SI2686347T1 - Protitelesa proti CD70 - Google Patents

Protitelesa proti CD70 Download PDF

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SI2686347T1
SI2686347T1 SI201231335T SI201231335T SI2686347T1 SI 2686347 T1 SI2686347 T1 SI 2686347T1 SI 201231335 T SI201231335 T SI 201231335T SI 201231335 T SI201231335 T SI 201231335T SI 2686347 T1 SI2686347 T1 SI 2686347T1
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antibody
binding fragment
seq
variable
heavy chain
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SI201231335T
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Karen Silence
Peter Ulrichts
Haard Johannes Joseph Wilhelmus De
Torsten Dreier
Michael John Scott Saunders
Harald Wajant
Sofie Maria Elvire Gabriels
Mahan Moshir
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Argenx Bvba
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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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • 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
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • C07K2317/22—Immunoglobulins specific features characterized by taxonomic origin from camelids, e.g. camel, llama or dromedary
    • 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
    • C07K2317/40—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
    • C07K2317/50—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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/77—Internalization into the cell
    • 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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Claims (13)

  1. Protitelesa proti CD70 Patentni zahtevki
    1. Protitelo ali njegov antigen vezavni fragment, ki se veže na humani CD70, kjer protitelo ali antigen vezavni fragment obsega vsaj eno težkoverižno variabilno domeno (VH), ki obsega variabilen težkoverižen CDR3, variabilen težkoverižen CDR2 in variabilen težkoverižen CDR1, in vsaj eno lahkoverižno variabilno domeno (VL), ki obsega variabilen lahkoverižen CDR3, variabilen lahkoverižen CDR2 in variabilen lahkoverižen CDR1, kjer variabilni težkoverižni CDR3 obsega ali sestoji iz SEQ ID NO: 50 (DAGYSNHVPIFDS); variabilni težkoverižni CDR2 obsega ali sestoji iz SEQ ID NO: 27 (DINNEGGTTYYADSVKG); variabilni težkoverižni CDR1 obsega ali sestoji iz SEQ ID NO: 11 (VYYMN); variabilni lahkoverižni CDR3 obsega ali sestoji iz SEQ ID NO: 160 (ALFISNPSVE); variabilni lahkoverižni CDR2 obsega ali sestoji iz SEQ ID NO: 119 (NTNTRHS); in variabilni lahkoverižni CDR1 obsega ali sestoji iz SEQ ID NO: 250 (GLKSGSVTSDNFPT).
  2. 2. Izolirano protitelo ali antigen vezavni fragment po zahtevku 1, ki obsega težkoverižno variabilno domeno (VH), ki obsega ali sestoji iz aminokislinske sekvence, prikazane kot SEQ ID NO: 223, ali aminokislinske sekvence, kije vsaj 90-, 95-, 97-, 98- ali 99-odstotno enaka le-tej, in lahkoverižno variabilno domeno (VL), ki obsega ali sestoji iz aminokislinske sekvence, prikazane kot SEQ ID NO: 241, ali aminokislinske sekvence, kije vsaj 90-, 95-, 97-, 98- ali 99-odstotno enaka le-tej.
  3. 3. Izolirano protitelo ali antigen vezavni fragment po zahtevku 2, ki obsega težkoverižno variabilno domeno (VH), ki obsega aminokislinsko sekvenco, prikazano kot SEQ ID NO: 223, ali sestoji iz nje, in lahkoverižno variabilno domeno (VL), ki obsega aminokislinsko sekvenco, prikazano kot SEQ ID NO: 241, ali sestoji iz nje.
