EA201100809A1 - NEW functionally active, highly purified, stable Alpha interferon conjugate with polyethylene glycol, represented by one of positional isomers of PEG-NαH-IFN, with a reduced immunogenicity, with a prolonged biological effect are suitable for medical applications, and immunobiological agent based on ITS - Google Patents

NEW functionally active, highly purified, stable Alpha interferon conjugate with polyethylene glycol, represented by one of positional isomers of PEG-NαH-IFN, with a reduced immunogenicity, with a prolonged biological effect are suitable for medical applications, and immunobiological agent based on ITS

Info

Publication number
EA201100809A1
EA201100809A1 EA201100809A EA201100809A EA201100809A1 EA 201100809 A1 EA201100809 A1 EA 201100809A1 EA 201100809 A EA201100809 A EA 201100809A EA 201100809 A EA201100809 A EA 201100809A EA 201100809 A1 EA201100809 A1 EA 201100809A1
Authority
EA
Eurasian Patent Office
Prior art keywords
conjugate
ifn
peg
polyethylene glycol
highly purified
Prior art date
Application number
EA201100809A
Other languages
Russian (ru)
Other versions
EA020257B1 (en
Inventor
Татьяна Вениаминовна ЧЕРНОВСКАЯ
Лев Александрович Денисов
Дмитрий Валентинович МОРОЗОВ
Елена Георгиевна Руденко
Ангелина Всеволодовна Кленова
Original Assignee
Закрытое Акционерное Общество "Биокад"
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.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=45497062&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA201100809(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Закрытое Акционерное Общество "Биокад" filed Critical Закрытое Акционерное Общество "Биокад"
Publication of EA201100809A1 publication Critical patent/EA201100809A1/en
Publication of EA020257B1 publication Critical patent/EA020257B1/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/555—Interferons [IFN]
    • C07K14/56—IFN-alpha
    • 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]
    • 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
    • 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
    • A61K47/56—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • 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
    • A61P37/02—Immunomodulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Oncology (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Communicable Diseases (AREA)
  • Zoology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Hematology (AREA)
  • Biotechnology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Изобретение относится к области фармацевтической промышленности и медицины, в частности к новым ПЭГ-производным интерферонов, и касается создания нового функционально активного, высокоочищенного, стабильного коньюгата интерферона с полиэтиленгликолем с активностью интерферона альфа, с уменьшенной иммуногенностью, с пролонгированным биологическим действием, улучшенными фармакокинетическими параметрами общей формулыгде: n - целые значения от 227 до 10000, так что молекулярная масса ПЭГ составляет примерно 10000-40000 Да; m - целое число ≥ 4; IFN - природный или рекомбинантный полипептид, обладающий активностью ИФН-альфа. Также изобретение относится к лекарственным средствам, содержащим заявляемый коньюгат формулы (I), фармацевтическим композициям, пригодным для лечения вирусных и онкологических заболеваний и заболеваний, сопровождающихся первичными или вторичными иммунодефицитными состояниями, содержащим заявляемый коньюгат ПЭГ-ИФН и терапевтически приемлемые вспомогательные компоненты. Изобретение относится к применению коньюгата формулы (I) для получения лекарственного средства, обладающего противовирусной, антипролиферативной и иммуномодулирующей активностью, способу профилактики и/или лечения заболеваний, сопровождающихся первичными или вторичными иммунодефицитными состояниями, включающему введение терапевтически эффективного количества коньюгата формулы (I), контейнеру, включающему фармацевтическую композицию, и набору.The invention relates to the field of pharmaceutical industry and medicine, in particular to new PEG-derived interferons, and concerns the creation of a new functionally active, highly purified, stable interferon conjugate with polyethylene glycol with interferon alpha activity, with reduced immunogenicity, with prolonged biological effect, improved pharmacokinetic parameters formulas where: n - integer values from 227 to 10,000, so that the molecular weight of the PEG is approximately 10,000 to 4,000,000 Da; m is an integer ≥ 4; IFN is a natural or recombinant polypeptide with an IFN-alpha activity. The invention also relates to medicinal products containing the claimed conjugate of formula (I), pharmaceutical compositions suitable for the treatment of viral and oncological diseases and diseases accompanied by primary or secondary immunodeficiency states, containing the claimed conjugate PEG-IFN and therapeutically acceptable auxiliary components. The invention relates to the use of a conjugate of formula (I) for the preparation of a drug having antiviral, antiproliferative and immunomodulatory activity, a method of preventing and / or treating diseases involving primary or secondary immunodeficiency states, including the administration of a therapeutically effective amount of a conjugate of formula (I), a container, comprising a pharmaceutical composition, and a kit.

