HRP20191945T1 - Poboljšana il-6-protutijela - Google Patents
Poboljšana il-6-protutijela Download PDFInfo
- Publication number
- HRP20191945T1 HRP20191945T1 HRP20191945TT HRP20191945T HRP20191945T1 HR P20191945 T1 HRP20191945 T1 HR P20191945T1 HR P20191945T T HRP20191945T T HR P20191945TT HR P20191945 T HRP20191945 T HR P20191945T HR P20191945 T1 HRP20191945 T1 HR P20191945T1
- Authority
- HR
- Croatia
- Prior art keywords
- antibody
- antigen
- binding fragment
- seq
- mutation
- Prior art date
Links
- 239000000427 antigen Substances 0.000 claims 26
- 102000036639 antigens Human genes 0.000 claims 26
- 108091007433 antigens Proteins 0.000 claims 26
- 239000012634 fragment Substances 0.000 claims 26
- 230000035772 mutation Effects 0.000 claims 11
- 102000001708 Protein Isoforms Human genes 0.000 claims 6
- 108010029485 Protein Isoforms Proteins 0.000 claims 6
- 230000009885 systemic effect Effects 0.000 claims 6
- 238000009825 accumulation Methods 0.000 claims 5
- 206010012689 Diabetic retinopathy Diseases 0.000 claims 3
- 208000003556 Dry Eye Syndromes Diseases 0.000 claims 3
- 206010012688 Diabetic retinal oedema Diseases 0.000 claims 2
- 206010013774 Dry eye Diseases 0.000 claims 2
- 108090001005 Interleukin-6 Proteins 0.000 claims 2
- 206010038848 Retinal detachment Diseases 0.000 claims 2
- 229960002833 aflibercept Drugs 0.000 claims 2
- 108010081667 aflibercept Proteins 0.000 claims 2
- 206010064930 age-related macular degeneration Diseases 0.000 claims 2
- 201000011190 diabetic macular edema Diseases 0.000 claims 2
- 208000002780 macular degeneration Diseases 0.000 claims 2
- 150000007523 nucleic acids Chemical class 0.000 claims 2
- 102000039446 nucleic acids Human genes 0.000 claims 2
- 108020004707 nucleic acids Proteins 0.000 claims 2
- 201000007914 proliferative diabetic retinopathy Diseases 0.000 claims 2
- 208000019793 rhegmatogenous retinal detachment Diseases 0.000 claims 2
- 229960003989 tocilizumab Drugs 0.000 claims 2
- 206010010744 Conjunctivitis allergic Diseases 0.000 claims 1
- 208000028006 Corneal injury Diseases 0.000 claims 1
- 206010046851 Uveitis Diseases 0.000 claims 1
- 208000027418 Wounds and injury Diseases 0.000 claims 1
- 208000002205 allergic conjunctivitis Diseases 0.000 claims 1
- 208000024998 atopic conjunctivitis Diseases 0.000 claims 1
- 230000006378 damage Effects 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 208000030533 eye disease Diseases 0.000 claims 1
- 208000014674 injury Diseases 0.000 claims 1
- 230000014759 maintenance of location Effects 0.000 claims 1
- 208000008795 neuromyelitis optica Diseases 0.000 claims 1
- 208000004644 retinal vein occlusion Diseases 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
- C07K16/248—IL-6
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- 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
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- 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
- 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
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- 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
- C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
-
- 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
- C07K2317/71—Decreased effector function due to an Fc-modification
-
- 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
-
- 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
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Ophthalmology & Optometry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Epidemiology (AREA)
- Hematology (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Obesity (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (21)
1. Protutijelo ili fragment koji veže antigen, naznačeno time, da obuhvaća varijabilno područje teškog lanca koje sadrži SEQ ID NO:37 i varijabilno područje lakog lanca koje sadrži SEQ ID NO:38.
2. Protutijelo ili fragment koji veže antigen, naznačeno time, da obuhvaća sekvencu teškog lanca koja sadrži SEQ ID NO:41 i sekvencu lakog lanca koja sadrži SEQ ID NO:42; ili time, da protutijelo ili fragment koji veže antigen i koji obuhvaća sekvencu teškog lanca koja sadrži SEQ ID NO:41 i sekvencu lakog lanca koja sadrži SEQ ID NO:42, obuhvaća mutaciju (npr. 1, 2, 3 ili 4 mutacije) na jednoj ili više pozicija koje odgovaraju sljedećima: H311, D313, I254 ili H436 (numeriranje je kao u SEQ ID NO:41).
3. Fab, naznačen time, da obuhvaća sekvencu teškog lanca koja sadrži SEQ ID NO:39 ili SEQ ID NO:54 i sekvencu lakog lanca koja sadrži SEQ ID NO:42.
