HRP20220436T1 - Protutijela koja se specifično vežu na pd-1 i njihove uporabe - Google Patents

Protutijela koja se specifično vežu na pd-1 i njihove uporabe Download PDF

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HRP20220436T1
HRP20220436T1 HRP20220436TT HRP20220436T HRP20220436T1 HR P20220436 T1 HRP20220436 T1 HR P20220436T1 HR P20220436T T HRP20220436T T HR P20220436TT HR P20220436 T HRP20220436 T HR P20220436T HR P20220436 T1 HRP20220436 T1 HR P20220436T1
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seq
antibody
cancer
antigen
isotype
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HRP20220436TT
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Raluca VERONA
Gordon Powers
Nina Chi Sabins
Nikki A. Deangelis
Sandra Santulli-Marotto
Karla R. Wiehagen
Sheng-Jiun Wu
Catherine Ferrante
Enrique-Zudaire UBANI
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Janssen Biotech, Inc.
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Publication of HRP20220436T1 publication Critical patent/HRP20220436T1/hr

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    • 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
    • C07K16/2803—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 immunoglobulin superfamily
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    • 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
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
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    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1036—Retroviridae, e.g. leukemia viruses
    • C07K16/1045—Lentiviridae, e.g. HIV, FIV, SIV
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    • C07K16/2803—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 immunoglobulin superfamily
    • C07K16/2818—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 immunoglobulin superfamily against CD28 or CD152
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    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • 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
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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    • 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
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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    • 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
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    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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Claims (15)

