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HRP20211469T1 - Pripravak koji sadrži protutijelo koje se veže na domenu ii od her2 i njegove kiselinske varijante - Google Patents

Pripravak koji sadrži protutijelo koje se veže na domenu ii od her2 i njegove kiselinske varijante Download PDF

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Publication number
HRP20211469T1
HRP20211469T1 HRP20211469TT HRP20211469T HRP20211469T1 HR P20211469 T1 HRP20211469 T1 HR P20211469T1 HR P20211469T T HRP20211469T T HR P20211469TT HR P20211469 T HRP20211469 T HR P20211469T HR P20211469 T1 HRP20211469 T1 HR P20211469T1
Authority
HR
Croatia
Prior art keywords
preparation
variant
her2
acid variants
antibodies
Prior art date
Application number
HRP20211469TT
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English (en)
Inventor
Reed J. Harris
Paul A. Motchnik
Original Assignee
Genentech, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40672664&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20211469(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech, Inc. filed Critical Genentech, Inc.
Publication of HRP20211469T1 publication Critical patent/HRP20211469T1/hr

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Classifications

    • 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
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • 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
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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
    • C07K2317/20—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
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N2030/022—Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027—Liquid chromatography
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/416—Systems
    • G01N27/447—Systems using electrophoresis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Oncology (AREA)
  • Analytical Chemistry (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Pulmonology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Claims (18)

1. Pripravak, naznačen time, da sadrži glavne vrste protutijela HER2 koje sadrži laki lanac i teški lanac aminokiselinskih sljedova SEQ ID NO: 15 odnosno 16, i veže se na domenu II od HER2, i kiselinske varijante od tih glavnih vrsta protutijela, pri čemu su glavne vrste protutijela HER2 struktura aminokiselinskog slijeda protutijela u pripravku koja je kvantitativno nadmoćna molekula protutijela u pripravku, gdje kiselinske varijante uključuju disulfidno reduciranu varijantu.
2. Pripravak prema patentnom zahtjevu 1, naznačen time, da kiselinske varijante također uključuju glikiranu varijantu, deamidiranu varijantu, sijaliliranu varijantu i varijantu koja se ne može reducirati.
3. Pripravak prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, da je količina kiselinskih varijanti manja od 25%.
4. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da su glavne vrste protutijela HER2 i kiselinske varijante svi intaktna protutijela.
5. Pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da od glavnih vrsta protutijela sadrži varijantu s produljenjem aminoterminalnog predvodnika.
6. Pripravak prema patentnom zahtjevu 5, naznačen time, da produljenje aminoterminalnog predvodnika sadrži ili se sastoji od VHS-.
7. Farmaceutska formulacija, naznačena time, da sadrži pripravak prema bilo kojem od prethodnih patentnih zahtjeva u farmaceutski prihvatljivom nosaču.
8. Farmaceutska formulacija prema patentnom zahtjevu 7, naznačena time, da je za uporabu u postupku liječenja raka pozitivnog na HER2 kod pacijenta, pri čemu se u postupku, farmaceutska formulacija prema patentnom zahtjevu 7 daje pacijentu u količini koja je učinkovita za liječenje raka.
9. Farmaceutska formulacija za uporabu prema patentnom zahtjevu 8, naznačena time, da se u postupku farmaceutska formulacija daje u kombinaciji s trastuzumabom.
10. Farmaceutska formulacija za uporabu prema patentnom zahtjevu 8, naznačena time, da se rak bira iz skupine koja se sastoji od raka dojke, raka jajnika, raka pluća i kolorektalnog raka.
11. Farmaceutska formulacija za uporabu prema patentnom zahtjevu 8 ili 9, naznačena time, da glavne vrste protutijela i kiselinske varijante imaju bitno iste farmakokinetike.
12. Postupak proizvodnje farmaceutskog pripravka, naznačen time, da obuhvaća: (1) pripravljanje pripravka koji sadrži glavne vrste protutijela HER2 koje sadrži laki lanac i teški lanac aminokiselinskih sljedova SEQ ID NO: 15 odnosno 16, i koje se veže na domenu II od HER2, i kiselinske varijante od tih glavnih vrsta protutijela HER2 uključujući disulfidno reduciranu varijantu, pri čemu su glavne vrste protutijela HER2 struktura aminokiselinskog slijeda protutijela u pripravku koja je kvantitativno nadmoćna molekula protutijela u pripravku, i (2) evaluaciju kiselinskih varijanti u pripravku, i potvrđivanje da je njihova količina manja od oko 25%.
13. Postupak prema patentnom zahtjevu 12, naznačen time, da su u pripravku glavne vrste protutijela HER2 i kiselinske varijante svi intaktna protutijela.
14. Postupak prema patentnom zahtjevu 12 ili zahtjevu 13, naznačen time, da korak (2) obuhvaća evaluaciju kiselinskih varijanti putem nereducirane kapilarne elektroforeze s natrijevim dodecil sulfatom (CE-SDS) i detekciju disulfidno reducirane varijante.
15. Postupak prema patentnom zahtjevu 12 ili zahtjevu 13, naznačen time, da kiselinske varijante od glavnih vrsta protutijela HER2 uključuju glikiranu varijantu, deamidiranu varijantu, disulfidno reduciranu varijantu, sijaliliranu varijantu i varijantu koja se ne može reducirati.
16. Postupak prema bilo kojem od patentnih zahtjeva 12 do 15, naznačen time, da korak (2) obuhvaća evaluaciju kiselinskih varijanti putem metode koja se bira iz skupine koju čine ionska kromatografija gdje se pripravak obrađuje sa sijalidazom, reducirana kapilarna elektrofereza s natrijevim dodecil sulfatom (CE-SDS), nereducirana CE-SDS, boronatna kromatografija i peptidno mapiranje.
17. Postupak prema bilo kojem od patentnih zahtjeva 12 do 16, naznačen time, da obuhvaća miješanje pripravka nakon koraka (2) s farmaceutski prihvatljivim nosačem.
18. Postupak prema bilo kojem od patentnih zahtjeva 12 do 16, naznačen time, da se pripravak koji je evaluiran u koraku (2), nalazi u farmaceutski prihvatljivom nosaču.
HRP20211469TT 2008-01-30 2009-01-28 Pripravak koji sadrži protutijelo koje se veže na domenu ii od her2 i njegove kiselinske varijante HRP20211469T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US2482508P 2008-01-30 2008-01-30
EP18157419.5A EP3401335B1 (en) 2008-01-30 2009-01-28 Composition comprising antibody that binds to domain ii of her2 and acidic variants thereof