4. Protutijelo ili fragment koji veže antigen prema patentnom zahtjevu 1, naznačeno time, da protutijelo ili fragment koji veže antigen ima poboljšano zadržavanje u oku kada se primjenjuje intravitrealno, u usporedbi s tocilizumabom i/ili afliberceptom.
5. Protutijelo ili fragment koji veže antigen prema bilo kojem od patentnih zahtjeva 1 i 4, naznačeno time, da protutijelo ili fragment koji veže antigen obuhvaća mutaciju (npr. 1, 2, 3 ili 4 mutacije) na jednoj ili više pozicija koje odgovaraju sljedećima: H311, D313, I254 ili H436 (numeriranje je kao u SEQ ID NO:41).
6. Protutijelo ili fragment koji veže antigen prema patentnom zahtjevu 2 ili 5, naznačeno time, da je navedena mutacija odabrana od jedne ili više od sljedećih: H311A, H311E, H311N, D313T, I254A, I254R i H436A.
7. Protutijelo ili fragment koji veže antigen prema bilo kojem od patentnih zahtjeva 2 i 5 do 6, naznačeno time, da navedena mutacija je H311A mutacija (numeriranje je kao u SEQ ID NO:41).
8. Protutijelo ili fragment koji veže antigen prema bilo kojem od patentnih zahtjeva 2 i 5 do 7, naznačeno time, da navedena mutacija smanjuje sistemsku akumulaciju protutijela ili fragmenta koji veže antigen, u usporedbi sa sistemskom akumulacijom protutijela ili fragmenta koji veže antigen, koji ne sadrži mutaciju.
9. Protutijelo ili fragment koji veže antigen prema bilo kojem od patentnih zahtjeva 2 i 5 do 7, naznačeno time, da navedena mutacija smanjuje sistemsku akumulaciju protutijela ili fragmenta koji veže antigen, u usporedbi sa sistemskom akumulacijom protutijela ili fragmenta koji veže antigen, koji ne sadrži mutaciju, gdje se sistemska akumulacija procjenjuje nakon intravitrealne primjene protutijela ili fragmenta koji veže antigen.
10. Protutijelo ili fragment koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 9, naznačeno time, da protutijelo ili fragment koji veže antigen ima sistemski poluživot koji je kraći nego što je to kod tocilizumaba i/ili aflibercepta.
11. Protutijelo ili fragment koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 10, naznačeno time, da protutijelo ili fragment koji veže antigen je izoform IgG2-A ili izoform IgG2-A/B, ali nije izoform IgG2-B.
12. Protutijelo ili fragment koji veže antigen, naznačeno time, da obuhvaća sekvencu teškog lanca koja sadrži SEQ ID NO:47 i sekvencu lakog lanca koja sadrži SEQ ID NO:42.
13. Pripravak, naznačen time, da obuhvaća protutijelo ili fragment koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 12 i prema potrebi, farmaceutski prihvatljiv nosač.
14. Pripravak prema patentnom zahtjevu 13, naznačen time, da pripravak obuhvaća najmanje 60, 70, 80, 90, 95 ili 99% od izoforma IgG2-A protutijela ili izoforma IgG2-A/B protutijela, ili od njihove kombinacije.
15. Pripravak prema patentnom zahtjevu 13 ili 14, naznačen time, da pripravak obuhvaća manje od 10%, 5%, 2%, 1% ili 0,5% od izoforma IgG2-B protutijela.
16. Pripravak prema bilo kojem od patentnih zahtjeva 13 do 15, ili protutijelo ili fragment koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 12, naznačeni time, da se upotrebljavaju u liječenju bolesti povezane s IL-6.
17. Pripravak za uporabu prema patentnom zahtjevu 16, ili protutijelo ili fragment koji veže antigen za uporabu prema patentnom zahtjevu 16, naznačeni time, da se upotrebljavaju u liječenju očne bolesti koja je karakteristična po povišenoj razini IL-6.
18. Pripravak prema bilo kojem od patentnih zahtjeva 13 do 15, ili protutijelo ili fragment koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 12, naznačeni time, da se upotrebljavaju u liječenju dijabetičkog makularnog edema (DME), dijabetičke retinopatije, suhih očiju (npr. bolest suhog oka ili sindrom suhog oka), alergijskog konjunktivitisa, uveitisa, makularne degeneracije vezane uz dob (AMD), proliferativne dijabetičke retinopatije (PDR), regmatogene retinalne ablacije (RRA), okluzije retinalne vene (ORV), optičkog neuromijelitisa (ONM), transplantacije rožnice, abrazije rožnice, ili fizičke ozljede oka.
