CO2021016183A2 - Formulaciones estabilizadas que contienen anticuerpos anti-angptl3 - Google Patents

Formulaciones estabilizadas que contienen anticuerpos anti-angptl3

Info

Publication number
CO2021016183A2
CO2021016183A2 CONC2021/0016183A CO2021016183A CO2021016183A2 CO 2021016183 A2 CO2021016183 A2 CO 2021016183A2 CO 2021016183 A CO2021016183 A CO 2021016183A CO 2021016183 A2 CO2021016183 A2 CO 2021016183A2
Authority
CO
Colombia
Prior art keywords
angptl3
formulations containing
antibody
containing anti
stabilized formulations
Prior art date
Application number
CONC2021/0016183A
Other languages
English (en)
Inventor
Dingjiang Liu
Andria Skinner
Original Assignee
Regeneron Pharma
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
Application filed by Regeneron Pharma filed Critical Regeneron Pharma
Publication of CO2021016183A2 publication Critical patent/CO2021016183A2/es

Links

Classifications

    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La presente invención provee formulaciones farmacéuticas estables que comprenden un anticuerpo humano que se une específicamente a la proteína 3 similar a la angiopoyetina humana (ANGPTL3). Las formulaciones pueden contener, además de un anticuerpo anti-ANGPTL3, un regulador de pH; un co-disolvente orgánico; al menos un modificador de viscosidad y opcionalmente al menos un aminoácido. Las formulaciones farmacéuticas de la presente invención se pueden administrar mediante infusión intravenosa o subcutáneamente y presentan un grado sustancial de estabilidad de anticuerpos después de su almacenamiento durante varios meses.
CONC2021/0016183A 2019-05-24 2021-11-29 Formulaciones estabilizadas que contienen anticuerpos anti-angptl3 CO2021016183A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962852643P 2019-05-24 2019-05-24
PCT/US2020/034438 WO2020243031A1 (en) 2019-05-24 2020-05-24 Stabilized formulations containing anti-angptl3 antibodies

Publications (1)

Publication Number Publication Date
CO2021016183A2 true CO2021016183A2 (es) 2021-12-10

Family

ID=72179136

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2021/0016183A CO2021016183A2 (es) 2019-05-24 2021-11-29 Formulaciones estabilizadas que contienen anticuerpos anti-angptl3

Country Status (16)

Country Link
US (1) US20200369760A1 (es)
EP (1) EP3976647A1 (es)
JP (1) JP2022532927A (es)
KR (1) KR20220011727A (es)
CN (1) CN114007647A (es)
AU (1) AU2020282956A1 (es)
BR (1) BR112021023501A2 (es)
CA (1) CA3139333A1 (es)
CL (1) CL2021003026A1 (es)
CO (1) CO2021016183A2 (es)
EA (1) EA202193240A1 (es)
IL (1) IL288153A (es)
MA (1) MA56049A (es)
MX (1) MX2021014332A (es)
SG (1) SG11202112256SA (es)
WO (1) WO2020243031A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3412B1 (ar) * 2011-06-17 2019-10-20 Regeneron Pharma أجسام مضادة ل angptl3 واستخداماتها
KR20240035835A (ko) * 2021-07-21 2024-03-18 지앙수 헨그루이 파마슈티컬스 컴퍼니 리미티드 항-angptl3 항체 또는 이의 항원 결합 단편의 약학적 조성물 및 이의 응용
MX2024007900A (es) 2021-12-22 2024-07-10 Regeneron Pharma Tratamiento de enfermedades renales con inhibidores de la angiopoyetina tipo 3 (angptl3).
WO2023213779A1 (en) 2022-05-02 2023-11-09 Novo Nordisk A/S Novel anti-angptl3 antibodies suitable for high concentration compositions and subcutaneous administration
WO2024102913A1 (en) 2022-11-10 2024-05-16 Regeneron Pharmaceuticals, Inc. Treatment of kidney diseases with a combination of angiopoietin like 3 (angptl3) inhibitors and solute carrier family 5 member 2 (slc5a2) inhibitors

Family Cites Families (12)

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Publication number Priority date Publication date Assignee Title
JPH0747045B2 (ja) 1986-10-15 1995-05-24 株式会社大協精工 積層した注射器用滑栓
JP3100727B2 (ja) 1992-01-23 2000-10-23 株式会社大協精工 変性ポリシロキサン組成物及び該組成物を被覆した衛生ゴム製品
JP3172057B2 (ja) 1995-04-05 2001-06-04 株式会社大協精工 ラミネートゴム栓
JP3512349B2 (ja) 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
US6629949B1 (en) 2000-05-08 2003-10-07 Sterling Medivations, Inc. Micro infusion drug delivery device
JP2002209975A (ja) 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓
CN101855241B (zh) 2006-12-08 2013-11-06 莱克康制药公司 针对angptl3的单克隆抗体
AR070315A1 (es) * 2008-02-07 2010-03-31 Merck & Co Inc Anticuerpos 1b20 antagonistas de pcsk9
JO3412B1 (ar) 2011-06-17 2019-10-20 Regeneron Pharma أجسام مضادة ل angptl3 واستخداماتها
EP2735315B1 (en) * 2011-07-19 2019-10-02 Chugai Seiyaku Kabushiki Kaisha Stable protein-containing preparation containing argininamide or valinamide
US11603407B2 (en) * 2017-04-06 2023-03-14 Regeneron Pharmaceuticals, Inc. Stable antibody formulation

Also Published As

Publication number Publication date
CN114007647A (zh) 2022-02-01
WO2020243031A1 (en) 2020-12-03
SG11202112256SA (en) 2021-12-30
JP2022532927A (ja) 2022-07-20
CA3139333A1 (en) 2020-12-03
EP3976647A1 (en) 2022-04-06
KR20220011727A (ko) 2022-01-28
EA202193240A1 (ru) 2022-03-14
IL288153A (en) 2022-01-01
CL2021003026A1 (es) 2022-06-24
BR112021023501A2 (pt) 2022-01-18
US20200369760A1 (en) 2020-11-26
MX2021014332A (es) 2022-04-06
AU2020282956A1 (en) 2022-01-27
MA56049A (fr) 2022-04-06

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