BR112014017111A2 - métodos de redução de imunogenicidade contra o fator viii em indivíduos submetidos à terapia de fator viii - Google Patents

métodos de redução de imunogenicidade contra o fator viii em indivíduos submetidos à terapia de fator viii

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Publication number
BR112014017111A2
BR112014017111A2 BR112014017111A BR112014017111A BR112014017111A2 BR 112014017111 A2 BR112014017111 A2 BR 112014017111A2 BR 112014017111 A BR112014017111 A BR 112014017111A BR 112014017111 A BR112014017111 A BR 112014017111A BR 112014017111 A2 BR112014017111 A2 BR 112014017111A2
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BR
Brazil
Prior art keywords
fviii
factor viii
chimeric
methods
deletion
Prior art date
Application number
BR112014017111A
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English (en)
Other versions
BR112014017111A8 (pt
Inventor
Jiang Haiyan
Josephson Neil
Glenn Pierce
krishnamoorthy Sriram
Liu Tongyao
Original Assignee
Biogen Idec Inc
Puget Sound Blood Center
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Biogen Idec Inc, Puget Sound Blood Center filed Critical Biogen Idec Inc
Publication of BR112014017111A2 publication Critical patent/BR112014017111A2/pt
Publication of BR112014017111A8 publication Critical patent/BR112014017111A8/pt

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • 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
    • A61K39/0005—Vertebrate antigens
    • A61K39/0008—Antigens related to auto-immune diseases; Preparations to induce self-tolerance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
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    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6815—Enzymes
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    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
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    • C07K2319/00—Fusion polypeptide
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    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers

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Abstract

abstract the present disclosure provides methods of administering chimeric and hybrid factor viii (fviii) polypeptides comprising fviii and fc to subjects at risk of developing inhibitory fviii immune responses, including anti-fviii antibodies and/or cell-mediated immunity. the administration is sufficient to promote coagulation and to induce immune tolerance to fviii. the chimeric polypeptide can comprise full-length fviii or a fviii polypeptide containing a deletion, e.g., a full or partial deletion of the b domain. ___________________ tradução do resumo resumo patente de invenção: "métodos de redução de imunogeni-cidade contra o fator viii em indivíduos submetidos à terapia de fator viii". a presente divulgação fornece métodos de administrar qui-méricos e polipeptídeos do fator viii (fviii) híbrido que é compreendi-do por fviii e fc ao sujeito em risco de desenvolvimento de resposta imune inibitória de fviii, incluindo anticorpos anti-fviii e/ou imunidade mediada por células. a administração é suficiente para promover a co-agulação e para induzir a tolerância imunológica de fviii. o polipeptí-deo quimérico pode compreender fviii com comprimento total ou um polipeptídeo fviii contendo uma deleção, por exemplo, uma deleção total ou parcial do domínio b.
BR112014017111A 2012-01-12 2013-01-12 métodos de redução de imunogenicidade contra o fator viii em indivíduos submetidos à terapia de fator viii BR112014017111A8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261586103P 2012-01-12 2012-01-12
US201261668961P 2012-07-06 2012-07-06
PCT/US2013/021332 WO2013106789A1 (en) 2012-01-12 2013-01-12 Methods of reducing immunogenicity against factor viii in individuals undergoing factor viii therapy

Publications (2)

Publication Number Publication Date
BR112014017111A2 true BR112014017111A2 (pt) 2017-06-13
BR112014017111A8 BR112014017111A8 (pt) 2018-05-15

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ID=48781969

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BR112014017111A BR112014017111A8 (pt) 2012-01-12 2013-01-12 métodos de redução de imunogenicidade contra o fator viii em indivíduos submetidos à terapia de fator viii

Country Status (22)

Country Link
US (3) US10221455B2 (pt)
EP (3) EP3970737A1 (pt)
JP (4) JP6234378B2 (pt)
CN (2) CN108465106B (pt)
AU (2) AU2016210768B2 (pt)
BR (1) BR112014017111A8 (pt)
CA (1) CA2863329C (pt)
CY (1) CY1121157T1 (pt)
DK (1) DK2802668T3 (pt)
EA (2) EA038705B1 (pt)
ES (2) ES2700583T3 (pt)
HR (1) HRP20181714T1 (pt)
HU (1) HUE041595T2 (pt)
IL (1) IL233565B (pt)
LT (1) LT2802668T (pt)
NZ (1) NZ627078A (pt)
PL (2) PL3453402T3 (pt)
PT (2) PT3453402T (pt)
RS (1) RS57936B1 (pt)
SI (1) SI2802668T1 (pt)
TR (1) TR201816253T4 (pt)
WO (1) WO2013106789A1 (pt)

