HRP20191326T1 - Monoklonska antitijela za faktor rasta i diferencijacije 15 (gdf-15) - Google Patents
Monoklonska antitijela za faktor rasta i diferencijacije 15 (gdf-15) Download PDFInfo
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- HRP20191326T1 HRP20191326T1 HRP20191326T HRP20191326T1 HR P20191326 T1 HRP20191326 T1 HR P20191326T1 HR P20191326 T HRP20191326 T HR P20191326T HR P20191326 T1 HRP20191326 T1 HR P20191326T1
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- antigen
- antibody
- binds
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- human gdf
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- 102000000597 Growth Differentiation Factor 15 Human genes 0.000 title 1
- 108010041834 Growth Differentiation Factor 15 Proteins 0.000 title 1
- 230000004069 differentiation Effects 0.000 title 1
- 239000000427 antigen Substances 0.000 claims 26
- 102000036639 antigens Human genes 0.000 claims 26
- 108091007433 antigens Proteins 0.000 claims 26
- 101000893549 Homo sapiens Growth/differentiation factor 15 Proteins 0.000 claims 10
- 102000046181 human GDF15 Human genes 0.000 claims 10
- 125000003275 alpha amino acid group Chemical group 0.000 claims 7
- 239000000825 pharmaceutical preparation Substances 0.000 claims 6
- 241000124008 Mammalia Species 0.000 claims 5
- 210000004027 cell Anatomy 0.000 claims 5
- 238000000034 method Methods 0.000 claims 4
- 206010028980 Neoplasm Diseases 0.000 claims 3
- 201000011510 cancer Diseases 0.000 claims 3
- 238000010494 dissociation reaction Methods 0.000 claims 3
- 230000005593 dissociations Effects 0.000 claims 3
- 230000002401 inhibitory effect Effects 0.000 claims 3
- 238000005259 measurement Methods 0.000 claims 3
- 238000002198 surface plasmon resonance spectroscopy Methods 0.000 claims 3
- 230000005907 cancer growth Effects 0.000 claims 2
- 238000004113 cell culture Methods 0.000 claims 2
- 244000005700 microbiome Species 0.000 claims 2
- 210000001744 T-lymphocyte Anatomy 0.000 claims 1
- 239000013604 expression vector Substances 0.000 claims 1
- 230000006698 induction Effects 0.000 claims 1
- 210000000822 natural killer cell Anatomy 0.000 claims 1
- 239000002773 nucleotide Substances 0.000 claims 1
- 125000003729 nucleotide group Chemical group 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
Classifications
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- 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
-
- 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
-
- 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
- C07K2317/70—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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Hematology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
Claims (19)
1. Monoklonsko antitijelo koje se može vezati na humani GDF-15, ili njegov dio koji se veže na antigen, a koji se može vezati za humani GDF-15, pri čemu:
i) varijabilna domena teškog lanca obuhvaća regiju CDR3 koja sadrži sekvencu aminokiselina SEQ ID NO: 5 ili aminokiselinsku sekvencu koja je najmanje 90% identična s tim, i gdje varijabilna domena lakog lanca sadrži regiju CDR3 koja sadrži sekvencu aminokiselina SEQ ID NO: 7 ili s njima najmanje 85% identična aminokiselinska sekvenca, i gdje antitijelo ili njegov dio koji veže antigen može inhibirati rast raka kod sisavca, ili
ii) vezanje se veže na konformacijski ili diskontinuirani epitop na humanom GDF-15 koji se sastoji od aminokiselinskih sekvenci SEQ ID NO: 25 i SEQ ID NO: 26, i gdje je antitijelo ili njegov dio koji veže antigen sposoban za inhibiranje rasta raka kod sisavaca.
2. Monoklonsko antitijelo ili njegov dio koji se veže na antigen sukladno zahtjevu 1, naznačeno time, da je sisavac ljudski pacijent.
3. Monoklonsko antitijelo ili njegov dio koji se veže za antigen sukladno zahtjevu 1 ili 2, naznačeno time, da je antitijelo antitijelo na humani GDF-15 koje se može dobiti iz stanične linije B1-23 pohranjene kod Deutsche Sammlung für Mikroorganismen und Zellkulturen GmbH (DMSZ) (njemačkoj zbirci mikroorganizama i staničnih kultura) pod pristupnim brojem DSM ACC3142 ili njegovim dijelom koji se veže na antigen.
