DK2842568T3 - Farmaceutisk sammensætning til behandling og/eller forebyggelse af type i-diabetes og anvendelse deraf - Google Patents

Farmaceutisk sammensætning til behandling og/eller forebyggelse af type i-diabetes og anvendelse deraf Download PDF

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DK2842568T3
DK2842568T3 DK13785267.9T DK13785267T DK2842568T3 DK 2842568 T3 DK2842568 T3 DK 2842568T3 DK 13785267 T DK13785267 T DK 13785267T DK 2842568 T3 DK2842568 T3 DK 2842568T3
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insulin
sequence
dex
cells
group
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DK13785267.9T
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Bin Wang
Guoxing Zheng
Shuang Geng
Yizhong Wang
Qingling Yu
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Beijing Advaccine Biotechnology Co 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
    • A61K39/0005Vertebrate antigens
    • A61K39/0008Antigens related to auto-immune diseases; Preparations to induce self-tolerance
    • 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
    • A61K39/39541Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13Cyclosporins
    • 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
    • A61K38/22Hormones
    • 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
    • A61K38/22Hormones
    • A61K38/28Insulins
    • 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
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/51Lyases (4)
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
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    • 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
    • C07K16/2815Immunoglobulins [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 CD8
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    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y401/00Carbon-carbon lyases (4.1)
    • C12Y401/01Carboxy-lyases (4.1.1)
    • C12Y401/01015Glutamate decarboxylase (4.1.1.15)
    • 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
    • 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
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
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  • Microbiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Engineering & Computer Science (AREA)
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  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Obesity (AREA)
  • Transplantation (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Rheumatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Claims (8)

1. Sammensætning egnet til behandling og/eller forebyggelse af type 1-diabetes (TID), der omfatter sammensætning 1) eller 2) som den aktive ingrediens: 1) Blanding af proteinantigen og immunundertrykkende middel(er), hvor vægtforholdet mellem proteinantigenet og immunundertrykkende middel(er) er 1:1 til 10:1, 2) Blanding af epitoppeptider af proteinantigenet og immunundertrykkende middel(er), hvor vægtforholdet mellem epitoppeptiderne og immunundertrykkende middel(er) er 1:1, hvor proteinantigenet er insulin eller et fragment deraf, og hvor det immunundertrykkende middel er valgt fra gruppen bestående af dexamethason (Dex), tacrolimus (FK506), cyclosporin (CsA), prednison (Pred), methylprednisolon (MP) og kombinationer deraf.
2. Sammensætning ifølge krav 1, hvor det immunundertrykkende middel er dexamethason (Dex).
3. Sammensætning ifølge krav 1, hvor sekvensen af insulin og fragmenter deraf er menneske-, hunde- eller katte-afledte, og epitoppeptiderne er afledt fra nativt menneske-, katte- og hundeprotein eller syntetiseres kemisk in vitro.
4. Sammensætning ifølge krav 3, hvor den anførte epitopsekvens fra insulin refererer til sekvens 1 eller sekvens 2 eller sekvens 3 eller sekvens 12 eller sekvens 13; det anførte epitoppeptid fra hundeinsulin henviser til sekvens 4 eller sekvens 5 eller sekvens 12 eller sekvens 13; det anførte epitoppeptid fra katteinsulin henviser til sekvens 6 eller sekvens 7 eller sekvens 12 eller sekvens 13.
5. Sammensætning ifølge krav 1-4 til anvendelse i en fremgangsmåde til behandling af type 1 diabetes og/eller forebyggelse.
6. Sammensætning ifølge krav 1-5 til anvendelse i en fremgangsmåde til behandling og/eller forebyggelse af TID, der vedrører mindst én af de nedenfor anførte anvendelser: (1) At forøge forholdet mellem CD4+ CD25+ Treg-celler og CD4+T-celler; (2) At forbedre proliferationen af CD4+ CD25+ Treg-celler; (3) At forøge IL-10-sekretionen fra T-celler; (4) At regulere blodsukkeret hos TI D patienter; (5) At inhibere cytotoksicitetsvirkningen af auto-reaktive CD8+ T-celler; (6) At opregulere transkriptionsniveauet af IL-10 og/eller TGF-β i PBMC og/eller milt;
(7) At inhibere DC-modning;
(8) At formindske ekspressionen af mindst ét af proteinerne CD40, CD80, CD83, CD86 i DC.
DK13785267.9T 2012-04-13 2013-04-12 Farmaceutisk sammensætning til behandling og/eller forebyggelse af type i-diabetes og anvendelse deraf DK2842568T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201210108159.6A CN103372214B (zh) 2012-04-13 2012-04-13 治疗和/或预防ⅰ型糖尿病的药物组合物及其应用
PCT/CN2013/000429 WO2013163887A1 (zh) 2012-04-13 2013-04-12 治疗和/或预防ⅰ型糖尿病的药物组合物及其应用