  4. 4. Protitelo po katerem koli od prejšnjih zahtevkov, ki je himemo protitelo lama-human, kjer sta domeni VH in VL izvedeni iz lame in je ena ali več konstantih domen, izvedenih iz humanega imunoglobulina, in ki po izbiri obsega zgibno regijo, domeno CH2 in domeno CH3 humanega IgG, prednostno humanega IgGl.
  5. 5. Protitelo ali antigen vezavni fragment po katerem koli od prejšnjih zahtevkov, ki izkazuje eno ali več efektorskih funkcij, izbranih izmed protitelesno odvisne celično posredovane citotoksičnosti (ADCC), kjer protitelo ali antigen vezavni fragment po izbiri izkazuje povečano funkcijo ADCC v primerjavi z ekvivalentnim protitelesom, ki obsega naravno humano Fc-domeno, komplementno odvisne citotoksičnosti (CDC) in protitelesno odvisne celično posredovane fagocitoze (ADCP) proti celicam, ki eksprimirajo humani CD70 na celični površini, kot so CD70 eksprimirajoče rakave celice.
  6. 6. Protitelo po katerem koli od prejšnjih zahtevkov, ki je nefukoziliran IgG, prednostno nefukoziliran humani IgGl.
  7. 7. Izoliran polinukleotid, ki kodira protitelo ali antigen vezavni fragment po katerem koli od prejšnjih zahtevkov.
  8. 8. Ekspresijski vektor, ki obsega polinukleotid po zahtevku 7, funkcionalno vezan na regulatome sekvence, ki dopuščajo ekspresijo antigen vezavnega polipeptida v gostiteljski celici ali ekpresijskem sistemu brez celice.
  9. 9. Gostiteljska celica ali ekpresijski sistem brez celice, ki vsebuje ekspresijski vektor po zahtevku 8.
  10. 10. Postopek za izdelavo rekombinantnega protitelesa ali njegovega antigen vezavnega fragmenta, ki obsega kultiviranje gostiteljske celice ali ekpresijskega sistema brez celice po zahtevku 9 v razmerah, ki dopuščajo ekspresijo protitelesa ali antigen vezavnega fragmenta, in rekuperiranje eksprimiranega protitelesa ali antigen vezavnega fragmenta.
  11. 11. Farmacevtski sestavek, ki obsega protitelo ali antigen vezavni fragment po katerem koli od zahtevkov 1-6 in vsaj en farmacevtsko sprejemljiv nosilec ali ekscipient.
  12. 12. Protitelo ali antigen vezavni fragment po katerem koli od zahtevkov 1-6 za uporabo pri: (a) inhibiranju rasti CD70 eksprimirajočih tumorskih celic pri humanem pacientu; ali (b) zdravljenju ali preprečevanju raka pri humanem pacientu, kjer je rak po izbiri tisti, ki izkazuje ekspresijo CD70 z majhnim številom kopij.
  13. 13. Protitelo ali antigen vezavni fragment po katerem koli od zahtevkov 1-6 za uporabo pri zdravljenju ali preprečevanju raka pri humanem pacientu, kjer je rak izbran iz skupine, ki jo sestavljajo: velikocelični limfom B, kronična limfocitna levkemija, Burkittov limfom, Hodgkinov limfom, Nehodgkinov limfom, plaščnocelični limfom, pankreasni karcinom, kutani T-celični limfom, želodčni rak, pljučni rak, melanom, glioblastom in ovarijski rak.
SI201231335T 2011-03-16 2012-03-16 Protitelesa proti CD70 SI2686347T1 (sl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201161453390P 2011-03-16 2011-03-16
US201161503871P 2011-07-01 2011-07-01
EP12710486.7A EP2686347B1 (en) 2011-03-16 2012-03-16 Antibodies to cd70
PCT/EP2012/054733 WO2012123586A1 (en) 2011-03-16 2012-03-16 Antibodies to cd70

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US (6) US9765148B2 (sl)
EP (1) EP2686347B1 (sl)
JP (2) JP5982409B2 (sl)
CN (1) CN103596979B (sl)
AU (1) AU2012228194B2 (sl)
BR (1) BR112013021562B1 (sl)
CA (1) CA2828753C (sl)
CY (1) CY1120471T1 (sl)
DK (1) DK2686347T3 (sl)
ES (1) ES2670874T3 (sl)
HU (1) HUE039849T2 (sl)
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PL (1) PL2686347T3 (sl)
PT (1) PT2686347T (sl)
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SI (1) SI2686347T1 (sl)
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