AU2021286202A1 - Improving antibody tolerability associated with intravenous administration - Google Patents

Improving antibody tolerability associated with intravenous administration Download PDF

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Publication number
AU2021286202A1
AU2021286202A1 AU2021286202A AU2021286202A AU2021286202A1 AU 2021286202 A1 AU2021286202 A1 AU 2021286202A1 AU 2021286202 A AU2021286202 A AU 2021286202A AU 2021286202 A AU2021286202 A AU 2021286202A AU 2021286202 A1 AU2021286202 A1 AU 2021286202A1
Authority
AU
Australia
Prior art keywords
dose
antibody molecule
antibody
administration
therapeutic
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
AU2021286202A
Other languages
English (en)
Inventor
Björn FRENDÉUS
Ingrid KARLSSON
Linda MÅRTENSSON
Ingrid Teige
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.)
Bioinvent International AB
Original Assignee
Bioinvent International AB
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
Priority claimed from EP20178287.7A external-priority patent/EP3919077A1/en
Application filed by Bioinvent International AB filed Critical Bioinvent International AB
Publication of AU2021286202A1 publication Critical patent/AU2021286202A1/en
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/341—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K49/00—Preparations for testing in vivo
    • A61K49/0004—Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
    • A61K49/0008—Screening agents using (non-human) animal models or transgenic animal models or chimeric hosts, e.g. Alzheimer disease animal model, transgenic model for heart failure
    • 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
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/72—Receptors; Cell surface antigens; Cell surface determinants for hormones
    • C07K14/721—Steroid/thyroid hormone superfamily, e.g. GR, EcR, androgen receptor, oestrogen receptor
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Toxicology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Pathology (AREA)
  • Rheumatology (AREA)
  • Urology & Nephrology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
AU2021286202A 2020-06-04 2021-06-04 Improving antibody tolerability associated with intravenous administration Pending AU2021286202A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP20178287.7 2020-06-04
EP20178287.7A EP3919077A1 (en) 2020-06-04 2020-06-04 Model for prediction of tolerability issues in connection with intravenous administration of therapeutic antibodies
EP21163703 2021-03-19
EP21163703.8 2021-03-19
PCT/EP2021/065014 WO2021245238A1 (en) 2020-06-04 2021-06-04 Improving antibody tolerability associated with intravenous administration

Publications (1)

Publication Number Publication Date
AU2021286202A1 true AU2021286202A1 (en) 2023-01-19

Family

ID=76217874

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021286202A Pending AU2021286202A1 (en) 2020-06-04 2021-06-04 Improving antibody tolerability associated with intravenous administration

Country Status (12)

Country Link
US (2) US20230322933A1 (cg-RX-API-DMAC10.html)
EP (2) EP4161574A1 (cg-RX-API-DMAC10.html)
JP (1) JP2023527926A (cg-RX-API-DMAC10.html)
KR (1) KR20230038180A (cg-RX-API-DMAC10.html)
CN (1) CN116322767A (cg-RX-API-DMAC10.html)
AU (1) AU2021286202A1 (cg-RX-API-DMAC10.html)
BR (1) BR112022024745A2 (cg-RX-API-DMAC10.html)
CA (1) CA3185020A1 (cg-RX-API-DMAC10.html)
IL (1) IL298757A (cg-RX-API-DMAC10.html)
MX (1) MX2022015229A (cg-RX-API-DMAC10.html)
TW (3) TW202210102A (cg-RX-API-DMAC10.html)
WO (3) WO2021245233A1 (cg-RX-API-DMAC10.html)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202342057A (zh) * 2022-02-07 2023-11-01 美商健生生物科技公司 用於減少用ｅｇｆｒ／ｍｅｔ雙特異性抗體治療之患者的輸注相關反應之方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ243706A (en) 1991-07-25 1994-08-26 Idec Pharma Corp Recombinant monkey antibodies, pharmaceutical compositions
US8187593B2 (en) * 2002-08-14 2012-05-29 Macrogenics, Inc. FcγRIIB specific antibodies and methods of use thereof
MX2012004406A (es) * 2009-10-21 2012-05-08 Immunogen Inc Nuevo regimen de dosificacion y metodo de tratamiento.
GB201013989D0 (en) 2010-08-20 2010-10-06 Univ Southampton Biological materials and methods of using the same
GB2526139A (en) 2014-05-15 2015-11-18 Biolnvent Internat Ab Medicaments, uses and methods
CN108602889A (zh) * 2015-12-22 2018-09-28 瑞泽恩制药公司 医治急性成淋巴细胞性白血病的双特异性抗cd20/抗cd3抗体
WO2019081983A1 (en) * 2017-10-25 2019-05-02 Novartis Ag CD32B TARGETING ANTIBODIES AND METHODS OF USE
JP7800852B2 (ja) 2018-01-10 2026-01-16 バイオインヴェント インターナショナル アーベー 抗体の新規組み合わせおよびその使用
EA202190102A1 (ru) 2018-08-16 2021-07-29 Генмаб А/С Коньюгаты антител к тканевым факторам с лекарственным средством и их применение в лечении рака
ES3009025T3 (en) 2018-08-31 2025-03-25 Regeneron Pharma Dosing strategy that mitigates cytokine release syndrome for cd3/cd20 bispecific antibodies

Also Published As

Publication number Publication date
JP2023527926A (ja) 2023-06-30
IL298757A (en) 2023-02-01
EP4161573A1 (en) 2023-04-12
BR112022024745A2 (pt) 2023-03-07
KR20230038180A (ko) 2023-03-17
TW202210104A (zh) 2022-03-16
CA3185020A1 (en) 2021-12-09
WO2021245238A9 (en) 2023-02-02
CN116322767A (zh) 2023-06-23
TW202210102A (zh) 2022-03-16
WO2021245238A1 (en) 2021-12-09
TW202210103A (zh) 2022-03-16
EP4161574A1 (en) 2023-04-12
WO2021245237A1 (en) 2021-12-09
US20240301070A1 (en) 2024-09-12
MX2022015229A (es) 2023-02-09
WO2021245233A1 (en) 2021-12-09
US20230322933A1 (en) 2023-10-12

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