EA201100809A 2010-07-20 2011-06-21 THE NEW STABLE POLYETHYLENE GLYCOL CONJUGATE OF INTERFERON ALPHA, REPRESENTED BY ONE POSITIONAL ISOMER PEF-NαH-IFN AND IMMUNOBIOLOGIC PREPARATION BASED THEREON EA020257B1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
RU2010129824/10A RU2447083C1 (en) 2010-07-20 2010-07-20 NOVEL FUNCTIONALLY ACTIVE, HIGHLY PURE, STABLE CONJUGATE OF INTERFERON α WITH POLYETHYLENE GLYCOL, REPRESENTED BY ONE PEG- NαH-IFN POSITIONAL ISOMER, WITH IMPROVED IMMUNOGENICITY, WITH PROLONGED BIOLOGICAL ACTION, SUITABLE FOR MEDICAL APPLICATION, AND IMMUNOLOGICAL AGENT BASED THEREON

Publications (2)

Publication Number Publication Date
EA201100809A1 true EA201100809A1 (en) 2012-01-30
EA020257B1 EA020257B1 (en) 2014-09-30

Family

ID=45497062

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201100809A EA020257B1 (en) 2010-07-20 2011-06-21 THE NEW STABLE POLYETHYLENE GLYCOL CONJUGATE OF INTERFERON ALPHA, REPRESENTED BY ONE POSITIONAL ISOMER PEF-NαH-IFN AND IMMUNOBIOLOGIC PREPARATION BASED THEREON

Country Status (20)

