HRP20200034T1 - Monoklonska protutijela protiv čimbenika rasta i diferencijacije 15 (gdf-15), te njihova upotreba u liječenju kaheksije uzrokovane rakom i raka - Google Patents

Monoklonska protutijela protiv čimbenika rasta i diferencijacije 15 (gdf-15), te njihova upotreba u liječenju kaheksije uzrokovane rakom i raka Download PDF

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Publication number
HRP20200034T1
HRP20200034T1 HRP20200034TT HRP20200034T HRP20200034T1 HR P20200034 T1 HRP20200034 T1 HR P20200034T1 HR P20200034T T HRP20200034T T HR P20200034TT HR P20200034 T HRP20200034 T HR P20200034T HR P20200034 T1 HRP20200034 T1 HR P20200034T1
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Croatia
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amino acid
antibody
acid sequence
antigen
seq
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HRP20200034TT
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English (en)
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Jörg WISCHHUSEN
Markus JUNKER
Tina SCHÄFER
Dirk PÜHRINGER
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Julius-Maximilians-Universität Würzburg
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Priority claimed from GB1405477.9A external-priority patent/GB2524553C/en
Priority claimed from GB1405475.3A external-priority patent/GB2524552B/en
Application filed by Julius-Maximilians-Universität Würzburg filed Critical Julius-Maximilians-Universität Würzburg
Publication of HRP20200034T1 publication Critical patent/HRP20200034T1/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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • 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
    • 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
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • 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
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • 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
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/10Cells modified by introduction of foreign genetic material

Claims (16)

1. Monoklonsko protutijelo koje se može vezati na ljudski GDF-15, ili njegov dio koji se veže na antigen, naznačeno time što je vezanje vezanje na konformacijski ili diskontinuirani epitop na ljudskom GDF-15 kojeg sadrže aminokiselinski sljedovi SEQ ID No: 25 i SEQ ID No: 26, gdje konstantna domena teškog lanca ima aminokiselinski slijed SEQ ID No: 29, ili aminokiselinski slijed koji mu je u najmanju ruku istovjetan 85 %, te što konstantna domena lakog lanca ima aminokiselinski slijed SEQ ID No: 32, ili aminokiselinski slijed koji mu je u najmanju ruku 85 % istovjetan.
2. Monoklonsko protutijelo koje se može vezati na ljudski GDF-15, ili njegov dio koji se veže na antigen, gdje varijabilna domena teškog lanca sadrži područje CDR3 koje ima aminokiselinski slijed SEQ ID NO: 5, te gdje varijabilna domena lakog lanca sadrži područje CDR3 koje ima aminokiselinski slijed SEQ ID NO: 7, naznačeno time što konstantna domena teškog lanca ima aminokiselinski slijed SEQ ID No: 29, ili aminokiselinski slijed koji mu je u najmanju ruku istovjetan 85 %, što konstantna domena lakog lanca ima aminokiselinski slijed SEQ ID No: 32, ili aminokiselinski slijed koji mu je u najmanju ruku 85 % istovjetan, što varijabilna domena teškog lanca ima aminokiselinski slijed SEQ ID No: 28, te što varijabilna domena lakog lanca ima aminokiselinski slijed SEQ ID No: 31.
3. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1-2, naznačeno time što je protutijelo humanizirano protutijelo.
4. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačeno time što je namijenjen upotrebi u lijeku.
5. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačeno time što je namijenjeno upotrebi u postupku liječenja kaheksije uzrokovane rakom kod sisavca.
6. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačeno time što je namijenjeno upotrebi u postupku liječenja raka kod sisavca.
7. Komplet, naznačen time što sadrži protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1-3.
8. Eksprimirajući vektor, naznačen time što sadrži nukleotidni slijed koji kodira protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1-3.
9. Stanična linija, naznačena time što može proizvoditi protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1 do 3.
10. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 5 do 6, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 5 do 6, naznačeno time što je postupak postupak istodobno liječenja raka i liječenja kaheksije uzrokovane rakom kod istog sisavca.
11. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 5 do 6 ili 10, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 5 do 6 ili 10, naznačeno time što stanice raka iz sisavca endogeno eksprimiraju GDF-15 i/ili stanice raka iz sisavca stimuliraju endogeno eksprimiranje GDF-15 u nekanceroznim stanicama iz sisavca.
12. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 5 do 6 ili 10 do 11, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 5 do 6 ili 10 do 11, naznačeno time što stanice raka iz sisavca endogeno eksprimiraju GDF-15.
13. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 5 do 6 ili 10 do 12, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 5 do 6 ili 10 do 12, naznačeno time što je sisavac ljudski pacijent.
14. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 10-13, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 10-13, ili protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1 ili 3, naznačeno time što varijabilna domena teškog lanca sadrži područje CDR3 koje ima aminokiselinski slijed SEQ ID NO: 5 ili aminokiselinski slijed koji mu je u najmanju ruku istovjetan 90 %, te što varijabilna domena lakog lanca sadrži područje CDR3 koje ima aminokiselinski slijed SEQ ID NO: 7 ili aminokiselinski slijed koji mu je u najmanju ruku istovjetan 85 %.
15. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 10-13, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 10-13, ili protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 2 i 3, naznačeno time što je vezanje vezanje na konformacijski ili diskontinuirani epitop na ljudskom GDF-15 kojeg sadrže aminokiselinski sljedovi SEQ ID No: 25 i SEQ ID No: 26.
16. Protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 10-15, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 10-15, ili protutijelo, ili njegov dio koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačeno time što varijabilna domena teškog lanca sadrži područje CDR1 koje ima aminokiselinski slijed SEQ ID NO: 3 i područje CDR2 koje ima aminokiselinski slijed SEQ ID NO: 4, te što varijabilna domena lakog lanca sadrži područje CDR1 koje ima aminokiselinski slijed SEQ ID NO: 6 i područje CDR2 koje ima aminokiselinski slijed Ser-Ala-Ser.
HRP20200034TT 2014-03-26 2020-01-09 Monoklonska protutijela protiv čimbenika rasta i diferencijacije 15 (gdf-15), te njihova upotreba u liječenju kaheksije uzrokovane rakom i raka HRP20200034T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB1405477.9A GB2524553C (en) 2014-03-26 2014-03-26 Monoclonal antibodies to growth and differentiation factor 15 (GDF-15), and uses thereof for treating cancer cachexia
GB1405475.3A GB2524552B (en) 2014-03-26 2014-03-26 Monoclonal antibodies to growth and differentiation factor 15 (GDF-15), and use thereof for treating cancer
PCT/EP2015/056654 WO2015144855A1 (en) 2014-03-26 2015-03-26 Monoclonal antibodies to growth and differentiation factor 15 (gdf-15), and uses thereof for treating cancer cachexia and cancer
EP15712629.3A EP3122775B1 (en) 2014-03-26 2015-03-26 Monoclonal antibodies to growth and differentiation factor 15 (gdf-15), and uses thereof for treating cancer cachexia and cancer

