title Priority Date Filing Date
HRP20161300TT HRP20161300T1 (hr) 2006-09-08 2016-10-10 Protutijela protiv aktivina a i njihova upotreba

Country Status (22)

Country Link
US (5) US8309082B2 (hr)
EP (5) EP3730517A1 (hr)
JP (3) JP5497438B2 (hr)
AR (1) AR062703A1 (hr)
AU (1) AU2007294580C1 (hr)
CA (1) CA2661878C (hr)
CL (1) CL2007002567A1 (hr)
CY (2) CY1116037T1 (hr)
DK (2) DK2559705T3 (hr)
ES (2) ES2528798T3 (hr)
HR (2) HRP20150171T1 (hr)
HU (1) HUE030463T2 (hr)
LT (1) LT2559705T (hr)
ME (1) ME02539B (hr)
MX (1) MX2009002571A (hr)
PE (1) PE20080914A1 (hr)
PL (2) PL2064239T3 (hr)
PT (2) PT2559705T (hr)
RS (2) RS53819B1 (hr)
SI (2) SI2559705T1 (hr)
TW (1) TW200819466A (hr)
WO (1) WO2008031061A2 (hr)

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