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HRP20211703T1 - Protutijela protiv pd-1 i njihova upotreba - Google Patents

Protutijela protiv pd-1 i njihova upotreba Download PDF

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Publication number
HRP20211703T1
HRP20211703T1 HRP20211703TT HRP20211703T HRP20211703T1 HR P20211703 T1 HRP20211703 T1 HR P20211703T1 HR P20211703T T HRP20211703T T HR P20211703TT HR P20211703 T HRP20211703 T HR P20211703T HR P20211703 T1 HRP20211703 T1 HR P20211703T1
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Croatia
Prior art keywords
antibody
cancer
seq
amino acid
acid sequence
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HRP20211703TT
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English (en)
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George Robert MABRY III
Stephen Sazinsky
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Jounce Therapeutics, Inc.
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Application filed by Jounce Therapeutics, Inc. filed Critical Jounce Therapeutics, Inc.
Publication of HRP20211703T1 publication Critical patent/HRP20211703T1/hr

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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
    • C07K16/2803—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
    • 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
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • C07K16/2803—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
    • 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
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
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    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
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    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/64—General methods for preparing the vector, for introducing it into the cell or for selecting the vector-containing host
    • C—CHEMISTRY; METALLURGY
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    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/66—General methods for inserting a gene into a vector to form a recombinant vector using cleavage and ligation; Use of non-functional linkers or adaptors, e.g. linkers containing the sequence for a restriction endonuclease
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    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/10—Cells modified by introduction of foreign genetic material
    • 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
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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
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    • C07K2317/00—Immunoglobulins specific features
    • 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
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • 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
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • 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
    • C07K2317/90—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

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  • Proteomics, Peptides & Aminoacids (AREA)
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  • Epidemiology (AREA)
  • Mycology (AREA)
  • Oncology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
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Claims (19)

