HRP20210736T1 - Protutijela anti-htra1 i načini njihove uporabe - Google Patents

Protutijela anti-htra1 i načini njihove uporabe Download PDF

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Publication number
HRP20210736T1
HRP20210736T1 HRP20210736TT HRP20210736T HRP20210736T1 HR P20210736 T1 HRP20210736 T1 HR P20210736T1 HR P20210736T T HRP20210736T T HR P20210736TT HR P20210736 T HRP20210736 T HR P20210736T HR P20210736 T1 HRP20210736 T1 HR P20210736T1
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HR
Croatia
Prior art keywords
antibody
factor
use according
htra1
fab
Prior art date
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HRP20210736TT
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English (en)
Inventor
Robert F. Kelley
Daniel K. Kirchhoffer
Joyce LAI
Chingwei V. Lee
Wei-Ching Liang
Michael T. Lipari
Kelly M. Loyett
Tao Sai
Menno Van Lookeren-Campagne
Yan Wu
Germaine Fuh
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F. Hoffmann - La Roche Ag
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Application filed by F. Hoffmann - La Roche Ag filed Critical F. Hoffmann - La Roche Ag
Publication of HRP20210736T1 publication Critical patent/HRP20210736T1/hr

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    • 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
    • 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
    • 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
    • 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
    • A61K9/0051—Ocular inserts, ocular implants
    • 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
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • 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
    • C07K2317/34—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
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Ophthalmology & Optometry (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Endocrinology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Plant Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (27)

1. Izolirano monoklonsko, humanizirano protutijelo koje se specifično veže za HtrA1, naznačeno time, da protutijelo obuhvaća varijabilnu domenu teškog lanca (VH) koja se sastoji od slijeda aminokiselina SEQ ID No.: 21 i varijabilnu domenu lakog lanca (VL) koja se sastoji od slijeda aminokiselina SEQ ID No.: 22.
2. Protutijelo prema patentnom zahtjevu 1, naznačeno time, da je protutijelo fragment protutijela koji se veže za HtrA1.
3. Protutijelo prema patentnom zahtjevu 2, naznačeno time, da je protutijelo fragment protutijela odabran iz skupine koja se sastoji od fragmenata Fab, Fab’-SH, Fv, scFV i (Fab’)2.
4. Protutijelo prema patentnom zahtjevu 2, naznačeno time, da je fragment protutijela Fab.
5. Protutijelo prema patentnom zahtjevu 4, naznačeno time, da Fab uključuje skraćenje u gornjem zglobu konstantne regije teškog lanca.
6. Protutijelo prema patentnom zahtjevu 5, naznačeno time, da konstantna regija teškog lanca završava na položaju 221 (EU numeriranje).
7. Protutijelo prema bilo kojem patentnom zahtjevu od 2 do 6, naznačeno time, da protutijelo obuhvaća slijed aminokiselina teškog lanca SEQ ID No.: 160.
8. Protutijelo prema bilo kojem patentnom zahtjevu od 2 do 7, naznačeno time, da protutijelo obuhvaća sekvencu aminokiseline lakog lanca SEQ ID No.: 159.
9. Protutijelo prema bilo kojem patentnom zahtjevu od 1 do 8, naznačeno time, da protutijelo bispecifično protutijelo.
10. Izolirana nukleinska kiselina koja kodira protutijelo prema bilo kojem patentnom zahtjevu od 1 do 9.
11. Postupak proizvodnje protutijela, naznačen time, da postupak obuhvaća uzgoj stanice domaćina koja sadrži vektor koji sadrži izoliranu nukleinsku kiselinu prema patentnom zahtjevu 10 i izdvajanje protutijela iz stanice domaćina ili medija za uzgoj stanice domaćina.
12. Farmaceutski pripravak koji obuhvaća protutijelo prema bilo kojem patentnom zahtjevu od 1 do 9 i dodatno sadrži najmanje jedan farmaceutski prihvatljivi nosač, ekscipijens ili razrjeđivač.
13. Farmaceutski pripravak prema patentnom zahtjevu 12, naznačen time, da je pripravak liofiliziran.
14. Terapeutska formulacija koja sadrži protutijelo prema bilo kojem patentnom zahtjevu od 1 do 9 i antagonist faktora D, naznačena time, da je antagonist faktora D protutijelo anti-faktora D.
15. Terapeutska formulacija prema patentnom zahtjevu 14, naznačena time, da je protutijelo anti-faktora D lampalizumab.
16. Protutijelo prema bilo kojem patentnom zahtjevu od 1 do 9, naznačeno time, da se upotrebljava kao lijek.
17. Protutijelo prema bilo kojem patentnom zahtjevu od 1 do 9, za uporabu u liječenju poremećaja povezanih s HtrA1 ili očnog poremećaja, naznačeno time, da je poremećaj povezan s HtrA1 starosnom makularnom degeneracijom (AMD), dijabetičkom retinopatijom, retinopatijom nedonoščadi ili polipoidnom koroidalnom vaskulopatijom.
18. Protutijelo za uporabu prema patentnom zahtjevu 17, naznačeno time, da je poremećaj povezan s HtrA1 ili očni poremećaj starosna makularna degeneracija (AMD), dijabetička retinopatija, retinopatija nedonoščadi ili polipoidna koroidalna vaskulopatija.
19. Protutijelo za uporabu prema patentnom zahtjevu 17 ili 18, naznačeno time, da je poremećaj povezan s HtrA1 ili očni poremećaj rani suhi AMD, srednje suhi AMD ili uznapredovali suhi AMD.
20. Protutijelo za uporabu prema patentnom zahtjevu 19, naznačeno time, da je uznapredovali suhi AMD geografska atrofija.
21. Protutijelo za uporabu prema bilo kojem patentnom zahtjevu od 16 do 20, naznačeno time, da je protutijelo formulirano za primjenu s antagonistom faktora D, pri čemu je antagonist faktora D protutijelo anti-faktora D.
22. Protutijelo za uporabu prema patentnom zahtjevu 21, naznačeno time, da se protutijelo anti-faktora D daje sekvencijalno.
23. Protutijelo za uporabu prema patentnom zahtjevu 21, naznačeno time, da je protutijelo anti-faktora D lampalizumab.
24. Protutijelo za uporabu prema bilo kojem patentnom zahtjevu od 17 do 23, naznačeno time, da se protutijelo daje intravitrealno, okularno, intraokularno, jukstaskleralno, subtenonski, superkoroidno ili lokalno.
25. Protutijelo za uporabu prema patentnom zahtjevu 24, naznačeno time, da se protutijelo daje intravitrealno injekcijom.
26. Protutijelo za uporabu prema bilo kojem patentnom zahtjevu od 17 do 24, naznačeno time, da se protutijelo daje dugodjelujućim sustavom primjene.
27. Protutijelo za uporabu prema patentnom zahtjevu 26, naznačeno time, da je dugodjelujući sustav primjene kruti implantat na bazi PLGA ili sustav primjene s implantabilnim priključkom.
HRP20210736TT 2015-10-30 2021-05-11 Protutijela anti-htra1 i načini njihove uporabe HRP20210736T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562248871P 2015-10-30 2015-10-30
US201662345669P 2016-06-03 2016-06-03
US201662411113P 2016-10-21 2016-10-21
PCT/US2016/059110 WO2017075212A1 (en) 2015-10-30 2016-10-27 Anti-htra1 antibodies and methods of use thereof
EP16794157.4A EP3368578B1 (en) 2015-10-30 2016-10-27 Anti-htra1 antibodies and methods of use thereof