Country Link
KR (1) KR101586372B1 (en)
CN (1) CN102617736B (en)
AR (1) AR087227A1 (en)
BR (1) BRPI1101565A2 (en)
CO (1) CO6680611A2 (en)
CR (1) CR20130021A (en)
CU (1) CU24193B1 (en)
DO (1) DOP2013000002A (en)
EA (1) EA020257B1 (en)
EC (1) ECSP13012398A (en)
HK (1) HK1170504A1 (en)
MX (1) MX2011007458A (en)
MY (1) MY168784A (en)
NI (1) NI201300008A (en)
PE (1) PE20131034A1 (en)
RU (1) RU2447083C1 (en)
SG (1) SG187117A1 (en)
UA (1) UA99766C2 (en)
UY (1) UY33525A (en)
WO (1) WO2012011836A1 (en)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2515913C1 (en) * 2013-03-22 2014-05-20 Федеральное государственное унитарное предприятие "Государственный научно-исследовательский институт генетики и селекции промышленных микроорганизмов" (ФГУП "ГосНИИгенетика") HYBRID PROTEIN HAVING PROLONGED ACTION, BASED ON RECOMBINANT HUMAN INTERFERON ALPHA-2 (VARIANTS), METHOD OF ITS PRODUCTION AND STRAIN OF Saccharomyces cerevisiae FOR IMPLEMENTING THIS METHOD (VERSIONS)
EA021610B1 (en) * 2013-03-28 2015-07-30 Илья Александрович МАРКОВ Liquid antiviral formulation
EA021643B1 (en) * 2013-03-28 2015-07-30 Илья Александрович МАРКОВ Monopegylated interferon-alpha of linear structure and a pharmaceutical composition for preparing a medicament having interferon-alpha activity
CN103463623B (en) * 2013-09-03 2015-09-09 长春海伯尔生物技术有限责任公司 A kind of Peg-IFN alpha-2b injection and preparation method thereof
RU2554761C1 (en) * 2014-05-13 2015-06-27 Закрытое акционерное общество "Сибирский центр фармакологии и биотехнологии" Anti-enteroviral and immunostimulating agent
RU2572800C1 (en) * 2014-09-22 2016-01-20 Закрытое Акционерное Общество "Биокад" New formulation containing polyethylene glycol (peg) conjugated interferon alpha-2beta characterised by less painful administration
EA029498B1 (en) * 2015-11-24 2018-04-30 Учреждение Белорусского государственного университета "Научно-исследовательский институт физико-химических проблем" (НИИ ФХП БГУ) ANTI-TUMOUR DRUG BASED ON RECOMBINANT INTERFERON ALPHA-2b IN THE FORM OF MICROPARTICLES FOR PARENTERAL ADMINISTRATION
RU2678332C1 (en) 2017-09-08 2019-01-28 Общество с ограниченной ответственностью "Саентифик Фьючер Менеджмент" (ООО "СФМ") Pegylated interferon lambda with high bioaccessability in oral use and method for production thereof
WO2021212220A1 (en) * 2020-04-20 2021-10-28 Altum Pharmaceuticals Inc. Recombinant interferon
CN114392237B (en) * 2021-12-28 2024-02-02 上海允英生物医药科技有限公司 Freeze-dried virus preparation and preparation method thereof

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5951974A (en) * 1993-11-10 1999-09-14 Enzon, Inc. Interferon polymer conjugates
US20030053982A1 (en) * 1994-09-26 2003-03-20 Kinstler Olaf B. N-terminally chemically modified protein compositions and methods
JP2758154B2 (en) * 1995-04-06 1998-05-28 エフ・ホフマン−ラ ロシユ アーゲー Liquid preparations containing interferon
TW517067B (en) * 1996-05-31 2003-01-11 Hoffmann La Roche Interferon conjugates
RS20050202A (en) * 2002-09-09 2007-08-03 Nektar Therapeuticals Al.Corporation, Water-soluble polymer alkanals
RU2311930C2 (en) * 2004-04-30 2007-12-10 Закрытое акционерное общество "ВЕРОФАРМ" Pagylated interferon against viral infection
AU2005260664A1 (en) * 2004-06-30 2006-01-12 Egen Corporation Pegylated interferon alpha-1b
JP5600240B2 (en) * 2005-07-19 2014-10-01 ウェルズ ファーゴ バンク ナショナル アソシエイション Process for preparing polymeric maleimides
US8840882B2 (en) * 2006-06-23 2014-09-23 Quintessence Biosciences, Inc. Modified ribonucleases
CN101491682A (en) * 2008-04-30 2009-07-29 北京凯正生物工程发展有限责任公司 PEG-IFN omega conjugate and preparation technique thereof
CN101591387A (en) * 2008-05-28 2009-12-02 中国人民解放军军事医学科学院微生物流行病研究所 PEG-IFN omega conjugate
CN101514229B (en) * 2009-04-03 2012-05-09 海南四环心脑血管药物研究院有限公司 Human interferon alpha derivative and polyethylene glycol modified substance thereof