1. Izolirano monoklonsko protutijelo koje se veže na ljudski protein Programmed Death 1 (PD-1) [programirana smrt], naznačeno time što protutijelo sadrži (a) HCDR1, koji sadrži aminokiselinski slijed SEQ ID NO: 21; (b) HCDR2, koji sadrži aminokiselinski slijed SEQ ID NO: 22; (c) HCDR3, koji sadrži aminokiselinski slijed SEQ ID NO: 23; (d) LCDR1, koji sadrži aminokiselinski slijed SEQ ID NO: 25; (e) LCDR2, koji sadrži aminokiselinski slijed SEQ ID NO: 26; i (f) LCDR3, koji sadrži aminokiselinski slijed SEQ ID NO: 27.
2. Izolirano monoklonsko protutijelo u skladu s patentnim zahtjevom 1, naznačeno time što sadrži varijabilno područje teškog lanca (VH) i varijabilno područje lakog lanca (VL), gdje je VH najmanje 95% istovjetan aminokiselinskom slijedu SEQ ID NO: 20, a VL je najmanje 95% istovjetan aminokiselinskom slijedu SEQ ID NO: 24.
3. Izolirano monoklonsko protutijelo u skladu s patentnim zahtjevom 1, naznačeno time što sadrži varijabilno područje teškog lanca (VH) i varijabilno područje lakog lanca (VL), gdje VH sadrži aminokiselinski slijed SEQ ID NO: 20, a VL sadrži aminokiselinski slijed SEQ ID NO: 24.
4. Izolirano monoklonsko protutijelo u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time što se protutijelo veže na ljudski PD-1 s afinitetom (KD) manjim od 5 nM, što je određeno interferometrijom u biosloju.
5. Izolirano monoklonsko protutijelo u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time što se protutijelo veže na mišji PD-1 s afinitetom (KD) manjim od 10 nM, što je određeno interferometrijom u biosloju.
6. Izolirano monoklonsko protutijelo u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time što je protutijelo ljudsko protutijelo.
7. Izolirano monoklonsko protutijelo u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time što je protutijelo fragment protutijela kojeg se bira između fragmenta Fab, Fab’, Fv, scFv ili (Fab’)2.
8. Izolirano monoklonsko protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačeno time što je protutijelo protutijelo pune duljine.
9. Izolirano monoklonsko protutijelo u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time što protutijelo inhibira vezanje PD-1 na PD-L1 i/ili inhibira vezanje PD-1 na PD-L2.
10. Izolirana nukleinska kiselina, naznačena time što kodira protutijelo u skladu s bilo kojim od prethodnih patentnih zahtjeva.
11. Stanica domaćin, naznačena time što proizvodi protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9.
12. Postupak proizvodnje protutijela protiv PD-1, naznačen time što se sastoji u uzgoju stanice domaćina u skladu s patentnim zahtjevom 11 u uvjetima pogodnim za eksprimiranje protutijela, uz izborno prikupljanje protutijela.
13. Farmaceutski pripravak, naznačen time što sadrži protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9 i farmaceutski prihvatljivi nosač.
14. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9 ili farmaceutski pripravak u skladu s patentnim zahtjevom 13, naznačeni time što su namijenjeni upotrebi u liječenju raka.
15. Protutijelo ili farmaceutski pripravak namijenjeni upotrebi u skladu s patentnim zahtjevom 14, naznačeni time što se rak bira između melanoma, raka velikih stanica pluća (NSCLC), karcinoma bubrežnih stanica (RCC), raka želuca, raka mokraćnog mjehura, difuznog limfoma velikih B-stanica (DLBCL), Hodgkinovog limfoma, raka jajnika, raka pločastih stanica glave i vrata (HNSCC), mezotelioma, te trostruko negativnog raka dojke (TNBC).
16. Protutijelo ili farmaceutski pripravak namijenjeni upotrebi u skladu s patentnim zahtjevom 15, naznačeni time što se rak bira između melanoma, raka želuca, raka pločastih stanica glave i vrata (HNSCC), raka velikih stanica pluća (NSCLC), te trostruko negativnog raka dojke (TNBC).
17. Protutijelo ili farmaceutski pripravak namijenjeni upotrebi u skladu s bilo kojim od patentnih zahtjeva 14 do 16, naznačeni time što se liječenje sastoji u primjeni najmanje jednog dodatnog terapijskog sredstva.
18. Protutijelo ili farmaceutski pripravak namijenjeni upotrebi u skladu s patentnim zahtjevom 17, naznačeni time što se dodatno terapijsko sredstvo bira između protutijela protiv ICOS i protutijela protiv CTLA4.
19. Protutijelo ili farmaceutski pripravak namijenjeni upotrebi u skladu s bilo kojim od patentnih zahtjeva 14 do 18, naznačeni time što je za uzorak raka određeno da eksprimira PD-1, gdje uzorak može pokazivati 1+, 2+, ili 3+ imunohistokemijsko bojanje PD-1 (IHC); ili što je za uzorak određeno da ima povišenu razinu PD-L1, gdje se razine PD-L1 može određivati uz pomoć IHC.
HRP20211703TT 2016-11-02 2017-11-01 Protutijela protiv pd-1 i njihova upotreba HRP20211703T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662416602P 2016-11-02 2016-11-02
PCT/US2017/059481 WO2018085358A1 (en) 2016-11-02 2017-11-01 Antibodies to pd-1 and uses thereof
EP17808224.4A EP3535298B1 (en) 2016-11-02 2017-11-01 Antibodies to pd-1 and uses thereof

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HRP20211703T1 true HRP20211703T1 (hr) 2022-02-04

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EP (2) EP3988569A1 (hr)
JP (2) JP7086066B2 (hr)
KR (1) KR20190088480A (hr)
CN (1) CN110392694B (hr)
AR (1) AR110017A1 (hr)
AU (1) AU2017355401A1 (hr)
BR (1) BR112019008494A2 (hr)
CA (1) CA3039992A1 (hr)
CY (1) CY1124730T1 (hr)
DK (1) DK3535298T3 (hr)
ES (1) ES2898025T3 (hr)
HR (1) HRP20211703T1 (hr)
HU (1) HUE057559T2 (hr)
IL (1) IL266259A (hr)
LT (1) LT3535298T (hr)
MA (1) MA46708B1 (hr)
MD (1) MD3535298T2 (hr)
MX (1) MX2019004834A (hr)
MY (1) MY195110A (hr)
PL (1) PL3535298T3 (hr)
PT (1) PT3535298T (hr)
RS (1) RS62589B1 (hr)
RU (1) RU2761640C2 (hr)
SG (1) SG11201903857UA (hr)
SI (1) SI3535298T1 (hr)
TW (2) TWI781120B (hr)
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ZA (1) ZA201902455B (hr)

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