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FI4268843T3 - Parannettuja il-6-vasta-aineita - Google Patents

Parannettuja il-6-vasta-aineita

Info

Publication number
FI4268843T3
FI4268843T3 FIEP23189385.0T FI23189385T FI4268843T3 FI 4268843 T3 FI4268843 T3 FI 4268843T3 FI 23189385 T FI23189385 T FI 23189385T FI 4268843 T3 FI4268843 T3 FI 4268843T3
Authority
FI
Finland
Prior art keywords
seq
sequence
antibody
heavy chain
light chain
Prior art date
Application number
FIEP23189385.0T
Other languages
English (en)
Inventor
Michael March Schmidt
Alison Tisdale
Eric Steven Furfine
Grigorios Zarbis-Papastoitsis
Original Assignee
F Hoffmann La Roche Ltd
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.)
Filing date
Publication date
Application filed by F Hoffmann La Roche Ltd filed Critical F Hoffmann La Roche Ltd
Application granted granted Critical
Publication of FI4268843T3 publication Critical patent/FI4268843T3/fi

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • C07K16/248IL-6
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71Decreased effector function due to an Fc-modification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Mycology (AREA)
  • Microbiology (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 (14)

PATENTTIVAATIMUKSET
1. Anti-IL6-vasta-aine, joka käsittää (a) raskasketjun CDR1:n, joka käsittää sekvenssin GYVLPNYLIE (SEO ID NO:31), (b) raskasketjun CDR2:n, joka käsittää sekvenssin VTTPGGGTIN (SEQ ID NO:32), (c) raskasketjun CDR3:n, joka käsittää sekvenssin SRWDPLYYYALEY (SEO ID NO:33), (d) kevytketjun CDR1:n, joka käsittää sekvenssin RASESVDNYGIPFMN (SEQ ID NO:34), (e) kevytketjun CDR2:n, joka käsittää sekvenssin AASNRGS (SEQ ID NO:35) ja (f) kevytketjun CDR3:n, joka käsittää sekvenssin QQSEEVPLT (SEO ID NO:36).
2. Anti-IL6-vasta-aine, joka käsittää sekvenssin SEO ID NO:37 käsittävän raskasketjun vaihtelevan alueen ja sekvenssin SEO ID NO:38 käsittävän kevytketjun vaihtelevan alueen sillä poikkeuksella, että anti-IL6-vasta-aineessa on — yhteensä 1, 2 tai 3 mutaatiota, ja jossa raskasketjun vaihteleva alue käsittää aminohapposekvenssit GYVLPNYLIE (SEQ ID NO:31), VTTPGGGTIN (SEO ID NO:32) ja SRWDPLYYYALEY (SEQ ID NO: 33) ja jossa kevytketjun vaihteleva alue käsittää aminohapposekvenssit RASESVDNYGIPFMN (SEO ID NO:34), AASNRGS (SEO ID NO:35) ja QQSEEVPLT (SEQ ID NO:36).
3. Anti-IL6-vasta-aine, joka käsittää sekvenssin SEO ID NO:41 kanssa identtisen raskasketjun sekvenssin ja sekvenssin SEO ID NO:42 kanssa identtisen kevytketjusekvenssin sillä poikkeuksella, että vasta-aine käsittää yhteensä 1, 2, 3, 4 tai 5 mutaatiota suhteessa sekvenssiin SEO ID NO:41 ja/tai sekvenssiin SEO ID NO:42, ja jossa raskasketjun vaihteleva alue käsittää aminohapposekvenssit — GYVLPNYLIE (SEQ ID NO:31), VTTPGGGTIN (SEQ ID NO:32) ja SRWDPLYYYALEY (SEQ ID NO:33) ja jossa kevytketjun vaihteleva alue käsittää aminohapposekvenssit RASESVDNYGIPFMN (SEO ID NO:34), AASNRGS (SEO ID NO:35) ja QQSEEVPLT (SEQ ID NO:36).
4. Patenttivaatimuksen 2 mukainen anti-IL6-vasta-aine, jossa 1, 2, 3, 4 tai 5 mutaatio(ta) vähentää/vähentävät FcRn:n sitoutumista.
5. Patenttivaatimuksen 2 mukainen anti-IL6-vasta-aine, jossa yksi tai useampi — mutaatioista on yhdessä tai useammassa H311:tä, D313:a, 1254:44 tai H436:ta vastaavassa asemassa (numerointi sekvenssin SEO ID NO:41 mukainen).
6. Anti-IL6-vasta-aine, joka käsittää sekvenssin SEO ID NO:47 kanssa identtisen raskasketjun sekvenssin ja sekvenssin SEO ID NO:42 kanssa identtisen kevytketjun sekvenssin sillä poikkeuksella, että anti-IL6-vasta-aine käsittää — yhteensä 1, 2, 3, 4 tai 5 mutaatiota suhteessa sekvenssiin SEO ID NO:47 ja/tai sekvenssiin SEO ID NO:42 ja se käsittää raskasketjun CDR-aminohapposekvenssit GYVLPNYLIE (SEQ ID NO:31), VTTPGGGTIN (SEO ID NO:32), ja SRWDPLYYYALEY (SEQ ID NO:33) ja kevytketjun CDR-aminohapposekvenssit RASESVDNYGIPFMN (SEO ID NO:34) AASNRGS (SEO ID NO:35) ja — QQSEEVPLT (SEQ ID NO: 36).
7. Koostumus, joka käsittää jonkin patenttivaatimuksista 1-6 mukaista anti- IL6-vasta-ainetta ja valinnaisesti farmaseuttisesti hyväksyttävää kantajaa.
8. Patenttivaatimuksen 7 mukainen koostumus, jossa koostumus käsittää vähintään 60, 70, 80, 90, 95 tai 99 % anti-IL6-vasta-aineen IgG2-A- tai IgG2-A/B- — isoformeja tai niiden yhdistelmää.
9. Patenttivaatimuksen 7 tai 8 mukainen koostumus, jossa koostumus käsittää alle 10 %, 5 %, 2 %, 1 % tai 0,5 % anti-IL6-vasta-aineen IgG2-B-isoformeja.
10. — Jonkin patenttivaatimuksista 1-6 mukainen anti-IL6-vasta-aine tai jonkin patenttivaatimuksista 6-9 mukainen koostumus käytettäväksi — sellaisen — silmäsairauden hoidossa, jota karakterisoi kohonnut IL-6-taso.
11. — Jonkin patenttivaatimuksista 1-6 mukainen anti-IL6-vasta-aine tai jonkin patenttivaatimuksista 6-9 mukainen koostumus käytettäväksi yhden seuraavista hoidossa: diabeettinen makulaturvotus (DME), diabeettinen retinopatia, silmien kuivuminen (esim. kuivasilmäisyys tai kuivasilmäisyysoireyhtymä), allerginen — sidekalvotulehdus, suonikalvoston tulehdus, ikään liittyvä makularappeuma (AMD), — proliferatiivinen — diabeettinen — retinopatia (PDR), reumaattinen verkkokalvon irtauma (RRD), verkkokalvon laskimotukos (RVO), neuromyelitis optica (NMO), sarveiskalvosiirre, sarveiskalvon kuluma tai silmän fyysinen vamma.
12. Nukleiinihappo, joka käsittää jonkin patenttivaatimuksista 1-6 mukaista anti-IL6-vasta-ainetta koodittavan sekvenssin.
13. Vektori, joka käsittää patenttivaatimuksen 12 mukaisen nukleiinihapon.
14 Solu, joka käsittää patenttivaatimuksen 13 mukaisen vektorin.
FIEP23189385.0T 2014-11-07 2015-11-06 Parannettuja il-6-vasta-aineita FI4268843T3 (fi)

