BR112020003498A2 - composições farmacêuticas e regimes de dosagem que contêm anticorpos anti-alfa(v)beta(6) - Google Patents

composições farmacêuticas e regimes de dosagem que contêm anticorpos anti-alfa(v)beta(6) Download PDF

Info

Publication number
BR112020003498A2
BR112020003498A2 BR112020003498-3A BR112020003498A BR112020003498A2 BR 112020003498 A2 BR112020003498 A2 BR 112020003498A2 BR 112020003498 A BR112020003498 A BR 112020003498A BR 112020003498 A2 BR112020003498 A2 BR 112020003498A2
Authority
BR
Brazil
Prior art keywords
αvβ6
seq
concentration
amino acid
acid sequence
Prior art date
Application number
BR112020003498-3A
Other languages
English (en)
Portuguese (pt)
Inventor
Tia Brie Estey
Geetha Govindan
Sonal Saluja
Kapil Gupta
Margaret McGrath
Original Assignee
Biogen Ma, Inc.
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 Biogen Ma, Inc. filed Critical Biogen Ma, Inc.
Publication of BR112020003498A2 publication Critical patent/BR112020003498A2/pt

Links

Classifications

    • 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
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • C07K16/2839Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C07K16/2842Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta1-subunit-containing molecules, e.g. CD29, CD49
    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4418Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
    • 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • 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
    • C07K16/2839Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/524CH2 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/526CH3 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
BR112020003498-3A 2017-08-22 2018-08-22 composições farmacêuticas e regimes de dosagem que contêm anticorpos anti-alfa(v)beta(6) BR112020003498A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762548772P 2017-08-22 2017-08-22
US62/548,772 2017-08-22
PCT/US2018/047502 WO2019040608A1 (en) 2017-08-22 2018-08-22 PHARMACEUTICAL COMPOSITIONS AND DOSAGE SCHEMES CONTAINING ANTI-ALPHA (V) BETA ANTIBODIES (6)

Publications (1)

Publication Number Publication Date
BR112020003498A2 true BR112020003498A2 (pt) 2020-08-25

Family

ID=63452750

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112020003498-3A BR112020003498A2 (pt) 2017-08-22 2018-08-22 composições farmacêuticas e regimes de dosagem que contêm anticorpos anti-alfa(v)beta(6)

Country Status (11)

Country Link
US (1) US20210363259A1 (enExample)
EP (1) EP3672632A1 (enExample)
JP (1) JP2020531521A (enExample)
KR (1) KR20200044066A (enExample)
CN (1) CN111201036A (enExample)
AU (1) AU2018322475A1 (enExample)
BR (1) BR112020003498A2 (enExample)
CA (1) CA3073286A1 (enExample)
MA (1) MA49948A (enExample)
MX (1) MX2020001851A (enExample)
WO (1) WO2019040608A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7551750B2 (ja) * 2019-12-05 2024-09-17 シージェン インコーポレイテッド 抗αvβ6抗体及び抗体薬物コンジュゲート

