AU2021267276B2 - APRIL and BAFF inhibitory immunomodulatory proteins and methods of use thereof - Google Patents

APRIL and BAFF inhibitory immunomodulatory proteins and methods of use thereof Download PDF

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Publication number
AU2021267276B2
AU2021267276B2 AU2021267276A AU2021267276A AU2021267276B2 AU 2021267276 B2 AU2021267276 B2 AU 2021267276B2 AU 2021267276 A AU2021267276 A AU 2021267276A AU 2021267276 A AU2021267276 A AU 2021267276A AU 2021267276 B2 AU2021267276 B2 AU 2021267276B2
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Prior art keywords
taci
amino acid
seq
variant
polypeptide
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AU2021267276A1 (en
Inventor
Daniel William DEMONTE
Stacey Dillon
Lawrence Evans
Joseph L. Kuijper
Stanford L. PENG
Mark Rixon
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Alpine Immune Sciences Inc
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Alpine Immune Sciences Inc
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    • 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
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1774Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • 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
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/62Medicinal 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 a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/6425Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the peptide or protein in the drug conjugate being a receptor, e.g. CD4, a cell surface antigen, i.e. not a peptide ligand targeting the antigen, or a cell surface determinant, i.e. a part of the surface of a cell
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • 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
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/31Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Cell Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Transplantation (AREA)
  • Urology & Nephrology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2021267276A 2020-05-08 2021-05-07 APRIL and BAFF inhibitory immunomodulatory proteins and methods of use thereof Active AU2021267276B2 (en)

Priority Applications (1)

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AU2025200430A AU2025200430A1 (en) 2020-05-08 2025-01-22 APRIL and BAFF inhibitory immunomodulatory proteins and methods of use thereof

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US202063022373P 2020-05-08 2020-05-08
US63/022,373 2020-05-08
US202063034361P 2020-06-03 2020-06-03
US63/034,361 2020-06-03
US202063080643P 2020-09-18 2020-09-18
US63/080,643 2020-09-18
PCT/US2021/031430 WO2021226551A1 (en) 2020-05-08 2021-05-07 April and baff inhibitory immunomodulatory proteins and methods of use thereof

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AU2025200430A Division AU2025200430A1 (en) 2020-05-08 2025-01-22 APRIL and BAFF inhibitory immunomodulatory proteins and methods of use thereof

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AU2021267276A1 AU2021267276A1 (en) 2022-12-15
AU2021267276B2 true AU2021267276B2 (en) 2024-10-24

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AU2021267276A Active AU2021267276B2 (en) 2020-05-08 2021-05-07 APRIL and BAFF inhibitory immunomodulatory proteins and methods of use thereof
AU2021268033A Pending AU2021268033A1 (en) 2020-05-08 2021-05-07 APRIL and BAFF inhibitory immunomodulatory proteins with and without a T cell inhibitory protein and methods of use thereof
AU2025200430A Pending AU2025200430A1 (en) 2020-05-08 2025-01-22 APRIL and BAFF inhibitory immunomodulatory proteins and methods of use thereof

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AU2025200430A Pending AU2025200430A1 (en) 2020-05-08 2025-01-22 APRIL and BAFF inhibitory immunomodulatory proteins and methods of use thereof

Country Status (15)

Country Link
US (7) US12202882B2 (enExample)
EP (2) EP4146684A2 (enExample)
JP (3) JP7748393B2 (enExample)
KR (2) KR20230029622A (enExample)
CN (5) CN119258195A (enExample)
AU (3) AU2021267276B2 (enExample)
BR (2) BR112022022524A2 (enExample)
CA (2) CA3178882A1 (enExample)
CL (1) CL2022003104A1 (enExample)
CO (1) CO2022017780A2 (enExample)
IL (2) IL297980A (enExample)
MX (2) MX2022013999A (enExample)
PE (1) PE20230494A1 (enExample)
TW (1) TW202208414A (enExample)
WO (2) WO2021226551A1 (enExample)

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CA3077509A1 (en) 2017-10-10 2019-04-18 Alpine Immune Sciences, Inc. Ctla-4 variant immunomodulatory proteins and uses thereof
AU2019205273B2 (en) 2018-01-03 2024-04-04 Alpine Immune Sciences, Inc. Multi-domain immunomodulatory proteins and methods of use thereof
CN113573732A (zh) * 2019-12-24 2021-10-29 荣昌生物制药(烟台)股份有限公司 TACI-Fc融合蛋白及其用途
PE20230494A1 (es) 2020-05-08 2023-03-23 Alpine Immune Sciences Inc Proteinas inmunomoduladoras inhibidoras de april y baff y metodos de uso de las mismas
JP2024514077A (ja) * 2021-03-31 2024-03-28 江▲蘇▼恒瑞医▲薬▼股▲フン▼有限公司 切断したtaciポリペプチド及びその融合タンパク質並びに使用
CA3216795A1 (en) * 2021-05-07 2022-11-10 Alpine Immune Sciences, Inc. Methods of dosing and treatment with a taci-fc fusion immunomodulatory protein
EP4384201A4 (en) * 2021-08-11 2025-07-30 Akso Biopharmaceutical Inc METHODS FOR REDUCING THE PRODUCTION OF IGA, IGM AND/OR IGG IMMUNOGLOBULINS USING SBCMA VARIANTS AND THEIR FC FUSION PROTEINS
JP2024538452A (ja) * 2021-11-17 2024-10-21 オーリニア・ファーマシューティカルズ・インコーポレイテッド B細胞活性化因子(baff)-増殖誘導リガンド(april)二重阻害剤
JP2025501171A (ja) * 2022-06-08 2025-01-17 榮昌生物制薬(烟台)股▲フン▼有限公司 TACI-Fc融合タンパク質を用いた重症筋無力症の治療方法
WO2024044721A1 (en) * 2022-08-25 2024-02-29 University Of Washington Injectable recombinant protein-based hydrogels for therapeutic delivery
AU2023356958A1 (en) * 2022-10-04 2025-04-03 Alpine Immune Sciences, Inc. Mutated taci-fc fusion proteins for use in the treatment of autoantibody-mediated diseases
AU2023391468A1 (en) * 2022-12-05 2025-07-17 Alexion Pharmaceuticals, Inc. Taci-fc fusion proteins for multifunctional inhibition of baff, april, and neonatal fc receptor
TWI882569B (zh) * 2022-12-07 2025-05-01 大陸商榮昌生物製藥(煙臺)股份有限公司 TACI-Fc融合蛋白液體藥物製劑
WO2025007943A1 (zh) * 2023-07-06 2025-01-09 荣昌生物制药(烟台)股份有限公司 用taci-fc融合蛋白治疗anca相关性血管炎的方法
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