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HRP20210736T1 true HRP20210736T1 (hr) 2021-06-11

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US (5) US10421821B2 (hr)
EP (2) EP3922649B1 (hr)
JP (2) JP6750010B2 (hr)
KR (2) KR102440160B1 (hr)
CN (2) CN108290957B (hr)
AU (2) AU2016344399B2 (hr)
BR (1) BR112018007703A2 (hr)
CA (2) CA3001362C (hr)
CL (3) CL2018001139A1 (hr)
CO (1) CO2018005393A2 (hr)
CR (1) CR20180296A (hr)
DK (1) DK3368578T3 (hr)
ES (1) ES2870141T3 (hr)
HK (1) HK1256094A1 (hr)
HR (1) HRP20210736T1 (hr)
HU (1) HUE054093T2 (hr)
IL (3) IL295097A (hr)
LT (1) LT3368578T (hr)
MA (1) MA43113B1 (hr)
MX (2) MX2018004509A (hr)
MY (1) MY196448A (hr)
NZ (1) NZ741780A (hr)
PE (1) PE20181009A1 (hr)
PH (1) PH12018500887A1 (hr)
PL (1) PL3368578T3 (hr)
PT (1) PT3368578T (hr)
RS (1) RS61871B1 (hr)
RU (2) RU2750285C2 (hr)
SG (2) SG11201803356SA (hr)
SI (1) SI3368578T1 (hr)
TW (2) TWI747850B (hr)
UA (1) UA123773C2 (hr)
WO (1) WO2017075212A1 (hr)
ZA (2) ZA201802382B (hr)

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CA3001362C (en) 2015-10-30 2020-10-13 Genentech, Inc. Anti-htra1 antibodies and methods of use thereof
JP7164521B2 (ja) 2016-06-21 2022-11-01 オリオン・オフサルモロジー・エルエルシー 炭素環式プロリンアミド誘導体
CN114685453A (zh) 2016-06-21 2022-07-01 奥瑞恩眼科有限责任公司 杂环脯氨酰胺衍生物
CN109415732B (zh) 2016-07-01 2024-01-02 豪夫迈·罗氏有限公司 用于调节htra1表达的反义寡核苷酸
CA3085211A1 (en) 2017-12-21 2019-06-27 F. Hoffmann-La Roche Ag Companion diagnostic for htra1 rna antagonists
TW202039585A (zh) * 2018-11-16 2020-11-01 美商雙子治療公司 靶向htra1之基於抗體之療法及使用方法
US20230312729A1 (en) * 2019-06-26 2023-10-05 Amunix Pharmaceuticals, Inc. Egfr antigen binding fragments and compositions comprising same
IL296256A (en) 2020-03-13 2022-11-01 Genentech Inc Antibodies against interleukin-33 and uses thereof
CN118339187A (zh) * 2021-12-31 2024-07-12 上海宏成药业有限公司 抗pd-1抗体及其用途

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