CA3134538A1 - Formulations of protein molecules comprising iduronate 2-sulfatase - Google Patents

Formulations of protein molecules comprising iduronate 2-sulfatase Download PDF

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Publication number
CA3134538A1
CA3134538A1 CA3134538A CA3134538A CA3134538A1 CA 3134538 A1 CA3134538 A1 CA 3134538A1 CA 3134538 A CA3134538 A CA 3134538A CA 3134538 A CA3134538 A CA 3134538A CA 3134538 A1 CA3134538 A1 CA 3134538A1
Authority
CA
Canada
Prior art keywords
pharmaceutical composition
polypeptide
seq
amino acid
sequence
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CA3134538A
Other languages
English (en)
French (fr)
Inventor
Dana Andersen
Adam CATHERMAN
Tina GIESE
Gunasekaran Kannan
Mihalis Kariolis
Cathal Mahon
Ankit Patel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Denali Therapeutics Inc
Original Assignee
Denali Therapeutics 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 Denali Therapeutics Inc filed Critical Denali Therapeutics Inc
Publication of CA3134538A1 publication Critical patent/CA3134538A1/en
Pending legal-status Critical Current

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Classifications

    • 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
    • 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
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • 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
    • A61K47/20—Organic 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
    • 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
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/06—Sulfuric ester hydrolases (3.1.6)
    • C12Y301/06013—Iduronate-2-sulfatase (3.1.6.13)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/02—Fusion polypeptide containing a localisation/targetting motif containing a signal sequence
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/20—Fusion polypeptide containing a tag with affinity for a non-protein ligand
    • C07K2319/21—Fusion polypeptide containing a tag with affinity for a non-protein ligand containing a His-tag
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • General Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CA3134538A 2019-04-03 2020-04-03 Formulations of protein molecules comprising iduronate 2-sulfatase Pending CA3134538A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962828859P 2019-04-03 2019-04-03
US62/828,859 2019-04-03
US201962832032P 2019-04-10 2019-04-10
US62/832,032 2019-04-10
PCT/US2020/026669 WO2020206320A1 (en) 2019-04-03 2020-04-03 Formulations of protein molecules comprising iduronate 2-sulfatase

Publications (1)

Publication Number Publication Date
CA3134538A1 true CA3134538A1 (en) 2020-10-08

Family

ID=70457135

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3134538A Pending CA3134538A1 (en) 2019-04-03 2020-04-03 Formulations of protein molecules comprising iduronate 2-sulfatase

Country Status (11)

Country Link
US (1) US12667606B2 (cg-RX-API-DMAC10.html)
EP (1) EP3947661A1 (cg-RX-API-DMAC10.html)
JP (2) JP7715635B2 (cg-RX-API-DMAC10.html)
KR (1) KR20220004651A (cg-RX-API-DMAC10.html)
CN (1) CN113785054A (cg-RX-API-DMAC10.html)
AU (1) AU2020252554B2 (cg-RX-API-DMAC10.html)
BR (1) BR112021019520A2 (cg-RX-API-DMAC10.html)
CA (1) CA3134538A1 (cg-RX-API-DMAC10.html)
MA (1) MA71657A (cg-RX-API-DMAC10.html)
MX (1) MX2021011612A (cg-RX-API-DMAC10.html)
WO (1) WO2020206320A1 (cg-RX-API-DMAC10.html)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS63818B1 (sr) 2017-02-17 2023-01-31 Denali Therapeutics Inc Konstruisani polipeptidi za vezivanje za receptor transferina
BR112020005271A2 (pt) 2017-10-02 2020-09-15 Denali Therapeutics Inc. proteína, polipeptídeo, polinucleotídeo, vetor, célula hospedeira, método para produção de um polipeptídeo, métodos de tratamento de um distúrbio, de diminuição do acúmulo, de monitoramento, de transporte de um agente e de tratamento de um lsd e composição farmacêutica
RS67656B1 (sr) 2018-05-10 2026-02-27 Regeneron Pharma Formulacije koje sadrže visoke koncentracije fuzionog proteina vegf receptora
EP3699923A1 (de) * 2019-02-20 2020-08-26 Fresenius Medical Care Deutschland GmbH Absicherungsmechanismus fuer den betrieb von medizinischen geraeten unter verwendung von verbrauchsgegenstaenden im umfeld einer dialyse
JP7543290B2 (ja) 2019-02-20 2024-09-02 デナリ セラピューティクス インコーポレイテッド 抗ｔｒｅｍ２抗体及びその使用方法
BR112022012230A2 (pt) 2019-12-23 2022-08-30 Denali Therapeutics Inc Variantes de progranulina
US11124567B2 (en) 2020-01-13 2021-09-21 Denali Therapeutics Inc. Anti-TREM2 antibodies and methods of use thereof
CR20230178A (es) 2020-10-14 2023-07-26 Denali Therapeutics Inc Proteínas de fusión que comprenden enzimas sulfoglucosamina sulfohidrolasa y métodos de estas
US20250018015A1 (en) 2021-07-23 2025-01-16 Denali Therapeutics Inc. Methods for the treatment of hunter syndrome
IL311003A (en) 2021-08-25 2024-04-01 Denali Therapeutics Inc Anti-2HER antibodies and methods of using them
KR20230134822A (ko) * 2022-03-15 2023-09-22 주식회사 녹십자 α-갈락토시다제 A의 융합단백질을 포함하는 액상 제제
TW202542190A (zh) * 2023-12-20 2025-11-01 美商戴納立製藥公司 包含酸性α—葡萄糖苷酶之融合蛋白及其方法