Applications Claiming Priority (3)

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

Publications (1)

Publication Number Publication Date
FI4268843T3 true FI4268843T3 (fi) 2025-11-14

Family

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FIEP23189385.0T FI4268843T3 (fi) 2014-11-07 2015-11-06 Parannettuja il-6-vasta-aineita

Country Status (32)

Country Link
US (3) US11142571B2 (fi)
EP (3) EP3632931A1 (fi)
JP (1) JP6594438B2 (fi)
KR (2) KR102636726B1 (fi)
CN (1) CN107249631B (fi)
AU (1) AU2015342882B2 (fi)
CA (1) CA2965689C (fi)
CL (1) CL2017001135A1 (fi)
CO (1) CO2017005404A2 (fi)
CR (1) CR20170231A (fi)
DK (2) DK4268843T3 (fi)
EA (1) EA035199B1 (fi)
ES (1) ES2756275T3 (fi)
FI (1) FI4268843T3 (fi)
HR (1) HRP20191945T1 (fi)
HU (1) HUE046181T2 (fi)
IL (1) IL251858B (fi)
LT (1) LT4268843T (fi)
MA (1) MA51554A (fi)
MX (2) MX385206B (fi)
MY (1) MY185114A (fi)
PE (1) PE20171107A1 (fi)
PH (1) PH12017500809B1 (fi)
PL (1) PL3215530T3 (fi)
PT (2) PT3215530T (fi)
RS (1) RS59805B1 (fi)
SA (1) SA517381458B1 (fi)
SG (2) SG10202103420PA (fi)
SI (1) SI3215530T1 (fi)
UA (1) UA122673C2 (fi)
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