MX2024005727A - Formulaciones estables que comprenden un anticuerpo biespecifico para bcma/cd3. - Google Patents

Formulaciones estables que comprenden un anticuerpo biespecifico para bcma/cd3.

Info

Publication number
MX2024005727A
MX2024005727A MX2024005727A MX2024005727A MX2024005727A MX 2024005727 A MX2024005727 A MX 2024005727A MX 2024005727 A MX2024005727 A MX 2024005727A MX 2024005727 A MX2024005727 A MX 2024005727A MX 2024005727 A MX2024005727 A MX 2024005727A
Authority
MX
Mexico
Prior art keywords
antibody
stable formulations
aqueous pharmaceutical
stable aqueous
bcma
Prior art date
Application number
MX2024005727A
Other languages
English (en)
Spanish (es)
Inventor
Salman Muzammil
Matthew Joseph Mistilis
Shyamal Choudhari
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 MX2024005727A publication Critical patent/MX2024005727A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2809Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878Immunoglobulins [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
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins 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)
MX2024005727A 2021-11-10 2022-11-09 Formulaciones estables que comprenden un anticuerpo biespecifico para bcma/cd3. MX2024005727A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163277885P 2021-11-10 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
MX2024005727A true MX2024005727A (es) 2024-05-27

Family

ID=86336796

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2024005727A MX2024005727A (es) 2021-11-10 2022-11-09 Formulaciones estables que comprenden un anticuerpo biespecifico para bcma/cd3.

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
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
CA3238152A1 (en) 2023-05-19
EP4430082A1 (en) 2024-09-18
US20230279136A1 (en) 2023-09-07

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