Family Cites Families (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5179017A (en) 1980-02-25 1993-01-12 The Trustees Of Columbia University In The City Of New York Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials
US4399216A (en) 1980-02-25 1983-08-16 The Trustees Of Columbia University Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials
US4634665A (en) 1980-02-25 1987-01-06 The Trustees Of Columbia University In The City Of New York Processes for inserting DNA into eucaryotic cells and for producing proteinaceous materials
US4475196A (en) 1981-03-06 1984-10-02 Zor Clair G Instrument for locating faults in aircraft passenger reading light and attendant call control system
US4447233A (en) 1981-04-10 1984-05-08 Parker-Hannifin Corporation Medication infusion pump
US4439196A (en) 1982-03-18 1984-03-27 Merck & Co., Inc. Osmotic drug delivery system
US4447224A (en) 1982-09-20 1984-05-08 Infusaid Corporation Variable flow implantable infusion apparatus
US4487603A (en) 1982-11-26 1984-12-11 Cordis Corporation Implantable microinfusion pump system
US4486194A (en) 1983-06-08 1984-12-04 James Ferrara Therapeutic device for administering medicaments through the skin
US4596556A (en) 1985-03-25 1986-06-24 Bioject, Inc. Hypodermic injection apparatus
US4941880A (en) 1987-06-19 1990-07-17 Bioject, Inc. Pre-filled ampule and non-invasive hypodermic injection device assembly
US4790824A (en) 1987-06-19 1988-12-13 Bioject, Inc. Non-invasive hypodermic injection device
US5312335A (en) 1989-11-09 1994-05-17 Bioject Inc. Needleless hypodermic injection device
US5064413A (en) 1989-11-09 1991-11-12 Bioject, Inc. Needleless hypodermic injection device
US5383851A (en) 1992-07-24 1995-01-24 Bioject Inc. Needleless hypodermic injection device
US5827690A (en) 1993-12-20 1998-10-27 Genzyme Transgenics Corporatiion Transgenic production of antibodies in milk
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
ATE410179T1 (de) 1997-08-08 2008-10-15 Univ California Behandlung von leberfibrose mit anti-alpha v beta 6 integrin antikörpern
HRP20050934B1 (hr) * 2003-04-04 2014-09-26 Genentech, Inc. Formulacije s visokom koncentracijom antitijela i proteina
AU2005299716B2 (en) * 2004-10-22 2012-09-06 Amgen Inc. Methods for refolding of recombinant antibodies
GT200600031A (es) * 2005-01-28 2006-08-29 Formulacion anticuerpo anti a beta
CN104072614B (zh) * 2005-07-08 2017-04-26 生物基因Ma公司 抗-αvβ6 抗体及其用途
BRPI0710826A2 (pt) * 2006-04-21 2011-08-23 Novartis Ag composições farmacêuticas de anticorpo anti-cd40 antagonista
EP2087008A1 (en) * 2006-10-19 2009-08-12 The Regents of the University of California TREATMENT AND PREVENTION OF CHRONIC ASTHMA USING ANTAGONISTS OF INTEGRIN alphaVbeta6
TW200837080A (en) * 2007-01-09 2008-09-16 Wyeth Corp Anti-IL-13 antibody formulations and uses thereof
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
EP2538973A2 (en) * 2010-02-26 2013-01-02 Novo Nordisk A/S Stable antibody containing compositions
CA2831572C (en) * 2011-05-02 2019-11-26 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
HK1197159A1 (en) * 2011-05-25 2015-01-09 Intermune, Inc. Pirfenidone and anti-fibrotic therapy in selected patients
IL312865B2 (en) * 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
EP3383435A4 (en) * 2015-11-30 2019-07-10 Medimmune, LLC OPTIMIZED RATES OF AMINO ACIDS AND SUGARS AS AMORPHOUS STABILIZING COMPOUNDS IN PHARMACEUTICAL COMPOSITIONS HAVING HIGH CONCENTRATIONS IN PROTEIN-BASED THERAPEUTICS

Also Published As

Publication number Publication date
US20210363259A1 (en) 2021-11-25
AU2018322475A1 (en) 2020-03-05
CN111201036A (zh) 2020-05-26
WO2019040608A1 (en) 2019-02-28
KR20200044066A (ko) 2020-04-28
CA3073286A1 (en) 2019-02-28
EP3672632A1 (en) 2020-07-01
JP2020531521A (ja) 2020-11-05
MX2020001851A (es) 2020-08-20
MA49948A (fr) 2020-07-01

Similar Documents

Publication Publication Date Title
US11986526B2 (en) Liquid protein formulations containing 4-ethyl-4-methylmorpholinium methylcarbonate (EMMC)
ES2732243T3 (es) Composiciones farmacéuticas de anticuerpos ANTI-VLA1 (CD49A)
BRPI0814252B1 (pt) composição farmacêutica aquosa estável compreendendo natalizumabe, dose unitária, e seringa pré-cheia
KR20200128115A (ko) 항-pd-1 항체 조성물
US20200369760A1 (en) Stabilized formulations containing anti-angptl3 antibodies
BR112020003572A2 (pt) composições farmacêuticas contendo anticorpos anti-beta-amiloide
TW201400130A (zh) 包含抗-dll4抗體的穩定化調配物
BR112020003498A2 (pt) composições farmacêuticas e regimes de dosagem que contêm anticorpos anti-alfa(v)beta(6)
JP2025142195A (ja) 抗pd-1/her2二重特異性抗体を含む製剤及びその調製方法と使用
KR20250025681A (ko) 항-igf-1r 항체 조성물
US12472253B2 (en) Activin a antibody formulations and methods of use thereof
BR122024003611A2 (pt) Composições farmacêuticas, anticorpo anti-bdca2, uso do mesmo, e seringa ou bomba
JP2022524814A (ja) 抗lingo-1抗体を含む医薬組成物
HK40018131A (en) Liquid protein formulations containing ionic liquids
CN116763917A (zh) 一种稳定的抗人il15/pd-l1双功能融合蛋白制剂
BR112016005287B1 (pt) Formulação farmacêutica líquida para injeção e uso de um ou mais líquidos iônicos de redução de viscosidade
NZ756401B2 (en) Liquid protein formulations containing ionic liquids
NZ717918B2 (en) Liquid protein formulations containing ionic liquids

Legal Events

Date Code Title Description
B350 Update of information on the portal [chapter 15.35 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 5A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2737 DE 20/06/2023.