HRP20200185T1 - Metode za unaprjeđenje alergen-specifične imunoterapije primjenom inhibitora il-4r - Google Patents

Metode za unaprjeđenje alergen-specifične imunoterapije primjenom inhibitora il-4r Download PDF

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HRP20200185T1
HRP20200185T1 HRP20200185TT HRP20200185T HRP20200185T1 HR P20200185 T1 HRP20200185 T1 HR P20200185T1 HR P20200185T T HRP20200185T T HR P20200185TT HR P20200185 T HRP20200185 T HR P20200185T HR P20200185 T1 HRP20200185 T1 HR P20200185T1
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pharmaceutical preparation
once
weeks
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allergen
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HRP20200185TT
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Neil Stahl
Jamie M. Orengo
Andrew J. Murphy
Namita GANDHI
Neil Graham
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Regeneron Pharmaceuticals, Inc.
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    • 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
    • C07K16/2866Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/20Interleukins [IL]
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • 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
    • 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
    • A61K2039/545Medicinal 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
    • A61K2039/57Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/577Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 tolerising response
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
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  • Engineering & Computer Science (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Gastroenterology & Hepatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Claims (12)

1. Farmaceutski pripravak koji sadrži antagonist receptora interleukina-4 (IL-4R) za primjenu u metodi za unaprjeđenje učinkovitosti i/ili neškodljivosti režima alergen-specifične imunoterapije (engl. specific immunotherapy, SIT), pri čemu se metoda sastoji od primjene terapijski učinkovite količine predmetnog pripravka kod subjekta neposredno prije ili istovremeno sa režimom SIT, naznačeno time, što alergen predstavlja alergen koji se nalazi u prehrambenom proizvodu, naznačeno time, što antagonist IL-4R predstavlja antitijelo IL-4Rα ili njegov fragment koji se vezuje za antigen, naznačeno time, što HCVR antitijela ili njegovog fragmenta koji se vezuje za antigen sadrži aminokiselinsku sekvencu SEQ ID NO: 1, a LCVR sadrži aminokiselinsku sekvencu SEQ ID NO: 2.
2. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 1, naznačen time, što režim SIT obuhvaća fazu progresivnog doziranja nakon koje slijedi faza održavanja.
3. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 2, naznačen time, što režim SIT predstavlja ubrzani režim SIT, koji se sastoji od faze progresivnog doziranja kraće od 5 dana.
4. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 2, naznačen time, što se farmaceutski pripravak primjenjuje kod subjekta jednom tjedno, jednom svaka dva tjedna, jednom svaka tri tjedna ili jednom mjesečno, prije ili tijekom faze progresivnog doziranja.
5. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 2, naznačen time, što se farmaceutski pripravak primjenjuje kod subjekta jednom tjedno, jednom svaka dva tjedna, jednom svaka tri tjedna ili jednom mjesečno, tijekom ili nakon faze održavanja.
6. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 2, naznačen time, što se farmaceutski pripravak primjenjuje kod subjekta jednom tjedno, jednom svaka dva tjedna, jednom svaka tri tjedna ili jednom mjesečno, za cijelo vrijeme trajanja režima SIT.
7. Farmaceutski pripravak za primjenu u metodi prema bilo kojem patentnom zahtjevu od 1 do 6, naznačen time, što se režim SIT sastoji od primjene alergena iz hrane dobivenog iz prehrambenog proizvoda odabranog iz skupine koja se sastoji od mliječnih proizvoda, jaja, pšenice, soje, ribe, školjkaša, kikirikija i orašastih plodova.
8. Farmaceutski pripravak za primjenu u metodi prema bilo kojem patentnom zahtjevu od 1 do 7, naznačen time, što farmaceutski pripravak sadrži od 0,05 do 600 mg antagonista IL-4R.
9. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 8, naznačen time, što farmaceutski pripravak sadrži 300 mg antagonista IL-4R.
10. Farmaceutski pripravak za primjenu u metodi prema bilo kojem patentnom zahtjevu od 1 do 9, naznačen time, što se farmaceutski pripravak primjenjuje kod subjekta u kombinaciji s drugim terapijskim sredstvom odabranim iz skupine koja se sastoji od kortikosteroida, antihistaminika, sredstava za dekongestiju i sredstava protiv IgE.
11. Farmaceutski pripravak za primjenu u metodi prema bilo kojem patentnom zahtjevu od 1 do 10, naznačen time, što se antitijelo ili njegov fragment koji se vezuje za antigen vezuje za IL-4Rα i sprječava interakciju između IL-4 i/ili IL-13 s receptorom IL-4 tipa 1 ili tipa 2.
12. Farmaceutski pripravak za primjenu u metodi prema bilo kojem od prethodnih patentnim zahtjeva, naznačen time što je antitijelo IL-4Rα dupilumab.
HRP20200185TT 2013-06-04 2020-02-05 Metode za unaprjeđenje alergen-specifične imunoterapije primjenom inhibitora il-4r HRP20200185T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361830919P 2013-06-04 2013-06-04
PCT/US2014/040695 WO2014197470A1 (en) 2013-06-04 2014-06-03 Mehods for treating allergy and enhancing allergen-specific immunotherapy by administering an il-4r inhibitor
EP14733922.0A EP3004166B1 (en) 2013-06-04 2014-06-03 Methods for enhancing allergen-specific immunotherapy by administering an il-4r inhibitor

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HRP20200185T1 true HRP20200185T1 (hr) 2020-05-01

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US (5) US10392439B2 (hr)
EP (2) EP3617233A1 (hr)
JP (5) JP6499167B2 (hr)
KR (3) KR102355114B1 (hr)
CN (3) CN105377894A (hr)
AU (3) AU2014275094C1 (hr)
CA (1) CA2914203C (hr)
CY (1) CY1124095T1 (hr)
DK (1) DK3004166T3 (hr)
ES (1) ES2767080T3 (hr)
HK (1) HK1216898A1 (hr)
HR (1) HRP20200185T1 (hr)
HU (1) HUE048655T2 (hr)
IL (2) IL242456B (hr)
LT (1) LT3004166T (hr)
MX (2) MX2015016473A (hr)
NZ (1) NZ630183A (hr)
PL (1) PL3004166T3 (hr)
PT (1) PT3004166T (hr)
RS (1) RS59883B1 (hr)
RU (1) RU2679920C2 (hr)
SG (3) SG10201913835XA (hr)
SI (1) SI3004166T1 (hr)
TW (3) TWI755763B (hr)
WO (1) WO2014197470A1 (hr)
ZA (1) ZA201508174B (hr)

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