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SI2802668T1 (sl) * 2012-01-12 2019-01-31 Bioverativ Therapeutics Inc. Zmanjšanje imunogeničnosti proti faktorju VIII pri posameznikih, ki se zdravijo zaradi faktorja VIII
WO2014070953A1 (en) * 2012-10-30 2014-05-08 Biogen Idec Ma Inc. Methods of Using FVIII Polypeptide
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HUE050869T2 (hu) * 2013-11-15 2021-01-28 Univ Pennsylvania Készítmények VIII-as faktorral szembeni inhibitorképzõdés szuppresszálására A-típusú hemofíliás betegekben
US20170128544A1 (en) * 2014-06-12 2017-05-11 University Of Hawaii Uses of Humanized Cobra Venom Factor for Reducing or Preventing Immunogenicity
JP6695426B2 (ja) * 2015-11-13 2020-05-20 バクスアルタ インコーポレイテッド 組換えｆｖｉｉｉ変異型をコードする血友病ａ遺伝子治療用高発現ウイルスベクター
KR20230008256A (ko) * 2015-11-13 2023-01-13 다케다 야쿠힌 고교 가부시키가이샤 A형 혈우병의 유전자 요법을 위한 증가된 발현을 갖는 재조합 fviii 변이체를 인코딩하는 바이러스 벡터
RU2647769C2 (ru) * 2015-12-30 2018-03-19 Закрытое Акционерное Общество "Биокад" Химерный улучшенный рекомбинантный фактор VIII
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WO2017155981A1 (en) * 2016-03-07 2017-09-14 Massachusetts Institute Of Technology Protein-chaperoned t-cell vaccines
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CN106279437B (zh) * 2016-08-19 2017-10-31 安源医药科技（上海）有限公司 高糖基化人凝血因子viii融合蛋白及其制备方法与用途
CN110520149A (zh) * 2016-12-02 2019-11-29 比奥维拉迪维治疗股份有限公司 诱导对凝血因子的免疫耐受性的方法
EP3548066A1 (en) 2016-12-02 2019-10-09 Bioverativ Therapeutics Inc. Methods of treating hemophilic arthropathy using chimeric clotting factors
US20210163986A1 (en) 2017-08-09 2021-06-03 Bioverativ Therapeutics Inc. Nucleic acid molecules and uses thereof
JP2021523878A (ja) 2018-05-18 2021-09-09 バイオベラティブ セラピューティクス インコーポレイテッド 血友病ａを処置する方法
CA3106590A1 (en) 2018-07-16 2020-01-23 Baxalta Incorporated Gene therapy of hemophilia a using viral vectors encoding recombinant fviii variants with increased expression
US20200069817A1 (en) 2018-08-09 2020-03-05 Bioverativ Therapeutics Inc. Nucleic acid molecules and uses thereof for non-viral gene therapy
CN113105562B (zh) 2018-09-26 2023-12-01 安源医药科技（上海）有限公司 突变型单链人凝血因子viii在制备融合蛋白中的应用
CA3127065A1 (en) 2019-01-16 2020-07-23 Baxalta Incorporated Viral vectors encoding recombinant fviii variants with increased expression for gene therapy of hemophilia a
JP2022531095A (ja) 2019-04-17 2022-07-06 コディアック バイオサイエンシーズ， インコーポレイテッド エキソソーム及びａａｖの組成物
CA3144630A1 (en) 2019-06-19 2020-12-24 Bioverativ Therapeutics Inc. Methods and compositions for treating hemophilia and low bone mineral density with factor viiifc protein
EP4016078A1 (en) * 2020-12-18 2022-06-22 Rheinische Friedrich-Wilhelms-Universität Bonn Method useful in tolerance induction therapy and kits therefore

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