Also Published As

Publication number Publication date
RU2447083C1 (en) 2012-04-10
WO2012011836A1 (en) 2012-01-26
AR087227A1 (en) 2014-03-12
RU2010129824A (en) 2012-01-27
CN102617736A (en) 2012-08-01
CR20130021A (en) 2013-02-20
MX2011007458A (en) 2012-01-19
KR20130056885A (en) 2013-05-30
DOP2013000002A (en) 2013-09-15
ECSP13012398A (en) 2013-05-31
BRPI1101565A2 (en) 2012-12-04
CO6680611A2 (en) 2013-05-31
CU24193B1 (en) 2016-09-30
CU20130013A7 (en) 2013-04-19
CN102617736B (en) 2015-11-25
UA99766C2 (en) 2012-09-25
EA020257B1 (en) 2014-09-30
UY33525A (en) 2012-02-29
NI201300008A (en) 2014-05-26
KR101586372B1 (en) 2016-01-18
PE20131034A1 (en) 2013-09-27
MY168784A (en) 2018-12-04
SG187117A1 (en) 2013-02-28
HK1170504A1 (en) 2013-03-01

Similar Documents

Publication Publication Date Title
EA201100809A1 (en) NEW functionally active, highly purified, stable Alpha interferon conjugate with polyethylene glycol, represented by one of positional isomers of PEG-NαH-IFN, with a reduced immunogenicity, with a prolonged biological effect are suitable for medical applications, and immunobiological agent based on ITS
Rohrer et al. Advanced formulations for intranasal delivery of biologics
MX2012007410A (en) Novel antiviral compounds.
EA201171376A1 (en) THYENO DERIVATIVES [2,3-B] PIRIDINE AS VIRUS REPLICATION INHIBITORS
MD4430C1 (en) Compositions and methods for treating hepatitis C virus
MX2013005478A (en) Antiviral condensed heterocyclic compounds.
EA201290395A1 (en) IMMUNOMODULATING POLYPEPTIDES OBTAINED FROM IL-2 AND THEIR USE FOR THE TREATMENT OF CANCER AND CHRONIC INFECTIONS
EA201101035A1 (en) NEW CONJUGATE OF GRANULOCITAR COLONIUS STIMULATION FACTOR (G-CSF) WITH POLYETHYLENE GLYCOL
MX2010002557A (en) Polyethylene glycol modified interferon alpha 2b and preparation method and applicatioins thereof.
EA009995B1 (en) Human serum albumin-free stabilized interferon liquid formulations
NZ701205A (en) Optimised subcutaneous therapeutic agents
WO2022081711A4 (en) Lipopeptide fusion inhibitors as sars-cov-2 antivirals
BR112022010574A2 (en) PHARMACEUTICAL COMPOSITIONS INCLUDING CABOTEGRAVIR
JP2013542196A5 (en)
AU2005244826B2 (en) Treatment or prevention of respiratory viral infections with immunomodulator compounds
RU2140285C1 (en) Antiviral agent - nasal drops "grippferon"
RU2013129824A (en) NEW TREATMENT OF HEPATITIS C VIRUS INFECTION
RU2572800C1 (en) New formulation containing polyethylene glycol (peg) conjugated interferon alpha-2beta characterised by less painful administration
JP2015524808A5 (en)
RU2554495C2 (en) Cytokine-containing medication, possessing antiviral, antimicrobial, immunomodulating and anti-inflammatory action for prevention and treatment of infection diseases
MX2023001572A (en) Solid dosage forms of palbociclib.
RU2014116988A (en) ALISPORIVIR FOR TREATING INFECTIONS CAUSED BY HEPATITIS C VIRUS
TH133837A (en)
RU2014140049A (en) MOLECULE interferon-β-1a HUMAN pegylated, possess antiviral, immunomodulating and antiproliferative activity, with improved stability, reduced immunogenicity, improved pharmacokinetic and pharmacodynamic parameters suitable for medical applications, and immunobiological BEING ON ITS BASIS
RU2013158037A (en) MOLECULE interferon-β-1a HUMAN pegylated, possess antiviral, immunomodulating and antiproliferative activity, with improved stability, reduced immunogenicity, improved pharmacokinetic and pharmacodynamic parameters suitable for medical applications, and immunobiological BEING ON ITS BASIS

Legal Events

Date Code Title Description
MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ BY KZ KG MD TJ TM RU