CO2019009480A2 - Composición farmacéutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t - Google Patents

Composición farmacéutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t

Info

Publication number
CO2019009480A2
CO2019009480A2 CONC2019/0009480A CO2019009480A CO2019009480A2 CO 2019009480 A2 CO2019009480 A2 CO 2019009480A2 CO 2019009480 A CO2019009480 A CO 2019009480A CO 2019009480 A2 CO2019009480 A2 CO 2019009480A2
Authority
CO
Colombia
Prior art keywords
pharmaceutical composition
low
antibody constructs
lymphocytes
activate
Prior art date
Application number
CONC2019/0009480A
Other languages
English (en)
Inventor
Cornelius Pompe
Arnold Mcauley
Pavan Ghattyvenkatakrishna
Jeff Abel
Joon Huh
Sekhar Kanapuram
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 CO2019009480A2 publication Critical patent/CO2019009480A2/es

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    • 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
    • A61K47/26—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [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
    • C07K16/2809—Immunoglobulins [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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • 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
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single 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)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (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 invención proporciona una composición farmacéutica de bajo pH que comprende (a) construcciones de anticuerpos que comprenden un primer dominio que se une a un antígeno de superficie celular diana, un segundo dominio que se une a un segundo antígeno y preferentemente un tercer dominio, que es una modalidad de Fc específica, (b) al menos un agente amortiguador, (c) al menos un sacárido, y (d) al menos un tensioactivo; y en donde el pH de la composición farmacéutica está en el intervalo de 3.5 a 6.
CONC2019/0009480A 2017-02-02 2019-08-30 Composición farmacéutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t CO2019009480A2 (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
CO2019009480A2 true CO2019009480A2 (es) 2019-09-18

Family

ID=61274222

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2019/0009480A CO2019009480A2 (es) 2017-02-02 2019-08-30 Composición farmacéutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t

Country Status (24)

Country Link
US (1) US20200332000A1 (es)
EP (1) EP3576788A1 (es)
JP (2) JP7189141B2 (es)
KR (2) KR102658637B1 (es)
CN (1) CN110582297A (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 (1) MX2019009133A (es)
NZ (1) NZ756016A (es)
PE (1) PE20200153A1 (es)
PH (1) PH12019501796A1 (es)
SG (1) SG11201907048UA (es)
TN (1) TN2019000225A1 (es)
WO (1) WO2018141910A1 (es)
ZA (1) ZA201905674B (es)

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JP7412409B2 (ja) * 2018-07-31 2024-01-12 アムジェン インコーポレイテッド マスクされた抗体の医薬製剤
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
CN115461080A (zh) 2020-04-29 2022-12-09 安进公司 药物配制品
JP2023524444A (ja) 2020-04-29 2023-06-12 アムジェン インコーポレイテッド 医薬製剤
CA3184351A1 (en) * 2020-06-04 2021-12-09 Amgen Inc. Bispecific binding constructs
WO2022046651A1 (en) * 2020-08-24 2022-03-03 Amgen Inc. Pharmaceutical formulation comprising a bite, bispecific antibody, and methionine
AU2021345124A1 (en) 2020-09-16 2023-03-30 Amgen Inc. Methods for administering therapeutic doses of bispecific T-cell engaging molecules for the treatment of cancer
WO2022060878A1 (en) 2020-09-16 2022-03-24 Amgen Inc. Methods for treating prostate cancer
EP4247850A1 (en) 2020-11-20 2023-09-27 Simcere Innovation, Inc. Armed dual car-t compositions and methods for cancer immunotherapy
WO2023183231A1 (en) 2022-03-21 2023-09-28 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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