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US (1) US20150140007A1 (da)
EP (1) EP2842568B1 (da)
CN (2) CN106668852B (da)
DK (1) DK2842568T3 (da)
WO (1) WO2013163887A1 (da)

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CN104327163B (zh) * 2014-09-28 2017-03-22 刘旭 胰岛素淀粉样多肽抑制剂及其制备方法、应用
WO2019002364A1 (en) * 2017-06-28 2019-01-03 Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH) METHOD OF DETERMINING THE RISK OF DEVELOPING TYPE 1 DIABETES
CN109970863A (zh) * 2017-12-28 2019-07-05 南京零一生物科技有限公司 一种具有降糖及免疫调节作用的双功能多肽及其用途
WO2020232247A1 (en) 2019-05-14 2020-11-19 Provention Bio, Inc. Methods and compositions for preventing type 1 diabetes
CN112933216B (zh) * 2019-12-24 2023-04-28 艾棣维欣(苏州)生物制药有限公司 同时含有胰岛素和地塞米松磷酸钠的稳定的药物组合物
BR112022025381A2 (pt) 2020-06-11 2023-01-24 Provention Bio Inc Métodos e composições para prevenir diabetes tipo 1
CN112426524A (zh) * 2020-12-21 2021-03-02 中国医学科学院生物医学工程研究所 植物性多糖作为佐剂在制备自身性免疫疾病药物中的应用
CN113925960B (zh) * 2021-08-31 2022-10-28 苏州尔生生物医药有限公司 一种预防或治疗i型糖尿病的疫苗系统及其制备方法
KR20240049848A (ko) * 2021-09-08 2024-04-17 인티그레이티드 나노테라퓨틱스 아이엔씨. 항원과 약물-지질 접합체의 면역조절 조합
CN115850486B (zh) * 2022-11-16 2023-05-30 艾可泰科(浙江)控股有限公司 胰岛干细胞在治疗糖尿病中的用途
CN116284391B (zh) * 2022-11-16 2023-08-08 艾可泰科(浙江)控股有限公司 使用胰岛干细胞和抗体治疗糖尿病

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US7485314B2 (en) * 2002-05-06 2009-02-03 Los Angeles Biomedical Research Institute At Harbor-Ucla Medical Center Induction of antigen specific immunologic tolerance
US7232828B2 (en) * 2002-08-10 2007-06-19 Bethesda Pharmaceuticals, Inc. PPAR Ligands that do not cause fluid retention, edema or congestive heart failure
JP2007520566A (ja) * 2004-02-04 2007-07-26 ザ トラスティーズ オブ コロンビア ユニヴァーシティ イン ザ シティ オブ ニューヨーク 自己免疫治療のための抗cd3及び抗原特異的免疫療法
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WO2013163887A1 (zh) 2013-11-07
US20150140007A1 (en) 2015-05-21
CN106668852B (zh) 2020-12-25
CN106668852A (zh) 2017-05-17
EP2842568B1 (en) 2018-11-14
EP2842568A4 (en) 2016-03-30
CN103372214A (zh) 2013-10-30
CN103372214B (zh) 2017-09-29
EP2842568A1 (en) 2015-03-04

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