PE20200153A1 - Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t - Google Patents

Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t

Info

Publication number
PE20200153A1
PE20200153A1 PE2019001535A PE2019001535A PE20200153A1 PE 20200153 A1 PE20200153 A1 PE 20200153A1 PE 2019001535 A PE2019001535 A PE 2019001535A PE 2019001535 A PE2019001535 A PE 2019001535A PE 20200153 A1 PE20200153 A1 PE 20200153A1
Authority
PE
Peru
Prior art keywords
pharmaceutical composition
lymphocytes
antibodies
activate
low
Prior art date
Application number
PE2019001535A
Other languages
English (en)
Inventor
Sekhar Kanapuram
Pavan Ghattyvenkatakrishna
Cornelius Pompe
Arnold Mcauley
Jeff Abel
Joon Huh
Michael Treuheit
Bharadwaj Jagannathan
Original Assignee
Amgen Inc
Amgen Res Munich Gmbh
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 Amgen Inc, Amgen Res Munich Gmbh filed Critical Amgen Inc
Publication of PE20200153A1 publication Critical patent/PE20200153A1/es

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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
    • A61K47/26Carbohydrates, 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], 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 [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • A61K2039/545Medicinal 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
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/524CH2 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/526CH3 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/53Hinge
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622Single chain antibody (scFv)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La presente invencion proporciona una composicion farmaceutica liquida que comprende: (a) una construccion de anticuerpos que comprende un primer dominio que se une a un antigeno de superficie celular diana, un segundo dominio que se une a un segundo antigeno y un tercer dominio que comprende dos monomeros polipeptidicos; (b) al menos un agente amortiguador; (c) al menos un sacarido; y (d) al menos un tensioactivo; y en donde el pH de la composicion farmaceutica esta en el intervalo de 3.5 a 6
PE2019001535A 2017-02-02 2018-02-02 Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t PE20200153A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762453952P 2017-02-02 2017-02-02
PCT/EP2018/052665 WO2018141910A1 (en) 2017-02-02 2018-02-02 Low ph pharmaceutical composition comprising t cell engaging antibody constructs

Publications (1)

Publication Number Publication Date
PE20200153A1 true PE20200153A1 (es) 2020-01-17

Family

ID=61274222

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2019001535A PE20200153A1 (es) 2017-02-02 2018-02-02 Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t

Country Status (26)

Country Link
US (1) US20200332000A1 (es)
EP (1) EP3576788A1 (es)
JP (3) JP7189141B2 (es)
KR (2) KR102658637B1 (es)
CN (1) CN110582297B (es)
AR (1) AR110955A1 (es)
AU (1) AU2018214223A1 (es)
BR (1) BR112019016104A2 (es)
CA (1) CA3052098A1 (es)
CL (1) CL2019002178A1 (es)
CO (1) CO2019009480A2 (es)
CR (1) CR20190408A (es)
EA (1) EA201991769A1 (es)
IL (1) IL268351A (es)
JO (1) JOP20190189A1 (es)
MA (1) MA47425A (es)
MX (2) MX2019009133A (es)
NZ (1) NZ756016A (es)
PE (1) PE20200153A1 (es)
PH (1) PH12019501796A1 (es)
SA (1) SA519402365B1 (es)
SG (1) SG11201907048UA (es)
TN (1) TN2019000225A1 (es)
TW (1) TWI840325B (es)
WO (1) WO2018141910A1 (es)
ZA (1) ZA201905674B (es)

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EA039859B1 (ru) * 2016-02-03 2022-03-21 Эмджен Рисерч (Мюник) Гмбх Биспецифические конструкты антител, связывающие egfrviii и cd3
AR117628A1 (es) * 2018-07-31 2021-08-18 Amgen Inc Formulaciones y composiciones farmacéuticas que comprenden una proteína de unión a antígeno enmascarada
AU2019356564A1 (en) * 2018-10-11 2021-04-29 Amgen Inc. Downstream processing of bispecific antibody constructs
EP4054590A1 (en) 2019-11-04 2022-09-14 Amgen Inc. Methods for treating leukemia
US20230167176A1 (en) 2020-04-29 2023-06-01 Amgen Inc. Pharmaceutical formulation
WO2021222355A1 (en) 2020-04-29 2021-11-04 Amgen Inc. Pharmaceutical formulation
US20230203198A1 (en) * 2020-06-04 2023-06-29 Amgen Inc. Bispecific binding constructs
CA3185960A1 (en) * 2020-08-24 2022-03-03 Bharadwaj JAGANNATHAN Pharmaceutical formulation comprising a bite, bispecific antibody, and methionine
WO2022060878A1 (en) 2020-09-16 2022-03-24 Amgen Inc. Methods for treating prostate cancer
JP2023542257A (ja) 2020-09-16 2023-10-05 アムジェン インコーポレイテッド 癌の治療のために二重特異性t細胞誘導分子の治療用量を投与する方法
EP4247850A1 (en) 2020-11-20 2023-09-27 Simcere Innovation, Inc. Armed dual car-t compositions and methods for cancer immunotherapy
AU2023238724A1 (en) 2022-03-21 2024-09-05 Amgen Inc. Combination therapy methods with t-cell engaging molecules for treatment of prostate cancer
WO2024077044A1 (en) 2022-10-05 2024-04-11 Amgen Inc. Combination therapies comprising t-cell redirecting therapies and agonistic anti-il-2r antibodies or fragments thereof

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