AR120309A1 - Formulaciones de polvo seco de anticuerpos que se unen a la linfopoyetina del estroma tímico (tslp) y métodos de uso de las mismas - Google Patents

Formulaciones de polvo seco de anticuerpos que se unen a la linfopoyetina del estroma tímico (tslp) y métodos de uso de las mismas

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Publication number
AR120309A1
AR120309A1 ARP200102963A ARP200102963A AR120309A1 AR 120309 A1 AR120309 A1 AR 120309A1 AR P200102963 A ARP200102963 A AR P200102963A AR P200102963 A ARP200102963 A AR P200102963A AR 120309 A1 AR120309 A1 AR 120309A1
Authority
AR
Argentina
Prior art keywords
amino acid
seq
set forth
acid sequence
sequence set
Prior art date
Application number
ARP200102963A
Other languages
English (en)
Inventor
Catherine Eugenie Chaillan Huntington
Susan Hoe
Prakash Manikwar
Roland Wilhelm Kolbeck
Emma Suzanne Cohen
Saba Ghazvini
David Lechuga-Ballesteros
Kellisa Beth Hansen
Dexter Joseph Dsa
Original Assignee
Medimmune Ltd
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 Medimmune Ltd filed Critical Medimmune Ltd
Publication of AR120309A1 publication Critical patent/AR120309A1/es

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Classifications

    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • 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
    • A61K47/26Carbohydrates, 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • 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
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • 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
    • 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
    • A61K2039/541Mucosal route
    • A61K2039/543Mucosal route intranasal
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/22Immunoglobulins specific features characterized by taxonomic origin from camelids, e.g. camel, llama or dromedary
    • 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
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
    • 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]
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Abstract

La presente tecnología se refiere, en general, a formulaciones de polvo seco de anticuerpos específicos de la linfopoyetina del estroma tímico (TSLP), así como a métodos de tratamiento del asma, usando las formulaciones de polvo seco, convenientemente, por vía pulmonar. Reivindicación 1: Una formulación de polvo seco que comprende una pluralidad de micropartículas, comprendiendo las micropartículas: a. leucina; b. de aproximadamente el 1% a aproximadamente el 10% en peso de trileucina; y c. un fragmento de unión a antígeno de un anticuerpo anti-linfopoyetina del estroma tímico (TSLP) que comprende: un dominio variable de cadena pesada que comprende: i. una secuencia de CDR1 de cadena pesada que comprende la secuencia de aminoácidos establecida en SEQ ID Nº 1; ii. una secuencia de CDR2 de cadena pesada que comprende la secuencia de aminoácidos establecida en SEQ ID Nº 2; y iii. una secuencia de CDR3 de cadena pesada que comprende la secuencia de aminoácidos establecida en SEQ ID Nº 3, en donde cualquiera de las CDR1, 2 ó 3 de cadena pesada comprende opcionalmente una sustitución de un solo aminoácido; y un dominio variable de cadena ligera que comprende: i. una secuencia de CDR1 de cadena ligera que comprende la secuencia de aminoácidos establecida en SEQ ID Nº 5; ii. una secuencia de CDR2 de cadena ligera que comprende la secuencia de aminoácidos establecida en SEQ ID Nº 6, y iii. una secuencia de CDR3 de cadena ligera que comprende la secuencia de aminoácidos establecida en SEQ ID Nº 7; en donde cualquiera de las CDR1, 2 ó 3 de cadena ligera comprende opcionalmente una sustitución de un solo aminoácido, en donde la leucina y la trileucina están presentes en una proporción de concentraciones de leucina: trileucina de aproximadamente 0.1:1 a aproximadamente 30.
ARP200102963A 2019-10-28 2020-10-27 Formulaciones de polvo seco de anticuerpos que se unen a la linfopoyetina del estroma tímico (tslp) y métodos de uso de las mismas AR120309A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201962926833P 2019-10-28 2019-10-28

Publications (1)

Publication Number Publication Date
AR120309A1 true AR120309A1 (es) 2022-02-09

Family

ID=73030137

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP200102963A AR120309A1 (es) 2019-10-28 2020-10-27 Formulaciones de polvo seco de anticuerpos que se unen a la linfopoyetina del estroma tímico (tslp) y métodos de uso de las mismas

Country Status (15)

Country Link
US (2) US11904053B2 (es)
EP (1) EP4051708A1 (es)
JP (1) JP2022554249A (es)
KR (1) KR20220088752A (es)
CN (1) CN114867748A (es)
AR (1) AR120309A1 (es)
AU (1) AU2020376222A1 (es)
BR (1) BR112022008031A2 (es)
CA (1) CA3154999A1 (es)
CO (1) CO2022005391A2 (es)
CR (1) CR20220189A (es)
IL (1) IL292437A (es)
MX (1) MX2022005083A (es)
TW (1) TW202131947A (es)
WO (1) WO2021083908A1 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202306982A (zh) * 2021-04-19 2023-02-16 英商梅迪繆思有限公司 具有改善的穩定性的抗tslp fab
WO2023064770A1 (en) * 2021-10-11 2023-04-20 Board Of Regents, The University Of Texas System Dry formulations of anti-sars-cov-2 virus antibodies and compositions and methods of use thereof

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU775565B2 (en) * 1999-10-29 2004-08-05 Novartis Ag Dry powder compositions having improved dispersivity
US7982016B2 (en) 2007-09-10 2011-07-19 Amgen Inc. Antigen binding proteins capable of binding thymic stromal lymphopoietin
BR112017019412A2 (pt) * 2015-03-11 2018-05-02 Glaxosmithkline Ip Dev Ltd proteínas ligadoras de tslp
US10000561B2 (en) * 2015-09-09 2018-06-19 Novartis Ag Thymic stromal lymphopoietin (TSLP)-binding molecules and methods of using the molecules
AU2016320743B2 (en) * 2015-09-09 2019-07-04 Novartis Ag Targeted delivery of spray-dried formulations to the lungs
LT3347377T (lt) * 2015-09-09 2021-05-25 Novartis Ag Užkrūčio liaukos stromos limfopoetiną (tslp) rišantys antikūnai ir antikūnų panaudojimo būdai
JOP20190243A1 (ar) * 2017-04-12 2019-10-13 Medimmune Llc علاج الربو بجسم مضاد لـ tslp
JP2021510723A (ja) 2018-01-26 2021-04-30 ノバルティス アーゲー 吸入型治療薬の高用量送達

Also Published As

Publication number Publication date
EP4051708A1 (en) 2022-09-07
MX2022005083A (es) 2022-07-19
TW202131947A (zh) 2021-09-01
CN114867748A (zh) 2022-08-05
WO2021083908A1 (en) 2021-05-06
KR20220088752A (ko) 2022-06-28
JP2022554249A (ja) 2022-12-28
BR112022008031A2 (pt) 2022-07-12
US20230201120A1 (en) 2023-06-29
CO2022005391A2 (es) 2022-08-19
US11904053B2 (en) 2024-02-20
IL292437A (en) 2022-06-01
CA3154999A1 (en) 2021-05-06
US20210121406A1 (en) 2021-04-29
AU2020376222A1 (en) 2022-06-02
CR20220189A (es) 2022-08-19

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