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HRP20192052T1 - Protutijela anti-siglec-8 te njihovi postupci i uporabe - Google Patents

Protutijela anti-siglec-8 te njihovi postupci i uporabe Download PDF

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Publication number
HRP20192052T1
HRP20192052T1 HRP20192052TT HRP20192052T HRP20192052T1 HR P20192052 T1 HRP20192052 T1 HR P20192052T1 HR P20192052T T HRP20192052T T HR P20192052TT HR P20192052 T HRP20192052 T HR P20192052T HR P20192052 T1 HRP20192052 T1 HR P20192052T1
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Croatia
Prior art keywords
antibody
seq
amino acid
acid sequence
region
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HRP20192052TT
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English (en)
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Christopher R. Bebbington
Rustom FALAHATI
Carolina Rita Sousa Fernandes
David John Matthews
Nenad Tomasevic
Jason Williams
John Leung
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Allakos Inc.
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Publication of HRP20192052T1 publication Critical patent/HRP20192052T1/hr

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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/0005Vertebrate antigens
    • 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
    • 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
    • A61K39/39566Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against immunoglobulins, e.g. anti-idiotypic antibodies
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41Glycosylation, sialylation, or fucosylation
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    • 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
    • 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567Framework region [FR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
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    • 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
    • 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
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
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    • 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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  • Immunology (AREA)
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  • Medicinal Chemistry (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Claims (22)

1. Humanizirano protutijelo koje se veže na humani Siglec-8, naznačeno time, da protutijelo obuhvaća varijabilno područje teškog lanca i varijabilno područje lakog lanca, pri čemu (i) varijabilno područje teškog lanca sadrži aminokiselinski slijed od SEQ ID NO:6 a varijabilno područje lakog lanca sadrži sadrži aminokiselinski slijed od SEQ ID NO:16 ili SEQ ID NO:21; ili (ii) (a) varijabilno područje teškog lanca sadrži: (1) HC-FR1 koji sadrži aminokiselinski slijed od SEQ ID NO:26; (2) HVR-H1 koji sadrži aminokiselinski slijed od SEQ ID NO:61; (3) HC-FR2 koji sadrži aminokiselinski slijed od SEQ ID NO:34; (4) HVR-H2 koji sadrži aminokiselinski slijed od SEQ ID NO:62; (5) HC-FR3 koji sadrži aminokiselinski slijed od SEQ ID NO:38; (6) HVR-H3 koji sadrži aminokiselinski slijed od SEQ ID NO:63; i (7) HC-FR4 koji sadrži aminokiselinski slijed od SEQ ID NO:45; i (b) varijabilno područje lakog lanca koje sadrži: (1) LC-FR1 koji sadrži aminokiselinski slijed od SEQ ID NO:48; (2) HVR-L1 koji sadrži aminokiselinski slijed od SEQ ID NO:64; (3) LC-FR2 koji sadrži aminokiselinski slijed od SEQ ID NO:51; (4) HVR-L2 koji sadrži aminokiselinski slijed od SEQ ID NO:65; (5) LC-FR3 koji sadrži aminokiselinski slijed od SEQ ID NO:55 ili 58; (6) HVR-L3 koji sadrži aminokiselinski slijed od SEQ ID NO:66; i (7) LC-FR4 koji sadrži aminokiselinski slijed od SEQ ID NO:60.
2. Protutijelo prema patentnom zahtjevu 1(i), naznačeno time, da protutijelo obuhvaća Fc područje teškog lanca koje sadrži humano IgG Fc područje.
3. Protutijelo prema patentnom zahtjevu 2, naznačeno time, da humano IgG Fc područje je humano IgG1 Fc područje ili humano IgG4 Fc područje.
4. Protutijelo prema patentnom zahtjevu 3, naznačeno time, da humani IgG4 obuhvaća aminokiselinsku supstituciju S228P, a ostaci su numerirani u skladu s EU indeksom u Kabat-sustavu numeriranja.
5. Protutijelo prema patentnom zahtjevu 1(i), naznačeno time, da teški lanac sadrži aminokiselinski slijed od SEQ ID NO:75 ili SEQ ID NO:87, a laki lanac sadrži aminokiselinski slijed od SEQ ID NO:76.
6. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačeno time, da protutijelo obuhvaća najmanje jednu aminokiselinsku supstituciju u Fc području koja poboljšava aktivitet citotoksičnosti posredstvom stanice u ovisnosti o protutijelu (ADCC - engl. antibody-dependent cell-mediated cytotoxicity).
7. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačeno time, da je jedan ili su dva teška lanca protutjela ne-fukoziliran(a).
8. Nukleinska kiselina, naznačena time, da kodira protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 7.
9. Vektor, naznačen time, da obuhvaća nukleinsku kiselinu prema patentnom zahtjevu 8.
10. Izolirana stanica domaćina, naznačena time, da obuhvaća nukleinsku kiselinu prema patentnom zahtjevu 8.
11. Izolirana stanica domaćina prema patentnom zahtjevu 10, naznačena time, da stanica domaćina predstavlja staničnu liniju s izbacivanjem gena alfa1,6-fukoziltransferaze (Fut8) ili staničnu liniju koja prekomjerno izražava ß1,4-N-acetilglukoziminiltransferazu III (GnT-III).
12. Izolirana stanica domaćina prema patentnom zahtjevu 11, naznačena time, da stanična linija dodatno prekomjerno izražava Golgi μ-manosidazu II (ManII).
13. Postupak proizvodnje protutijela, naznačen time, da obuhvaća kultiviranje stanice domaćina u skladu s bilo kojim od patentnih zahtjeva 10 do 12, pod uvjetima koji proizvode protutijelo.
14. Protutijelo anti-Siglec-8, naznačeno time, da se proizvodi putem postupka koji obuhvaća kultiviranje stanice domaćina koja sadrži nukleinsku kiselinu prema patentnom zahtjevu 8, ili kultiviranje stanice domaćina u skladu s bilo kojim od patentnih zahtjeva 10 do 12, pod uvjetima koji proizvode protutijelo, pri čemu stanica domaćina je stanica sisavca.
15. Pripravak, naznačen time, da obuhvaća protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 7 i 14, pri čemu protutijelo obuhvaća Fc područje i na to Fc područje povezane ugljikohidratne lance koji su povezani s N-glikozidom, gdje manje od 50% ugljikohidratnih lanaca koji su povezani s N-glikozidom, sadrži ostatak fukoze.
16. Pripravak prema patentnom zahtjevu 15, naznačen time, da u biti niti jedan od ugljikohidratnih lanaca koji su povezani s N-glikozidom, ne sadrži ostatak fukoze.
17. Farmaceutski pripravak, naznačen time, da obuhvaća protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 7 i 14, i farmaceutski prihvatljiv nosač.
18. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 7 i 14 ili pripravak u skladu s bilo kojim od patentnih zahtjeva 15 do 17, naznačeni time, da se upotrebljavaju u postupku liječenja.
19. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 7 i 14 ili pripravak u skladu s bilo kojim od patentnih zahtjeva 15 do 17, naznačeni time, da se upotrebljavaju u postupku liječenja bolesti koja je odabrana iz skupine koja se sastoji od sljedećih: astma, alergijski rinitis, nosni polipi, atopijski dermatitis, kronična urtikarija, mastocitoza, eozinofilna leukemija, hipereozinofilni sindrom, astma s pomanjkanjem granulocita, akutna ili kronična hipersenzibilnost dišnih puteva, eozinofilni ezofagitis, Churg-Straussov sindrom, fizikalna urtikarija, hladna urtikarija, tlačna utrikarija, bulozni pemfigoid, alergija na hranu, i alergijska bronhopulmonarna aspergiloza (ABPA).
20. Protutijelo za uporabu ili pripravak za uporabu u skladu s patentnim zahtjevom 18, naznačeni time, da protutijelo ili pripravak inhibiraju jedan ili više simptoma alergijske reakcije, pri čemu je alergijska reakcija opcionalno jedna hipersenzitivna reakcija Tipa I.
21. Protutijelo za uporabu ili pripravak za uporabu u skladu s patentnim zahtjevom 18, naznačeni time, da postupak liječenja uključuje iscrpljivanje mastocita koji eksprimiraju Siglec-8, pomoću ADCC-akiviteta.
22. Protutijelo za uporabu ili pripravak za uporabu u skladu s patentnim zahtjevom 18, naznačeni time, da postupak liječenja uključuje iscrpljivanje eozinofila koji eksprimiraju Siglec-8, pomoću ADCC-akiviteta.
HRP20192052TT 2013-12-09 2019-11-13 Protutijela anti-siglec-8 te njihovi postupci i uporabe HRP20192052T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361913891P 2013-12-09 2013-12-09
EP14869424.3A EP3079719B8 (en) 2013-12-09 2014-12-09 Anti-siglec-8 antibodies and methods of use thereof
PCT/US2014/069409 WO2015089117A1 (en) 2013-12-09 2014-12-09 Anti-siglec-8 antibodies and methods of use thereof

