CA3228105A1 - Subcutaneous unit dosage forms - Google Patents

Subcutaneous unit dosage forms Download PDF

Info

Publication number
CA3228105A1
CA3228105A1 CA3228105A CA3228105A CA3228105A1 CA 3228105 A1 CA3228105 A1 CA 3228105A1 CA 3228105 A CA3228105 A CA 3228105A CA 3228105 A CA3228105 A CA 3228105A CA 3228105 A1 CA3228105 A1 CA 3228105A1
Authority
CA
Canada
Prior art keywords
biologic
dose
unit dosage
efgartigimod
region
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
CA3228105A
Other languages
English (en)
French (fr)
Inventor
Antoinetta Jacoba Maria VAN BRAGT
Peter Ulrichts
Erik HOFMAN
Peter Verheesen
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.)
ArgenX BVBA
Original Assignee
ArgenX BVBA
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 ArgenX BVBA filed Critical ArgenX BVBA
Publication of CA3228105A1 publication Critical patent/CA3228105A1/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • 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
    • 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)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/283—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • 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
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
CA3228105A 2021-08-02 2022-08-02 Subcutaneous unit dosage forms Pending CA3228105A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163203856P 2021-08-02 2021-08-02
US63/203,856 2021-08-02
PCT/IB2022/000443 WO2023012515A2 (en) 2021-08-02 2022-08-02 Subcutaneous unit dosage forms

Publications (1)

Publication Number Publication Date
CA3228105A1 true CA3228105A1 (en) 2023-02-09

Family

ID=83192179

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3228105A Pending CA3228105A1 (en) 2021-08-02 2022-08-02 Subcutaneous unit dosage forms

Country Status (11)

Country Link
US (1) US20240325528A1 (https=)
EP (1) EP4380618A2 (https=)
JP (1) JP2024530152A (https=)
KR (1) KR20240040104A (https=)
CN (1) CN117897172A (https=)
AU (1) AU2022322077A1 (https=)
CA (1) CA3228105A1 (https=)
IL (1) IL310608A (https=)
MX (1) MX2024001631A (https=)
TW (1) TW202320849A (https=)
WO (1) WO2023012515A2 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3081144A1 (en) 2017-12-08 2019-06-13 Argenx Bvba Use of fcrn antagonists for treatment of generalized myasthenia gravis
US12202900B2 (en) 2018-06-08 2025-01-21 argenx BV Compositions and methods for treating immune thrombocytopenia
JP2023509195A (ja) 2020-01-08 2023-03-07 アルジェニクス ビーブイ 天疱瘡症を治療する方法
CN119365209A (zh) * 2022-04-26 2025-01-24 阿根思有限公司 用于使用fcrn拮抗剂治疗大疱性类天疱疮的方法
CN119698429A (zh) 2022-06-15 2025-03-25 阿根思有限公司 Fcrn结合分子及使用方法
WO2025233684A1 (en) * 2024-05-10 2025-11-13 argenx BV Subcutaneous formulations, pre-filled syringes and methods of use thereof

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7871607B2 (en) 2003-03-05 2011-01-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases
NZ542873A (en) 2003-03-05 2008-07-31 Halozyme Inc Soluble, neutral-active hyaluronidase activity glycoprotein (sHASEGP) that is produced with high yield in a mammalian expression system by introducing nucleic acids that lack a narrow region encoding amino acids in the carboxy terminus of the human PH20 cDNA
SI4269578T1 (sl) 2008-03-06 2024-07-31 Halozyme, Inc. Sestava topne hialuronidaze
EA022752B1 (ru) 2008-12-09 2016-02-29 Галозим, Инк. Длинные растворимые полипептиды рн20 и их использование
HUE028832T2 (en) * 2009-09-17 2017-01-30 Baxalta Inc Stable co-formulation of hyaluronidase and immunoglobulin, as well as a process for its preparation
WO2013102144A2 (en) 2011-12-30 2013-07-04 Halozyme, Inc. Ph20 polypeptede variants, formulations and uses thereof
CA3081144A1 (en) * 2017-12-08 2019-06-13 Argenx Bvba Use of fcrn antagonists for treatment of generalized myasthenia gravis
MX2020009824A (es) 2018-07-25 2021-01-15 Alteogen Inc Nuevas variantes de hialuronidasa y composicion farmaceutica que comprende la misma.
KR102650991B1 (ko) 2019-03-25 2024-03-27 (주)알테오젠 인간 히알루로니다제 ph20의 변이체와 약물을 포함하는 피하투여용 약학 조성물
JP2023509195A (ja) * 2020-01-08 2023-03-07 アルジェニクス ビーブイ 天疱瘡症を治療する方法

Also Published As

Publication number Publication date
WO2023012515A2 (en) 2023-02-09
IL310608A (en) 2024-04-01
WO2023012515A3 (en) 2023-04-06
CN117897172A (zh) 2024-04-16
KR20240040104A (ko) 2024-03-27
US20240325528A1 (en) 2024-10-03
TW202320849A (zh) 2023-06-01
JP2024530152A (ja) 2024-08-16
AU2022322077A1 (en) 2024-02-08
MX2024001631A (es) 2024-04-19
EP4380618A2 (en) 2024-06-12

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