HRP20191449T1 - Anti-b7-h1 i anti-ctla-4 protutijela za liječenje raka pluća ne-malih stanica - Google Patents

Anti-b7-h1 i anti-ctla-4 protutijela za liječenje raka pluća ne-malih stanica Download PDF

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HRP20191449T1
HRP20191449T1 HRP20191449T HRP20191449T1 HR P20191449 T1 HRP20191449 T1 HR P20191449T1 HR P20191449 T HRP20191449 T HR P20191449T HR P20191449 T1 HRP20191449 T1 HR P20191449T1
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combination
use according
antigen
binding fragment
nsclc
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Rajesh Narwal
Paul Robbins
Joyson Karakunnel
Mohammed M Dar
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Medimmune Ltd
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    • 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
    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, 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
    • 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
    • C07K16/2818Immunoglobulins [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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or 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
    • 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
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K16/2827Immunoglobulins [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 B7 molecules, e.g. CD80, CD86
    • 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
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507Comprising a combination of two or more separate antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/58Medicinal preparations containing antigens or antibodies raising an immune response against a target which is not the antigen used for immunisation
    • A61K2039/585Medicinal preparations containing antigens or antibodies raising an immune response against a target which is not the antigen used for immunisation wherein the target is cancer
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Oncology (AREA)
  • Endocrinology (AREA)
  • Biomedical Technology (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)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (17)

1. Kombinacija koja sadrži MEDI4736, ili njegov fragment koji veže antigen, i tremelimumab, ili njegov fragment koji veže antigen, naznačena time što je za uporabu u liječenju NSCLC kod ljudskog pacijenta, pri čemu se MEDI-4736 primjenjuje u dozi od 20 mg/kg svaka 4 tjedna, a tremelimumab se daje pacijentu u dozi od 1 mg/kg.
2. Kombinacija za uporabu prema patentnom zahtjevu 1, naznačena time što se odgovor tumora može otkriti do 2, 4, 6, 8, 10, 33 ili 50-tog tjedna.
3. Kombinacija za uporabu prema patentnom zahtjevu 1 ili 2 , naznačena time što primjene povećavaju preživljavanje bez progresije.
4. Kombinacija za uporabu prema patentnom zahtjevu 3, naznačena time što primjene rezultiraju povećanjem preživljenja bez progresije u usporedbi s primjenama bilo samog MEDI4736, ili njegovog fragmenta koji veže antigen, ili samog tremelimumaba, ili njegovog fragmenta koji veže antigen.
5. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-4, naznačena time što je NSCLC otporan na najmanje jedno kemoterapijsko sredstvo.
6. Kombinacija za uporabu prema patentnom zahtjevu 5, naznačena time što je kemoterapijsko sredstvo Vemurafenib, Erlotinib, Afatinib, Cetuksimab, Karboplatin, Bevacizumab, Erlotinib, Gefitinib, ili Pemetreksed.
7. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-6, naznačena time što pacijent ima status uspješnosti Eastern Cooperative Oncology Group (ECOG) od 0-1.
8. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-7, naznačena time što pacijent nije primao imunoterapiju prije davanja MEDI4736 ili njegovog fragmenta koji veže antigen i tremelimumaba ili njegovog fragmenta koji veže antigen.
9. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-8, naznačena time što se davanje MEDI4736 ili njegovog fragmenta koji veže antigen provodi putem intravenske infuzije.
10. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-9, naznačena time što se davanje tremelimumaba ili njegovog fragmenta koji veže antigen provodi putem intravenske infuzije.
11. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-10, naznačena time što primjene smanjuju veličinu tumora za najmanje oko 10%, 25% ili 50% u odnosu na baznu liniju.
12. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-11, naznačena time što human pacijent ima lokalno uznapredovali neresektabilni ili metastatski NSCLC.
13. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-12, naznačena time što je NSCLC skvamozan ili ne-skvamozan.
14. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što NSCLC obuhvaća KRAS-mutaciju ili EGFR-mutaciju.
15. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-14, naznačena time što je NSCLC PD-L1 pozitivan.
16. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-14, naznačena time što je NSCLC PD-L1 negativan.
17. Kombinacija za uporabu prema bilo kojem od patentnih zahtjeva 1-16, naznačena time što se MEDI4736 primjenjuje svakih 4 tjedna tijekom 49 tjedana.
HRP20191449 2014-05-13 2019-08-09 Anti-b7-h1 i anti-ctla-4 protutijela za liječenje raka pluća ne-malih stanica HRP20191449T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201461992658P 2014-05-13 2014-05-13
US201562105992P 2015-01-21 2015-01-21
US201562114336P 2015-02-10 2015-02-10
PCT/EP2015/060523 WO2015173267A1 (en) 2014-05-13 2015-05-12 Anti-b7-h1 and anti-ctla-4 antibodies for treating non-small cell lung cancer
EP15722195.3A EP3142751B1 (en) 2014-05-13 2015-05-12 Anti-b7-h1 and anti-ctla-4 antibodies for treating non-small cell lung cancer

Publications (1)

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HRP20191449T1 true HRP20191449T1 (hr) 2019-11-15

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HRP20191449 HRP20191449T1 (hr) 2014-05-13 2019-08-09 Anti-b7-h1 i anti-ctla-4 protutijela za liječenje raka pluća ne-malih stanica

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US (3) US10232040B2 (hr)
EP (2) EP3142751B1 (hr)
JP (4) JP6648038B2 (hr)
KR (4) KR20230165876A (hr)
CN (2) CN106456756B (hr)
AU (3) AU2015260962B2 (hr)
BR (2) BR112016026197A2 (hr)
CA (1) CA2947471A1 (hr)
CY (1) CY1122642T1 (hr)
DK (1) DK3142751T3 (hr)
ES (1) ES2749098T3 (hr)
GB (1) GB2531094A (hr)
HR (1) HRP20191449T1 (hr)
HU (1) HUE045965T2 (hr)
IL (2) IL248528B (hr)
LT (1) LT3142751T (hr)
ME (1) ME03493B (hr)
MX (1) MX2016014189A (hr)
PL (1) PL3142751T3 (hr)
PT (1) PT3142751T (hr)
RS (1) RS59134B1 (hr)
RU (1) RU2702332C2 (hr)
SG (2) SG11201609285SA (hr)
SI (1) SI3142751T1 (hr)
TW (3) TWI780994B (hr)
WO (1) WO2015173267A1 (hr)

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