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HRP20192052T1 true HRP20192052T1 (hr) 2020-02-07

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US (4) US9546215B2 (hr)
EP (2) EP3079719B8 (hr)
JP (4) JP6549143B2 (hr)
KR (3) KR102311761B1 (hr)
CN (3) CN105916519B (hr)
AU (2) AU2014363944B2 (hr)
BR (1) BR112016013109B1 (hr)
CA (1) CA2930886C (hr)
CY (1) CY1122329T1 (hr)
DK (1) DK3079719T3 (hr)
ES (1) ES2758508T3 (hr)
HR (1) HRP20192052T1 (hr)
HU (1) HUE047283T2 (hr)
IL (3) IL298470A (hr)
LT (1) LT3079719T (hr)
NZ (1) NZ720769A (hr)
PL (1) PL3079719T3 (hr)
PT (1) PT3079719T (hr)
RS (1) RS59567B1 (hr)
SG (2) SG11201604632PA (hr)
SI (1) SI3079719T1 (hr)
WO (1) WO2015089117A1 (hr)
ZA (1) ZA201603435B (hr)

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KR20210005245A (ko) * 2018-05-04 2021-01-13 알라코스 인크. 만성 두드러기를 치료하기 위한 방법 및 조성물
SG11202108833QA (en) * 2019-02-15 2021-09-29 Allakos Inc Methods and compositions for treating mast cell gastritis, mast cell esophagitis, mast cell enteritis, mast cell duodenitis, and/or mast cell gastroenteritis
JP2022542472A (ja) * 2019-08-02 2022-10-03 アラコス インコーポレイテッド 抗siglec-8抗体および副腎皮質ステロイド薬を投与する方法
JP2022553378A (ja) * 2019-10-24 2022-12-22 アラコス インコーポレイテッド 過敏性腸症候群および機能性ディスペプシアを処置するための方法および組成物
CA3158364A1 (en) * 2019-11-19 2021-05-27 The Trustees Of The University Of Pennsylvania Anti-alpha-synuclein monoclonal antibodies, and methods using same
US20230210989A1 (en) * 2020-06-03 2023-07-06 Kar Muthumani Monoclonal Antibody Against Human Siglec-9 and Use For Immunotherapy
WO2022061032A1 (en) * 2020-09-17 2022-03-24 Allakos Inc. Methods and compositions for treating viral infection
JPWO2022215566A1 (hr) * 2021-04-05 2022-10-13
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