4. Monoklonsko antitijelo ili njegov dio koji se veže na antigen sukladno bilo kojem od zahtjeva 1-3, naznačeno time, da je humani GDF-15 rekombinantni humani GDF-15 koji ima aminokiselinski slijed predstavljen SEQ ID NO: 8.
5. Monoklonsko antitijelo ili njegov dio koji se veže na antigen sukladno bilo kojem od patentnih zahtjeva 1-4, naznačeno time, da antitijelo ili njegov dio koji se veže za antigen je antitijelo ili njegov dio koji se veže za antigen sukladno zahtjevu 1 i), i gdje je vezanje vezivo na konformacijski ili diskontinuirani epitop na humanom GDF-15.
6. Monoklonsko antitijelo ili njegov dio koji se veže na antigen sukladno zahtjevu 5, naznačeno time, da antitijelo ili njegov dio koji se veže na antigen je antitijelo ili njegov dio koji se veže na antigen sukladno zahtjevu 1 i), naznačen time, da vezanje na konformacijski ili diskontinuirani epitop na humanom GDF-15 se veže na konformacijski ili diskontinuirani epitop koji sadrži aminokiselinske sekvence SEQ ID NO: 25 i SEQ ID NO: 26.
7. Monoklonsko antitijelo ili njegov dio koji se veže na antigen sukladno bilo kojem od zahtjeva 1 do 6, naznačen time, da antitijelo ili njegov dio koji veže antigen ima konstantu ravnoteže disocijacije za humani GDF-15 koja je jednaka ili manja od 5 nM kako je izmjereno mjerenjima površinske plazmonske rezonancije.
8. Monoklonsko antitijelo ili njegov dio koji se veže na antigen sukladno bilo kojem od zahtjeva 1 do 7, naznačen time, da antitijelo ili njegov dio koji veže antigen ima konstantu ravnoteže disocijacije za ljudski GDF-15 koja je jednaka ili manja od 2 nM kako je izmjereno mjerenjima površinske plazmonske rezonancije.
9. Monoklonsko antitijelo ili njegov dio koji se veže na antigen sukladno zahtjevu 7 ili 8, naznačeno time da je ravnotežna konstanta disocijacije izmjerena mjerenjima površinske plazmonske rezonance u skladu s Primjerom 1.
10. Farmaceutski pripravak, naznačen time što sadrži antitijelo ili njegov dio koji se veže na antigen sukladno bilo kojem od zahtjeva 1 do 9.
11. Antitijelo ili njegov dio koji se veže na antigen sukladno bilo kojem od zahtjeva 1 do 9 ili farmaceutski pripravak sukladno zahtjevu 10, naznačen time, da se upotrebljava u postupku za liječenje raka kod sisavca, postupak obuhvaća primjenu antitijela ili dijela koji veže antigen. ili njegovog farmaceutskog pripravka navedenom sisavcu.
12. Antitijelo ili njegov dio koji se veže za antigen ili farmaceutski pripravak sukladno zahtjevu 11 za uporabu sukladno zahtjevu 11, naznačen time, što je sisavac ljudski pacijent.
13. Antitijelo ili njegov dio koji se veže za antigen ili farmaceutski pripravak sukladno bilo kojem od zahtjeva 11 do 12, naznačen time, da se upotrebljava sukladno bilo kojem od zahtjeva 11 do 12, naznačen time, da postupak uključuje inhibiranje rasta raka.
14. Antitijelo ili njegov dio koji se veže za antigen ili farmaceutski pripravak sukladno bilo kojem od zahtjeva 12 do 13, naznačen time, da se koristi u skladu s bilo kojim od patentnih zahtjeva 12 do 13, naznačen time što metoda uključuje indukciju ubijanja stanica raka NK stanicama. i CD8 + T stanice u ljudskog pacijenta.