1. Izolirano antagonističko protutijelo koje se specifično veže na PD-1 ili njegov dio koji veže antigen, naznačeno time, da sadrži varijabilnu regiju teškog lanca (VH) od SEQ ID NO: 48 i varijabilnu regiju lakog lanca od SEQ ID NO: 56.
2. Protutijelo ili njegov dio koji veže antigen prema patentnom zahtjevu 1, naznačeno time, da sadrži teški lanac (HC) od SEQ ID NO: 72 i laki lanac (LC) od SEQ ID NO: 73.
3. Protutijelo ili njegov dio koji veže antigen prema patentnom zahtjevu 1, naznačeno time, da protutijelo posjeduje jedno, dva ili tri od sljedećih svojstava: a) pojačava aktivaciju antigenski specifičnih T stanica CD4+ ili CD8+ na način koji je ovisan o doziranju, pri čemu se aktivacija mjeri uporabom testa sjećanja antigena na infekciju citomegalovirusa (CMV test) kako je opisano u Primjeru 1; b) veže ljudski PD-1 s KD manjim od 1 nM, pri čemu se KD mjeri uporabom sustava ProteOn XPR36 na +25°C; c) veže PD-1 od SEQ ID NO: 3 Javanskog majmuna s KD manjim od 1 nM, pri čemu se KD mjeri uporabom sustava ProteOn XPR36 na +25°C.
4. Protutijelo ili njegov dio koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 3, naznačeno time, da protutijelo je ljudsko.
5. Protutijelo ili njegov dio koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 4, naznačeno time, da protutijelo je: a) izotipa IgG4; b) izotipa IgG1; c) izotipa IgG2; d) izotipa IgG3; e) izotipa IgG4 koji uključuje supstituciju S228P; f) izotipa IgG1 koji uključuje supstitucije L234A, L235A, G237A, P238S, H268A, A330S i P331S; g) izotipa IgG2 koji uključuje supstitucije V234A, G237A, P238S, H268A, V309L, A330S i P331S; h) izotipa IgG4 koji uključuje supstitucije F234A, L235A, G237A, P238S i Q268A; i) izotipa IgG1 koji uključuje supstitucije L234A, L235A ili L234A i L235A; j) izotipa IgG4 koji uključuje supstitucije F234A, L235A ili F234A i L235A; k) izotipa IgG2 koji uključuje supstituciju V234A; ili l) izotipa IgG4 koji uključuje supstitucije S228P, F234A i L235A, pri čemu je numeriranje ostatka u skladu s EU indeksom.
6. Protutijelo ili njegov dio koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 5, naznačeno time, da protutijelo je bispecifično protutijelo koje se opcionalno veže na PD-L1 (SEQ ID NO: 5), PD-L2 (SEQ ID NO: 8), LAG-3 (SEQ ID NO: 293), TIM-3 (SEQ ID NO: 138), CEACAM-1 (SEQ ID NO: 296), CEACAM-5 (SEQ ID NO: 307), OX-40 (SEQ ID NO: 279), GITR (SEQ ID NO: 271), CD27 (SEQ ID NO: 280), VISTA (SEQ ID NO: 286), CD137 (SEQ ID NO: 281), TIGIT (SEQ ID NO: 301), ili CTLA-4 (SEQ ID NO: 292).
7. Farmaceutski pripravak, naznačen time, da sadrži protutijelo ili njegov dio koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 6 i farmaceutski prihvatljiv nosač.
8. Polinukleotid, naznačen time, da: a) kodira VH od SEQ ID NO: 48 i VL od SEQ ID NO: 56; b) kodira HC od SEQ ID NO: 72 i LC od SEQ ID NO: 73; ili c) sadrži polinukleotidne sljedove od SEQ ID NO: 196 i 197.
9. Vektor, naznačen time, da sadrži polinukleotid prema patentnom zahtjevu 8.
10. Stanica domaćina, naznačena time, da sadrži: a) vektor prema patentnom zahtjevu 9; ili b) polinukleotid koji kodira VH od SEQ ID NO: 48 ili HC od SEQ ID NO: 72; ili sadrži polinukleotidni slijed od SEQ ID NO: 196; i c) polinukleotid koji kodira VL od SEQ ID NO: 56 ili LC od SEQ ID NO: 73; ili sadrži polinukleotidni slijed od SEQ ID NO: 197.
11. Postupak za proizvodnju antagonističkog protutijela koje se specifično veže na PD-1 ili njegovog dijela koji veže antigen, naznačen time, da obuhvaća kultiviranje stanice domaćina prema patentnom zahtjevu 10, u uvjetima u kojima se eksprimira protutijelo ili njegov dio koji veže antigen, i dobivanje protutijela ili njegovog dijela koji veže antigen, koji se proizvode putem stanice domaćina.
12. Izolirano protutijelo ili njegov dio koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 6, ili farmaceutski pripravak prema patentnom zahtjevu 7, naznačen/o time, da je za uporabu u postupku liječenja raka kod pojedinca.
13. Izolirano protutijelo ili njegov dio koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 6, ili farmaceutski pripravak prema patentnom zahtjevu 7, za uporabu prema patentnom zahtjevu 12, naznačen/o time, da rak je: (a) čvrsti tumor, primjerice melanom, rak pluća, rak pločastih nemalih stanica pluća (NSCLC), rak nepločastih NSCLC, kolorektalni rak, rak prostate, rak prostate otporan na kastraciju, rak želuca, rak jajnika, gastrički rak, rak jetre, rak gušterače, rak tiroidne žlijezde, karcinom pločastih stanica glave i vrata, karcinomi jednjaka i gastrointestinalnog trakta, rak dojke, rak falopijeve cijevi, rak mozga, rak uretre, rak genitourinarnog trakta, endometrioza, rak grlića maternice, ili metastatske lezije raka; ili (b) hematološke malignosti, primjerice limfom, mijelom ili leukemija.