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HRP20231514TT HRP20231514T1 (hr) 2014-03-26 2015-03-26 Monoklonska antitijela za faktor rasta i diferencijacije 15 (gdf-15), te njihova uporaba za liječenje tumorske kaheksije i raka
HRP20200034TT HRP20200034T1 (hr) 2014-03-26 2020-01-09 Monoklonska protutijela protiv čimbenika rasta i diferencijacije 15 (gdf-15), te njihova upotreba u liječenju kaheksije uzrokovane rakom i raka

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AU (2) AU2015238264B2 (hr)
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HUE064573T2 (hu) 2024-03-28
EP4316596A2 (en) 2024-02-07
BR122023027559A2 (pt) 2024-01-30
KR102520978B1 (ko) 2023-04-11
EP3653644B1 (en) 2023-11-15
EP4316596A3 (en) 2024-04-17
CN106536553A (zh) 2017-03-22
ES2965626T3 (es) 2024-04-16
HUE047398T2 (hu) 2020-04-28
IL248038A0 (en) 2016-11-30
US20180298091A1 (en) 2018-10-18
US20170204174A1 (en) 2017-07-20
AU2015238264B2 (en) 2020-09-03
JP2021119138A (ja) 2021-08-12
JP2023098966A (ja) 2023-07-11
US11760795B2 (en) 2023-09-19
ES2763859T3 (es) 2020-06-01
JP6865585B2 (ja) 2021-04-28
US20200308265A1 (en) 2020-10-01
SI3122775T1 (sl) 2020-02-28
US20200308264A1 (en) 2020-10-01
US11634482B2 (en) 2023-04-25
EP3653644A1 (en) 2020-05-20
PT3122775T (pt) 2019-12-26
US20230382987A1 (en) 2023-11-30
EP3122775B1 (en) 2019-11-13
PL3122775T3 (pl) 2020-05-18
DK3122775T3 (da) 2020-02-03
KR20160139005A (ko) 2016-12-06
LT3653644T (lt) 2024-01-25
NZ724649A (en) 2022-07-01
CY1122456T1 (el) 2021-01-27
IL276405A (en) 2020-09-30
HRP20231514T1 (hr) 2024-03-01
EP3122775A1 (en) 2017-02-01
US10604565B2 (en) 2020-03-31
BR112016022013A2 (pt) 2017-10-31
IL248038B (en) 2020-08-31
IL276405B (en) 2021-07-29
WO2015144855A1 (en) 2015-10-01
JP2017508475A (ja) 2017-03-30
CA2943694A1 (en) 2015-10-01
PT3653644T (pt) 2023-12-19
AU2020260440B2 (en) 2024-03-21
AU2015238264A1 (en) 2016-10-20
AU2020260440A1 (en) 2020-11-26
PL3653644T3 (pl) 2024-03-04
RS59700B1 (sr) 2020-01-31
CN106536553B (zh) 2021-03-12
DK3653644T3 (da) 2023-12-18
LT3122775T (lt) 2020-02-10

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