15. Komplet koji sadrži farmaceutski sastav sukladno zahtjevu 10.
16. Komplet sukladno zahtjevu 15, naznačen time, da je za uporabu u skladu s bilo kojim od patentnih zahtjeva 11 do 14.
17. Vektor ekspresije koji sadrži nukleotidnu sekvencu koja kodira antitijelo ili njegov dio koji se veže za antigen sukladno bilo kojem od zahtjeva 1-9.
18. Stanična linija sposobna proizvesti antitijelo ili njegov dio koji se veže na antigen sukladno bilo kojem od zahtjeva 1 do 9.
19. Stanična linija sukladno zahtjevu 18, naznačena time, da je stanična linija stanična linija B1-23 deponirana u Deutsche Sammlung für Mikroorganismen und Zellkulturen GmbH (DMSZ) (njemačkoj zbirci mikroorganizama i staničnih kultura) pod pristupnim brojem DSM ACC3142.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP12186185 | 2012-09-26 | ||
PCT/EP2013/070127 WO2014049087A1 (en) | 2012-09-26 | 2013-09-26 | Monoclonal antibodies to growth and differentiation factor 15 (gdf-15) |
EP13776433.8A EP2900263B1 (en) | 2012-09-26 | 2013-09-26 | Monoclonal antibodies to growth and differentiation factor 15 (gdf-15) |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20191326T1 true HRP20191326T1 (hr) | 2019-11-01 |
Family
ID=46888333
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20191326 HRP20191326T1 (hr) | 2012-09-26 | 2019-07-23 | Monoklonska antitijela za faktor rasta i diferencijacije 15 (gdf-15) |
Country Status (23)
Country | Link |
---|---|
US (3) | US20150239968A1 (hr) |
EP (2) | EP2900263B1 (hr) |
JP (4) | JP2015532271A (hr) |
KR (1) | KR101838786B1 (hr) |
CN (1) | CN104853775B (hr) |
AU (2) | AU2013322628B2 (hr) |
CA (1) | CA2886207C (hr) |
CY (1) | CY1121832T1 (hr) |
DK (1) | DK2900263T3 (hr) |
ES (1) | ES2742287T3 (hr) |
HK (1) | HK1210950A1 (hr) |
HR (1) | HRP20191326T1 (hr) |
HU (1) | HUE044363T2 (hr) |
IL (2) | IL237828B (hr) |
LT (1) | LT2900263T (hr) |
NZ (1) | NZ706189A (hr) |
PL (1) | PL2900263T3 (hr) |
PT (1) | PT2900263T (hr) |
RS (1) | RS59045B1 (hr) |
SG (1) | SG11201502279YA (hr) |
SI (1) | SI2900263T1 (hr) |
TR (1) | TR201910744T4 (hr) |
WO (1) | WO2014049087A1 (hr) |
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GB2524553C (en) * | 2014-03-26 | 2017-07-19 | Julius-Maximilians-Universitãt Würzburg | Monoclonal antibodies to growth and differentiation factor 15 (GDF-15), and uses thereof for treating cancer cachexia |
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KR102010652B1 (ko) * | 2017-08-21 | 2019-08-13 | 서울대학교병원 | 간질환 예측 또는 진단용 조성물 및 이를 이용한 간질환 예측 또는 진단 방법 |
WO2021111636A1 (ja) * | 2019-12-06 | 2021-06-10 | 大塚製薬株式会社 | 抗gdf15抗体 |
CN112698042A (zh) * | 2020-12-17 | 2021-04-23 | 北京赛诺浦生物技术有限公司 | 检测人生长分化因子-15的荧光免疫层析试纸条及其制备方法和应用 |
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CA3000290C (en) * | 2015-10-02 | 2023-02-21 | Julius-Maximilians-Universitat Wurzburg | Gdf-15 as a diagnostic marker to predict the clinical outcome of a treatment with immune checkpoint blockers |
PL3355919T3 (pl) * | 2015-10-02 | 2023-03-20 | Julius-Maximilians-Universität Würzburg | Terapia skojarzona z użyciem inhibitorów ludzkiego czynnika wzrostu i różnicowania 15 (gdf-15) oraz blokerów punktów kontrolnych układu odpornościowego |
US11566066B2 (en) | 2018-08-20 | 2023-01-31 | Pfizer Inc. | Anti-GDF15 antibodies, compositions and methods of use |
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