14. Protutijelo ili njegov dio koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 6, ili farmaceutski pripravak prema patentnom zahtjevu 7, naznačen/o time, da je za uporabu u postupku poboljšavanja imunosnog odgovora kod pojedinca kojemu je to potrebno, u vremenskom periodu koji je dostatan da poboljša imunosni odgovor, opcionalno pri čemu pojedinac ima rak ili virusnu infekciju.
15. Protutijelo ili njegov dio koji veže antigen prema bilo kojem od patentnih zahtjeva 1 do 6, ili farmaceutski pripravak prema patentnom zahtjevu 7, za uporabu prema bilo kojem od patentnih zahtjeva 12 do 14, naznačen/o time, da se protutijelo, njegov dio koji veže antigen ili farmaceutski pripravak daje u kombinaciji s drugačijim terapijskim sredstvom, pri čemu se opcionalno: (A) protutijelo ili njegov dio koji veže antigen i drugačije terapijsko sredstvo daju istovremeno, uzastopno ili odvojeno, i/ili (B) drugačije terapijsko sredstvo je: a) lijek standardne medicinske njege za liječenje čvrstog tumora ili hematološke malignosti, pri čemu je lijek standardne medicinske njege anastrozol, bikalutamid, bleomicin sulfat, busulfan, busulfanska injekcija, kapecitabin, N4-pentoksikarbonil-5-deoksi-5-fluorocitidin, karboplatin, karmustin, klorambucil, cisplatin, kladribin, ciklofosfamid, citarabin, citozin arabinozid, citarabin liposomska injekcija, dakarbazin, daktinomicin, daunorubicin hidroklorid, daunorubicin citrat liposomska injekcija, deksametazon, docetaksel, doksorubicin hidroklorid, etopozid, fludarabin fosftat, 5-fluorouracil, flutamid, tezacitibin, gemcitabin (difluorodeoksicitidin), hidroksiurea, idarubicin, ifosfamid, irinotekan, L-asparaginaza, leukovorin kalcij, melfalan, 6-merkaptopurin, metotreksat, mitoksantron, paklitaksel, feniks, pentostatin, polifeprosan 20 s karmustinskim implantom, tamoksifen citrat, tenipozid, 6-tiogvanin, tiotepa, tirapazamin, topotekan hidroklorid za injekciju, vinblastin, vinkristin, vinorelbin, ibrutinib, idelalisib, ili brentuksimab vedotin; b) agonist od CD86 (SEQ ID NO: 264), CD80 (SEQ ID NO: 265), CD28 (SEQ ID NO: 266), ICOS (SEQ ID NO: 267), ICOS ligand (SEQ ID NO: 268), TMIGD2 (SEQ ID NO: 269), CD40 (SEQ ID NO: 270), GITR (SEQ ID NO: 271), 4-1BB ligand (SEQ ID NO: 271), OX40 ligand (SEQ ID NO: 272), CD70 (SEQ ID NO: 274), CD40L (SEQ ID NO: 275), TNFRSF25 (SEQ ID NO: 264), LIGHT (SEQ ID NO: 277), GITR ligand (SEQ ID NO: 278), OX-40 (SEQ ID NO: 279), CD27 (SEQ ID NO: 280), CD137 (SEQ ID NO: 281), NKG2D (SEQ ID NO: 282), CD48 (SEQ ID NO: 283), CD226 (SEQ ID NO: 284), ili MICA (SEQ ID NO: 285); c) inhibitor za PD-1 (SEQ ID NO: 1), PD-L1 (SEQ ID NO: 5), PD-L2 (SEQ ID NO: 8), VISTA (SEQ ID NO: 286), BTNL2 (SEQ ID NO: 287), B7-H3 (SEQ ID NO: 288), BT-H4 (SEQ ID NO: 289), HVEM (SEQ ID NO: 290), HHLA2 (SEQ ID NO: 291), CTLA-4 (SEQ ID NO: 292), LAG-3 (SEQ ID NO: 293), TIM-3 (SEQ ID NO: 138), BTLA (SEQ ID NO: 294), CD160 (SEQ ID NO: 295), CEACAM-1 (SEQ ID NO: 296), LAIR1 (SEQ ID NO: 297), TGFβ (SEQ ID NO: 298), IL-10 (SEQ ID NO: 299), CD96 (SEQ ID NO: 300), TIGIT (SEQ ID NO: 301), NKG2A (SEQ ID NO: 302), CD112 (SEQ ID NO: 303), CD47 (SEQ ID NO: 304), SIRPA (SEQ ID NO: 305), ili CD244 (SEQ ID NO: 306); d) antagonističko protutijelo koje se specifično veže na TIM-3; e) antagonističko protutijelo koje se specifično veže na TIM-3 koji sadrži VH odnosno VL od: i) SEQ ID NO: 145 odnosno 155; ii) SEQ ID NO: 146 odnosno 156; iii) SEQ ID NO: 148 odnosno 157; iv) SEQ ID NO: 147 odnosno 155; v) SEQ ID NO: 149 odnosno 158; vi) SEQ ID NO: 150 odnosno 159; vii) SEQ ID NO: 151 odnosno 160; viii) SEQ ID NO: 152 odnosno 161; ix) SEQ ID NO: 153 odnosno 162; x) SEQ ID NO: 154 odnosno 163; ili xi) SEQ ID NO: 172 odnosno 173; f) inhibitor receptora faktora rasta fibroblasta (FGFR); g) cjepivo; h) agonističko protutijelo koje se specifično veže na GITR; i) agonističko protutijelo koje se specifično veže na OX40; j) agonističko protutijelo koje se specifično veže na OX40, koji sadrži VH odnosno VL od SEQ ID NO: 309 odnosno SEQ ID NO: 310; k) agonističko protutijelo koje se specifično veže na OX40, koji sadrži VH odnosno VL od SEQ ID NO: 311 odnosno SEQ ID NO: 312; l) agonističko protutijelo koje se specifično veže na CD137; m) radijacijska terapija; ili n) kirurški zahvat.
HRP20220436TT 2015-11-03 2016-11-01 Protutijela koja se specifično vežu na pd-1 i njihove uporabe HRP20220436T1 (hr)

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