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HRP20240924T1 - Anti - sirpalpha antitijela - Google Patents

Anti - sirpalpha antitijela Download PDF

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Publication number
HRP20240924T1
HRP20240924T1 HRP20240924TT HRP20240924T HRP20240924T1 HR P20240924 T1 HRP20240924 T1 HR P20240924T1 HR P20240924T T HRP20240924T T HR P20240924TT HR P20240924 T HRP20240924 T HR P20240924T HR P20240924 T1 HRP20240924 T1 HR P20240924T1
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HR
Croatia
Prior art keywords
amino acid
acid sequence
sirpα antibody
sequence seq
antibody
Prior art date
Application number
HRP20240924TT
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English (en)
Inventor
Gijsbertus Franciscus Maria Verheijden
Gerard Rouwendal
Roland Jan ARENDS
Timo Kars Van Den Berg
Hanke Lottie MATLUNG
Katarina FRANKE
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Byondis B.V.
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Application filed by Byondis B.V. filed Critical Byondis B.V.
Publication of HRP20240924T1 publication Critical patent/HRP20240924T1/hr

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    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896Immunoglobulins [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
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • 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
    • C07K2317/72Increased 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
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
    • 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

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

Claims (15)

1. Anti-SIRPα protutijelo ili njegov fragment koji veže antigen, koji sadrži varijabilnu regiju (VR) teškog lanca (HC) i lakog lanca (LC) koja određuje komplementarnost (CDR) CDR1, CDR2 i CDR3, pri čemu: a. HC VR CDR1 sastoji se od aminokiselinske sekvence HGIS, b. HC VR CDR2 sastoji se od aminokiselinske sekvence TIGTGVITYFASWAKG, c. HC VR CDR3 sastoji se od aminokiselinske sekvence GSAWNDPFDP, d. LC VR CDR1 sastoji se od aminokiselinske sekvence QASQSVYGNNDLA, e. LC VR CDR2 sastoji se od aminokiselinske sekvence LASTLAT, tj f. LC VR CDR3 sastoji se od aminokiselinske sekvence LGGGDDEADNV gdje su CDR-ovi označeni prema Kabatovoj numeraciji.
2. Anti-SIRPα antitijelo ili njegov antigen-vezujući fragment sukladno zahtjevu 1, naznačeno time da je kimerno, humanizirano ili humano.
3. Anti-SIRPα antitijelo ili njegov antigen-vezujući fragment sukladno zahtjevu 2, naznačeno time da je humanizirano.
4. Humanizirano anti-SIRPα protutijelo ili njegov fragment koji veže antigen sukladno zahtjevu 3, naznačeno time što sadrži a. HC VR aminokiselinska sekvenca SEQ ID NO:35 i LC VR aminokiselinska sekvenca SEQ ID NO:36; b. HC VR aminokiselinska sekvenca SEQ ID NO:35 i LC VR aminokiselinska sekvenca SEQ ID NO:37; c. HC VR aminokiselinska sekvenca SEQ ID NO:13 i LC VR aminokiselinska sekvenca SEQ ID NO:38; ili d. HC VR aminokiselinska sekvenca SEQ ID NO:13 i LC VR aminokiselinska sekvenca SEQ ID NO:37.
5. Anti-SIRPα antitijelo sukladno bilo kojem od zahtjeva 1 do 4, koje sadrži modificiranu Fc regiju koja pokazuje smanjeno vezanje na ljudski Fca ili Fcy receptor u usporedbi s istim anti-SIRPα antitijelom koja sadrži Fc regiju divljeg tipa.
6. Anti-SIRPα protutijelo sukladno zahtjevu 5, koje sadrži modificiranu ljudsku IgGi Fc regiju koja sadrži aminokiselinske supstitucije na jednom ili više položaja odabranih iz skupine koju čine L234, L235, G237, D265, D270, N297, A327, P328 , i P329 prema EU numeraciji.
7. Anti-SIRPα protutijelo sukladno zahtjevu 6, naznačeno time da sadrži aminokiselinske supstitucije L234A i L235A; L234E i L235A; L234A, L235A i P329A; ili L234A, L235A i P329G.
8. Anti-SIRPα protutijelo sukladno zahtjevu 7, naznačeno time da sadrži aminokiselinske supstitucije L234A i L235A; ili L234E i L235A.
9. Farmaceutski pripravak, naznačen time, da sadrži anti-SIRPα antitijelo sukladno bilo kojem od zahtjeva 1 do 8 i jedan ili više farmaceutski prihvatljivih ekscipijenata.
10. Anti-SIRPα antitijelo sukladno bilo kojem od zahtjeva 1 do 8 ili farmaceutski pripravak sukladno zahtjevu 9 za upotrebu kao lijek.
11. Anti-SIRPα antitijelo sukladno bilo kojem od zahtjeva 1 do 8 ili farmaceutski pripravak sukladno zahtjevu 9 za upotrebu u liječenju humanih solidnih tumora ili hematoloških zloćudnih bolesti.
12. Kombinacija anti-SIRPα protutijela sukladno bilo kojem od zahtjeva 1 do 8 ili farmaceutskog pripravka sukladno zahtjevu 9 s jednim ili više drugih terapeutika protiv raka za upotrebu u liječenju humanih solidnih tumora ili hematoloških zloćudnih bolesti.
13. Kombinacija za upotrebu sukladno zahtjevu 12, naznačena time što su jedan ili više drugih terapeutika protiv raka ciljani terapeutici ili imunoterapijski agensi.
14. Kombinacija za upotrebu sukladno zahtjevu 13, naznačena time što je ciljani terapeutik terapeutsko protutijelo ili konjugat protutijelo-lijek.
15. Kombinacija za upotrebu sukladno zahtjevu 14, naznačena time što je terapijsko protutijelo terapijsko protutijelo protiv cilja vezanog na membranu na površini tumorskih stanica koje sadrže ljudsku Fc regiju koja se veže na aktiviranje Fc receptora prisutnih na ljudskim imunološkim efektorskim stanicama .
HRP20240924TT 2017-05-16 2018-05-15 Anti - sirpalpha antitijela HRP20240924T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17171285 2017-05-16
EP18729328.7A EP3625259B1 (en) 2017-05-16 2018-05-15 Anti-sirpalpha antibodies
PCT/EP2018/062473 WO2018210793A2 (en) 2017-05-16 2018-05-15 ANTI-SIRPα ANTIBODIES

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HRP20240924T1 true HRP20240924T1 (hr) 2024-10-11

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US (2) US11274159B2 (hr)
EP (2) EP3625259B1 (hr)
JP (1) JP7171617B2 (hr)
KR (1) KR102714600B1 (hr)
CN (2) CN110799536B (hr)
AR (1) AR111630A1 (hr)
AU (1) AU2018268304B2 (hr)
BR (1) BR112019023754A2 (hr)
CA (1) CA3063622A1 (hr)
CL (1) CL2019003266A1 (hr)
DK (1) DK3625259T3 (hr)
ES (1) ES2981193T3 (hr)
FI (1) FI3625259T3 (hr)
HR (1) HRP20240924T1 (hr)
HU (1) HUE067040T2 (hr)
LT (1) LT3625259T (hr)
MX (1) MX2019013749A (hr)
MY (1) MY199247A (hr)
PL (1) PL3625259T3 (hr)
PT (1) PT3625259T (hr)
RU (1) RU2771174C2 (hr)
TW (1) TWI710574B (hr)
WO (2) WO2018210795A1 (hr)

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