HRP20230093T1 - Humanizirana anti-c1s protutijela i postupci njihove primjene - Google Patents
Humanizirana anti-c1s protutijela i postupci njihove primjene Download PDFInfo
- Publication number
- HRP20230093T1 HRP20230093T1 HRP20230093TT HRP20230093T HRP20230093T1 HR P20230093 T1 HRP20230093 T1 HR P20230093T1 HR P20230093T T HRP20230093T T HR P20230093TT HR P20230093 T HRP20230093 T HR P20230093T HR P20230093 T1 HRP20230093 T1 HR P20230093T1
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- Croatia
- Prior art keywords
- use according
- humanized antibody
- preparation
- complement
- cleavage product
- Prior art date
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- 230000000295 complement effect Effects 0.000 claims 11
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 8
- 238000003776 cleavage reaction Methods 0.000 claims 7
- 230000007017 scission Effects 0.000 claims 7
- 208000035475 disorder Diseases 0.000 claims 6
- 230000001404 mediated effect Effects 0.000 claims 6
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 208000028622 Immune thrombocytopenia Diseases 0.000 claims 2
- 208000031981 Thrombocytopenic Idiopathic Purpura Diseases 0.000 claims 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000023275 Autoimmune disease Diseases 0.000 claims 1
- 208000011038 Cold agglutinin disease Diseases 0.000 claims 1
- 206010009868 Cold type haemolytic anaemia Diseases 0.000 claims 1
- 208000035186 Hemolytic Autoimmune Anemia Diseases 0.000 claims 1
- 102000001706 Immunoglobulin Fab Fragments Human genes 0.000 claims 1
- 108010054477 Immunoglobulin Fab Fragments Proteins 0.000 claims 1
- 206010034277 Pemphigoid Diseases 0.000 claims 1
- 208000000594 bullous pemphigoid Diseases 0.000 claims 1
- 230000001804 emulsifying effect Effects 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- 238000007913 intrathecal administration Methods 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- -1 lyoprotector Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 239000003381 stabilizer Substances 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
Classifications
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- 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
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- 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
-
- 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
-
- 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
- A61P37/02—Immunomodulators
-
- 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
-
- 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
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21106—Hepsin (3.4.21.106)
-
- 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
- C07K2317/50—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
- C07K2317/70—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
-
- 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)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Transplantation (AREA)
- General Engineering & Computer Science (AREA)
- Wood Science & Technology (AREA)
- Zoology (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)
Claims (17)
1. Humanizirano protutijelo koje specifično veže komplementarnu komponentu C1s, naznačeno time što protutijelo sadrži VH regiju koja sadrži sekvencu aminokiseline prikazanu u SEQ ID NO: 14 i VL regiju koja sadrži sekvencu aminokiseline prikazanu u SEQ ID NO: 22.
2. Humanizirano protutijelo prema zahtjevu 1, naznačeno time što je humanizirano protutijelo odabrano iz skupine koju čine Fab fragment, F(ab')2 fragment, scFv, i Fv.
3. Humanizirano protutijelo prema zahtjevu 1, naznačeno time što humanizirano protutijelo sadrži konstantnu regiju teškog lanca izotipa IgG1, IgG2, IgG3, ili IgG4.
4. Pripravak koji sadrži:
a) humanizirano protutijelo prema bilo kojem od zahtjeva 1 do 3; i
b) farmaceutski prihvatljivu pomoćnu tvar.
5. Pripravak prema zahtjevu 4, naznačen time što pripravak sadrži jedno ili više od sredstva za povećanje toničnosti, sredstva za suspendiranje, sredstva za emulgiranje, stabilizator, konzervans, lioprotektor, površinski aktivnu tvar i šećer.
6. Pripravak prema zahtjevu 4 ili 5, naznačen time što je formuliran za intravensku, intramuskularnu, intratekalnu ili potkožnu primjenu.
7. Humanizirano protutijelo prema bilo kojem od zahtjeva 1 do 3, ili pripravak prema bilo kojem od zahtjeva 4 do 6 naznačen time što se koristi u liječenju bolesti ili poremećaja posredovanih komplementom.
8. Humanizirano protutijelo za upotrebu prema zahtjevu 7 ili pripravak za upotrebu prema zahtjevu 7, naznačen time što je kod pojedinca smanjena razina produkta cijepanja komponente komplementa.
9. Humanizirano protutijelo za upotrebu prema zahtjevu 8 ili pripravak za upotrebu prema zahtjevu 8, naznačen time što je produkt cijepanja komponente komplementa produkt cijepanja C4.
10. Humanizirano protutijelo za upotrebu prema zahtjevu 8 ili pripravak za upotrebu prema zahtjevu 8, naznačen time što je produkt cijepanja komponente komplementa produkt cijepanja C2.
11. Humanizirano protutijelo za upotrebu prema zahtjevu 8 ili pripravak za upotrebu prema zahtjevu 8, naznačen time što je produkt cijepanja komponente komplementa produkt cijepanja C3.
12. Humanizirano protutijelo za upotrebu prema zahtjevu 7 ili pripravak za upotrebu prema zahtjevu 7, naznačen time što je poremećaj posredovan komplementom aloimuni poremećaj.