Publications (1)

Publication Number Publication Date
HRP20211469T1 true HRP20211469T1 (hr) 2021-12-24

Family

ID=40672664

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20211469TT HRP20211469T1 (hr) 2008-01-30 2009-01-28 Pripravak koji sadrži protutijelo koje se veže na domenu ii od her2 i njegove kiselinske varijante
HRP20180666TT HRP20180666T1 (hr) 2008-01-30 2018-04-26 Sastav koji obuhvaća protutijelo koje se veže na domenu ii od her2 i njegove kiselinske varijante

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HRP20180666TT HRP20180666T1 (hr) 2008-01-30 2018-04-26 Sastav koji obuhvaća protutijelo koje se veže na domenu ii od her2 i njegove kiselinske varijante

Country Status (37)

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US (8) US8652474B2 (hr)
EP (3) EP4119583A1 (hr)
JP (2) JP5933179B2 (hr)
KR (1) KR101223941B1 (hr)
CN (1) CN101981056B (hr)
AR (2) AR070276A1 (hr)
AU (1) AU2009210545C1 (hr)
BR (1) BRPI0905733B8 (hr)
CA (1) CA2711798C (hr)
CL (1) CL2009000178A1 (hr)
CO (1) CO6231039A2 (hr)
CR (2) CR11648A (hr)
CY (2) CY1120191T1 (hr)
DK (2) DK2238172T3 (hr)
EC (1) ECSP10010433A (hr)
ES (2) ES2668680T3 (hr)
HK (1) HK1151543A1 (hr)
HR (2) HRP20211469T1 (hr)
HU (2) HUE037471T2 (hr)
IL (2) IL206931A (hr)
LT (2) LT2238172T (hr)
MA (1) MA32099B1 (hr)
MX (1) MX2010008035A (hr)
MY (1) MY158560A (hr)
NO (1) NO2238172T3 (hr)
NZ (1) NZ586754A (hr)
PE (3) PE20091352A1 (hr)
PL (2) PL2238172T3 (hr)
PT (2) PT3401335T (hr)
RS (2) RS62085B1 (hr)
RU (3) RU2015101975A (hr)
SG (1) SG190607A1 (hr)
SI (2) SI2238172T1 (hr)
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UA (1) UA104585C2 (hr)
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