AU2023224098A1 - Dosing regimens for mitigation of cytokine release syndrome with odronextamab - Google Patents

Dosing regimens for mitigation of cytokine release syndrome with odronextamab Download PDF

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Publication number
AU2023224098A1
AU2023224098A1 AU2023224098A AU2023224098A AU2023224098A1 AU 2023224098 A1 AU2023224098 A1 AU 2023224098A1 AU 2023224098 A AU2023224098 A AU 2023224098A AU 2023224098 A AU2023224098 A AU 2023224098A AU 2023224098 A1 AU2023224098 A1 AU 2023224098A1
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AU
Australia
Prior art keywords
dose
dosing regimen
subject
fraction
bispecific antibody
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Pending
Application number
AU2023224098A
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English (en)
Inventor
Srikanth R. AMBATI
Aafia CHAUDHRY
Masood KHAKSAR TOROGHI
Hesham Mohamed
Min Zhu
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Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Publication date
Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of AU2023224098A1 publication Critical patent/AU2023224098A1/en
Pending legal-status Critical Current

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    • 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
    • C07K16/2809—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 the T-cell receptor (TcR)-CD3 complex
    • 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
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional 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
    • A61K2039/505—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
    • A61K2039/545—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
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2023224098A 2022-02-25 2023-02-24 Dosing regimens for mitigation of cytokine release syndrome with odronextamab Pending AU2023224098A1 (en)

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US202263313932P 2022-02-25 2022-02-25
US63/313,932 2022-02-25
US202263393212P 2022-07-28 2022-07-28
US63/393,212 2022-07-28
US202263420782P 2022-10-31 2022-10-31
US63/420,782 2022-10-31
US202263424210P 2022-11-10 2022-11-10
US63/424,210 2022-11-10
US202363440304P 2023-01-20 2023-01-20
US63/440,304 2023-01-20
PCT/US2023/013836 WO2023164143A1 (en) 2022-02-25 2023-02-24 Dosing regimens for mitigation of cytokine release syndrome with odronextamab

Publications (1)

Publication Number Publication Date
AU2023224098A1 true AU2023224098A1 (en) 2024-09-12

Family

ID=85778997

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2023224098A Pending AU2023224098A1 (en) 2022-02-25 2023-02-24 Dosing regimens for mitigation of cytokine release syndrome with odronextamab

Country Status (11)

Country Link
US (1) US20230272118A1 (https=)
EP (1) EP4482524A1 (https=)
JP (1) JP2025508832A (https=)
KR (1) KR20240167457A (https=)
CN (1) CN119156226A (https=)
AU (1) AU2023224098A1 (https=)
CA (1) CA3244791A1 (https=)
IL (1) IL315011A (https=)
MX (1) MX2024010292A (https=)
TW (1) TW202400228A (https=)
WO (1) WO2023164143A1 (https=)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL85035A0 (en) 1987-01-08 1988-06-30 Int Genetic Eng Polynucleotide molecule,a chimeric antibody with specificity for human b cell surface antigen,a process for the preparation and methods utilizing the same
EP1400536A1 (en) 1991-06-14 2004-03-24 Genentech Inc. Method for making humanized antibodies
MY192182A (en) 2009-06-26 2022-08-04 Regeneron Pharma Readily isolated bispecific antibodies with native immunoglobulin format
SMT202600080T1 (it) 2010-02-08 2026-03-09 Regeneron Pharma Topo con catena leggera comune
TWI635098B (zh) 2013-02-01 2018-09-11 再生元醫藥公司 含嵌合恆定區之抗體
CA3110513A1 (en) * 2018-08-31 2020-03-05 Regeneron Pharmaceuticals, Inc. Dosing strategy that mitigates cytokine release syndrome for cd3/c20 bispecific antibodies
TW202135860A (zh) 2019-12-10 2021-10-01 美商再生元醫藥公司 含有抗ｃｄ２０ｘ抗ｃｄ３雙特異性抗體之穩定調配物

Also Published As

Publication number Publication date
IL315011A (en) 2024-10-01
MX2024010292A (es) 2024-12-06
US20230272118A1 (en) 2023-08-31
WO2023164143A1 (en) 2023-08-31
CN119156226A (zh) 2024-12-17
JP2025508832A (ja) 2025-04-10
TW202400228A (zh) 2024-01-01
EP4482524A1 (en) 2025-01-01
KR20240167457A (ko) 2024-11-26
CA3244791A1 (en) 2023-08-31

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