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MX2025002707A - 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
MX2025002707A
MX2025002707A MX2025002707A MX2025002707A MX2025002707A MX 2025002707 A MX2025002707 A MX 2025002707A MX 2025002707 A MX2025002707 A MX 2025002707A MX 2025002707 A MX2025002707 A MX 2025002707A MX 2025002707 A MX2025002707 A MX 2025002707A
Authority
MX
Mexico
Prior art keywords
pharmaceutical composition
low
antibody constructs
cell engaging
engaging antibody
Prior art date
Application number
MX2025002707A
Other languages
English (en)
Inventor
Arnold Mcauley
Pavan Ghattyvenkatakrishna
Jeff Abel
Joon Huh
Cornelius Pompe
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 MX2025002707A publication Critical patent/MX2025002707A/es

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    • 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 [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
    • 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
    • C07K16/2863Immunoglobulins [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 growth factors, growth regulators
    • 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
    • C07K16/2887Immunoglobulins [IG], 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)
  • Epidemiology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Virology (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 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.
MX2025002707A 2017-02-02 2019-07-31 Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t MX2025002707A (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
MX2025002707A true MX2025002707A (es) 2025-04-02

Family

ID=61274222

Family Applications (3)

Application Number Title Priority Date Filing Date
MX2019009133A MX2019009133A (es) 2017-02-02 2018-02-02 Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t.
MX2024004337A MX2024004337A (es) 2017-02-02 2019-07-31 Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t.
MX2025002707A MX2025002707A (es) 2017-02-02 2019-07-31 Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t

Family Applications Before (2)

Application Number Title Priority Date Filing Date
MX2019009133A MX2019009133A (es) 2017-02-02 2018-02-02 Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t.
MX2024004337A MX2024004337A (es) 2017-02-02 2019-07-31 Composicion farmaceutica de bajo ph que comprende construcciones de anticuerpos que activan linfocitos t.

Country Status (39)

Country Link
US (2) US20200332000A1 (es)
EP (3) EP3576788B1 (es)
JP (3) JP7189141B2 (es)
KR (3) KR102853228B1 (es)
CN (1) CN110582297B (es)
AR (1) AR110955A1 (es)
AU (3) AU2018214223B2 (es)
BR (1) BR112019016104A2 (es)
CA (1) CA3052098A1 (es)
CL (1) CL2019002178A1 (es)
CO (1) CO2019009480A2 (es)
CR (1) CR20190408A (es)
DK (1) DK3576788T3 (es)
EA (1) EA201991769A1 (es)
ES (1) ES3040289T3 (es)
FI (1) FI3576788T3 (es)
HR (1) HRP20250830T1 (es)
HU (1) HUE072190T2 (es)
IL (3) IL321314A (es)
JO (2) JOP20190189A1 (es)
LT (1) LT3576788T (es)
MA (1) MA47425B1 (es)
MD (1) MD3576788T2 (es)
MX (3) MX2019009133A (es)
MY (1) MY201516A (es)
NZ (1) NZ756016A (es)
PE (1) PE20200153A1 (es)
PH (1) PH12019501796A1 (es)
PL (1) PL3576788T3 (es)
PT (1) PT3576788T (es)
RS (1) RS67174B1 (es)
SA (1) SA519402365B1 (es)
SG (1) SG11201907048UA (es)
SI (1) SI3576788T1 (es)
SM (1) SMT202500367T1 (es)
TN (1) TN2019000225A1 (es)
TW (2) TW202502381A (es)
WO (1) WO2018141910A1 (es)
ZA (1) ZA201905674B (es)

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AU2019356564A1 (en) * 2018-10-11 2021-04-29 Amgen Inc. Downstream processing of bispecific antibody constructs
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