CA3238152A1 - Stable formulations comprising a bispecific bcma/cd3 antibody - Google Patents

Stable formulations comprising a bispecific bcma/cd3 antibody Download PDF

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Publication number
CA3238152A1
CA3238152A1 CA3238152A CA3238152A CA3238152A1 CA 3238152 A1 CA3238152 A1 CA 3238152A1 CA 3238152 A CA3238152 A CA 3238152A CA 3238152 A CA3238152 A CA 3238152A CA 3238152 A1 CA3238152 A1 CA 3238152A1
Authority
CA
Canada
Prior art keywords
pharmaceutical composition
aqueous pharmaceutical
stable aqueous
antibody
seq
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
CA3238152A
Other languages
English (en)
French (fr)
Inventor
Salman MUZAMMIL
Matthew Joseph MISTILIS
Shyamal CHOUDHARI
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.)
Janssen Biotech Inc
Original Assignee
Janssen Biotech 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 Janssen Biotech Inc filed Critical Janssen Biotech Inc
Publication of CA3238152A1 publication Critical patent/CA3238152A1/en
Pending legal-status Critical Current

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Classifications

    • 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
    • C07K16/2878—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 NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/26—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
CA3238152A 2021-11-10 2022-11-09 Stable formulations comprising a bispecific bcma/cd3 antibody Pending CA3238152A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163277885P 2021-11-10 2021-11-10
US63/277,885 2021-11-10
PCT/US2022/079535 WO2023086817A1 (en) 2021-11-10 2022-11-09 Stable formulations comprising a bispecific bcma/cd3 antibody

Publications (1)

Publication Number Publication Date
CA3238152A1 true CA3238152A1 (en) 2023-05-19

Family

ID=86336796

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3238152A Pending CA3238152A1 (en) 2021-11-10 2022-11-09 Stable formulations comprising a bispecific bcma/cd3 antibody

Country Status (11)

Country Link
US (1) US20230279136A1 (https=)
EP (1) EP4430082A4 (https=)
JP (1) JP2024544523A (https=)
KR (1) KR20240099432A (https=)
CN (1) CN118251417A (https=)
AU (1) AU2022383848A1 (https=)
CA (1) CA3238152A1 (https=)
IL (1) IL312700A (https=)
MX (1) MX2024005727A (https=)
TW (1) TW202328209A (https=)
WO (1) WO2023086817A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2024005392A (es) 2021-11-03 2024-08-06 Janssen Biotech Inc Métodos para tratar cánceres y potenciar la eficacia de anticuerpos biespecíficos para bcmaxcd3.
WO2024044548A1 (en) * 2022-08-23 2024-02-29 Janssen Biotech, Inc. Teclistamab for the treatment of multiple myeloma
WO2024044545A1 (en) * 2022-08-23 2024-02-29 Janssen Biotech, Inc. Approved products for the treatment of multiple myeloma
WO2024231860A1 (en) * 2023-05-09 2024-11-14 Janssen Biotech, Inc. Pharmaceutical compositions comprising a bispecific bcma/cd3 antibody at high concentration
TW202517293A (zh) * 2023-07-07 2025-05-01 美商再生元醫藥公司 含有抗bcmax抗cd3雙特異性抗體之穩定化配製物
CN121712524A (zh) * 2023-08-18 2026-03-20 百时美施贵宝公司 包含结合bcma和cd3的抗体的组合物以及治疗方法

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2635352C (en) * 1997-06-13 2012-09-11 Genentech, Inc. Stabilized antibody formulation
US20040033228A1 (en) * 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
EP2982692A1 (en) * 2014-08-04 2016-02-10 EngMab AG Bispecific antibodies against CD3epsilon and BCMA
MX2018002043A (es) * 2015-08-17 2018-07-06 Janssen Pharmaceutica Nv ANTICUERPOS ANTI-BCMA, MOLí‰CULAS DE UNIí“N A ANTíGENOS BIESPECíFICAS QUE SE UNEN A BCMA Y CD3, Y USOS DE ESTOS.
UA130542C2 (uk) * 2018-05-16 2026-03-18 Янссен Байотек, Інк. Антитіло до cd38 та терапевтичний засіб, який перенаправляє т-клітини, для лікування множинної мієломи у суб'єкта
US11591395B2 (en) * 2019-04-19 2023-02-28 Janssen Biotech, Inc. Methods of treating prostate cancer with an anti-PSMA/CD3 antibody

Also Published As

Publication number Publication date
IL312700A (en) 2024-07-01
EP4430082A4 (en) 2025-09-03
MX2024005727A (es) 2024-05-27
JP2024544523A (ja) 2024-12-03
CN118251417A (zh) 2024-06-25
AU2022383848A1 (en) 2024-06-27
KR20240099432A (ko) 2024-06-28
TW202328209A (zh) 2023-07-16
WO2023086817A1 (en) 2023-05-19
EP4430082A1 (en) 2024-09-18
US20230279136A1 (en) 2023-09-07

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