13. Humanizirano protutijelo za upotrebu prema zahtjevu 7 ili pripravak za upotrebu prema zahtjevu 7, naznačen time što je poremećaj posredovan komplementom autoimuni poremećaj.
14. Humanizirano protutijelo za upotrebu prema zahtjevu 7 ili pripravak za upotrebu prema zahtjevu 7, naznačen time što je bolest posredovana komplementom bolest hladnih aglutinina.
15. Humanizirano protutijelo za upotrebu prema zahtjevu 7 ili pripravak za upotrebu prema zahtjevu 7, naznačen time što je poremećaj posredovan komplementom imuna trombocitopenična purpura (ITP).
16. Humanizirano protutijelo za upotrebu prema zahtjevu 7 ili pripravak za upotrebu prema zahtjevu 7, naznačen time što je poremećaj posredovan komplementom bulozni pemfigoid.
17. Humanizirano protutijelo za upotrebu prema zahtjevu 7 ili pripravak za upotrebu prema zahtjevu 7, naznačen time što se humanizirano protutijelo ili pripravak treba primijeniti intravenski, intramuskularno, intratekalno ili potkožno.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562143636P | 2015-04-06 | 2015-04-06 | |
US201562200997P | 2015-08-04 | 2015-08-04 | |
PCT/US2016/026038 WO2016164358A1 (en) | 2015-04-06 | 2016-04-05 | Humanized anti-c1s antibodies and methods of use thereof |
EP16777134.4A EP3280440B1 (en) | 2015-04-06 | 2016-04-05 | Humanized anti-c1s antibodies and methods of use thereof |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20230093T1 true HRP20230093T1 (hr) | 2023-03-31 |
Family
ID=57073330
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20230093TT HRP20230093T1 (hr) | 2015-04-06 | 2016-04-05 | Humanizirana anti-c1s protutijela i postupci njihove primjene |
Country Status (27)
Country | Link |
---|---|
US (3) | US10729767B2 (hr) |
EP (2) | EP4212175A1 (hr) |
JP (3) | JP7005483B2 (hr) |
KR (1) | KR20180006379A (hr) |
CN (2) | CN108348598B (hr) |
AU (2) | AU2016246452B2 (hr) |
BR (1) | BR112017021289A2 (hr) |
CA (1) | CA2981321A1 (hr) |
CL (1) | CL2017002514A1 (hr) |
CO (1) | CO2017011238A2 (hr) |
DK (1) | DK3280440T3 (hr) |
EA (1) | EA201792080A1 (hr) |
ES (1) | ES2938359T3 (hr) |
FI (1) | FI3280440T3 (hr) |
HK (2) | HK1250930A1 (hr) |
HR (1) | HRP20230093T1 (hr) |
HU (1) | HUE061076T2 (hr) |
IL (2) | IL254670B2 (hr) |
LT (1) | LT3280440T (hr) |
MX (2) | MX2017012834A (hr) |
PH (1) | PH12017501815A1 (hr) |
PL (1) | PL3280440T3 (hr) |
PT (1) | PT3280440T (hr) |
RS (1) | RS63956B1 (hr) |
SG (2) | SG10201909180SA (hr) |
SI (1) | SI3280440T1 (hr) |
WO (1) | WO2016164358A1 (hr) |
Families Citing this family (12)
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US11236168B2 (en) | 2012-08-24 | 2022-02-01 | Chugai Seiyaku Kabushiki Kaisha | Mouse FcγammaRII-specific Fc antibody |
AU2013334229B2 (en) | 2012-10-25 | 2018-02-15 | Bioverativ Usa Inc. | Anti-complement C1s antibodies and uses thereof |
DK2914291T3 (da) | 2012-11-02 | 2022-05-16 | Bioverativ Usa Inc | Anti-komplement-c1s-antistoffer og anvendelser deraf |
KR102318483B1 (ko) | 2013-04-02 | 2021-10-27 | 추가이 세이야쿠 가부시키가이샤 | Fc영역 개변체 |
HUE061076T2 (hu) | 2015-04-06 | 2023-05-28 | Bioverativ Usa Inc | Humanizált anti-C1s ellenanyagok alkalmazási eljárások |
MX2019004259A (es) * | 2016-10-12 | 2019-09-27 | Bioverativ Usa Inc | Anticuerpos anti-c1s y metodos de uso de los mismos. |
MX2020010528A (es) * | 2018-04-13 | 2020-11-06 | Chugai Pharmaceutical Co Ltd | Anticuerpos anti-componente de complemento y metodos de uso. |
WO2022031978A1 (en) | 2020-08-06 | 2022-02-10 | Bioverativ Usa Inc. | Inflammatory cytokines and fatigue in subject with a complement mediated disease |
CN117241828A (zh) | 2021-03-31 | 2023-12-15 | 美国比奥维拉迪维股份有限公司 | 减少冷凝集素病患者的手术相关溶血 |
US11958899B2 (en) | 2021-07-13 | 2024-04-16 | Mabwell Therapeutics Inc. | Anti-C1s antibodies and uses thereof |
WO2023245048A1 (en) | 2022-06-15 | 2023-12-21 | Bioverativ Usa Inc. | Anti-complement c1s antibody formulation |
US20240025978A1 (en) | 2022-06-24 | 2024-01-25 | Bioverativ Usa Inc. | Methods for treating complement-mediated diseases |
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