19. Nukleinska kiselina, naznačena time, da ona obuhvaća sekvencu koja kodira protutijelo ili fragment koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 12.
20. Vektor, naznačen time, da on obuhvaća nukleinsku kiselinu prema patentnom zahtjevu 19.
21. Stanica, naznačena time, da ona obuhvaća vektor prema patentnom zahtjevu 20.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462077105P | 2014-11-07 | 2014-11-07 | |
US201462087448P | 2014-12-04 | 2014-12-04 | |
US201562247705P | 2015-10-28 | 2015-10-28 | |
EP15797538.4A EP3215530B9 (en) | 2014-11-07 | 2015-11-06 | Improved il-6 antibodies |
PCT/US2015/059532 WO2016073890A1 (en) | 2014-11-07 | 2015-11-06 | Improved il-6 antibodies |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20191945T1 true HRP20191945T1 (hr) | 2020-01-24 |
Family
ID=54602042
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20191945TT HRP20191945T1 (hr) | 2014-11-07 | 2019-10-25 | Poboljšana il-6-protutijela |
Country Status (33)
Country | Link |
---|---|
US (2) | US11142571B2 (hr) |
EP (3) | EP3215530B9 (hr) |
JP (1) | JP6594438B2 (hr) |
KR (2) | KR20240023450A (hr) |
CN (1) | CN107249631B (hr) |
AU (1) | AU2015342882B2 (hr) |
BR (1) | BR112017008672A2 (hr) |
CA (1) | CA2965689C (hr) |
CL (1) | CL2017001135A1 (hr) |
CO (1) | CO2017005404A2 (hr) |
CR (1) | CR20170231A (hr) |
DK (1) | DK3215530T3 (hr) |
EA (1) | EA035199B1 (hr) |
ES (1) | ES2756275T3 (hr) |
HK (1) | HK1244008A1 (hr) |
HR (1) | HRP20191945T1 (hr) |
HU (1) | HUE046181T2 (hr) |
IL (1) | IL251858B (hr) |
MA (1) | MA51554A (hr) |
MX (2) | MX2017005992A (hr) |
MY (1) | MY185114A (hr) |
NZ (1) | NZ731090A (hr) |
PE (1) | PE20171107A1 (hr) |
PH (1) | PH12017500809A1 (hr) |
PL (1) | PL3215530T3 (hr) |
PT (1) | PT3215530T (hr) |
RS (1) | RS59805B1 (hr) |
SA (1) | SA517381458B1 (hr) |
SG (2) | SG11201703574VA (hr) |
SI (1) | SI3215530T1 (hr) |
UA (1) | UA122673C2 (hr) |
WO (1) | WO2016073890A1 (hr) |
ZA (1) | ZA201702985B (hr) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SG10201911226QA (en) | 2015-09-23 | 2020-01-30 | Genentech Inc | Optimized variants of anti-vegf antibodies |
CN108718522A (zh) * | 2016-02-23 | 2018-10-30 | 赛森生物股份有限公司 | Il-6拮抗剂制剂及其用途 |
JP2020504105A (ja) * | 2016-12-19 | 2020-02-06 | グレンマーク・ファーマシューティカルズ・エスエー | 新規なtnfrアゴニストおよびその使用 |
CA3056248A1 (en) | 2017-03-22 | 2018-09-27 | Genentech, Inc. | Optimized antibody compositions for treatment of ocular disorders |
AU2018240375C1 (en) | 2017-03-22 | 2024-02-01 | Ascendis Pharma A/S | Hydrogel cross-linked hyaluronic acid prodrug compositions and methods |
CN109867723B (zh) * | 2017-12-05 | 2022-06-17 | 南京金斯瑞生物科技有限公司 | 抗人il6单克隆抗体及其制备方法和用途 |
IL296256A (en) | 2020-03-13 | 2022-11-01 | Genentech Inc | Antibodies against interleukin-33 and uses thereof |
TW202144419A (zh) | 2020-03-24 | 2021-12-01 | 美商建南德克公司 | Tie2結合劑及其使用方法 |
TW202228790A (zh) | 2020-10-15 | 2022-08-01 | 美商建南德克公司 | 用於長效經眼遞送之非共價蛋白質-玻尿酸結合物 |
CN116554298A (zh) * | 2022-02-25 | 2023-08-08 | 南京工业大学 | 一种强化细菌卷曲菌毛提高人表皮生长因子分泌生产效率的方法 |
WO2024088921A1 (en) * | 2022-10-24 | 2024-05-02 | F. Hoffmann-La Roche Ag | Predicting response to il-6 antagonists |
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