Family Cites Families (15)

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JP2013507131A (ja) 2009-10-09 2013-03-04 アーメイゲン・テクノロジーズ・インコーポレイテッド Ｃｎｓにおけるイズロン酸２−スルファターゼ活性を増加させるための方法および組成物
WO2015009052A1 (ko) * 2013-07-16 2015-01-22 일동제약 주식회사 하이브리드 면역글로불린 fc와 효소의 융합단백질
EP3556399A1 (en) 2016-12-19 2019-10-23 Hanmi Pharm. Co., Ltd. Brain targeting long-acting protein conjugate
MX2019007824A (es) 2016-12-28 2019-09-09 Japan Chem Res Preparacion liofilizada.
RS63818B1 (sr) 2017-02-17 2023-01-31 Denali Therapeutics Inc Konstruisani polipeptidi za vezivanje za receptor transferina
KR20190013615A (ko) * 2017-07-28 2019-02-11 한미약품 주식회사 이두로네이트 2-설파타제 결합체
WO2019032955A1 (en) 2017-08-10 2019-02-14 Denali Therapeutics Inc. MODIFIED TRANSFERRIN RECEPTOR BINDING POLYPEPTIDES
BR112020005271A2 (pt) 2017-10-02 2020-09-15 Denali Therapeutics Inc. proteína, polipeptídeo, polinucleotídeo, vetor, célula hospedeira, método para produção de um polipeptídeo, métodos de tratamento de um distúrbio, de diminuição do acúmulo, de monitoramento, de transporte de um agente e de tratamento de um lsd e composição farmacêutica
WO2019246071A1 (en) 2018-06-18 2019-12-26 Denali Therapeutics Inc. Fusion proteins comprising progranulin
EP3894864A2 (en) 2018-12-10 2021-10-20 Denali Therapeutics Inc. Lysosomal storage disorder biomarkers and methods of use thereof
WO2021158986A1 (en) 2020-02-07 2021-08-12 Denali Therapeutics Inc. Methods for the treatment of hunter syndrome
CR20230178A (es) 2020-10-14 2023-07-26 Denali Therapeutics Inc Proteínas de fusión que comprenden enzimas sulfoglucosamina sulfohidrolasa y métodos de estas
US20250018015A1 (en) 2021-07-23 2025-01-16 Denali Therapeutics Inc. Methods for the treatment of hunter syndrome
AR128003A1 (es) 2021-12-17 2024-03-20 Denali Therapeutics Inc PROTEÍNAS DE FUSIÓN QUE COMPRENDEN ENZIMAS DE a-L-IDURONIDASA Y MÉTODOS PARA LAS MISMAS
TW202542190A (zh) 2023-12-20 2025-11-01 美商戴納立製藥公司 包含酸性α—葡萄糖苷酶之融合蛋白及其方法

Also Published As

Publication number Publication date
US20220184186A1 (en) 2022-06-16
KR20220004651A (ko) 2022-01-11
WO2020206320A1 (en) 2020-10-08
MX2021011612A (es) 2021-12-10
EP3947661A1 (en) 2022-02-09
BR112021019520A2 (pt) 2021-12-07
AU2020252554A1 (en) 2021-10-28
US12667606B2 (en) 2026-06-30
JP7715635B2 (ja) 2025-07-30
JP2022526799A (ja) 2022-05-26
JP2025148550A (ja) 2025-10-07
AU2020252554B2 (en) 2026-05-28
CN113785054A (zh) 2021-12-10
MA71657A (fr) 2025-05-30

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