AR110955A1 - COMPOSICIÓN FARMACÉUTICA DE BAJO pH QUE COMPRENDE CONSTRUCTOS DE ANTICUERPO QUE ACOPLAN CÉLULAS T - Google Patents
COMPOSICIÓN FARMACÉUTICA DE BAJO pH QUE COMPRENDE CONSTRUCTOS DE ANTICUERPO QUE ACOPLAN CÉLULAS TInfo
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- AR110955A1 AR110955A1 ARP180100246A ARP180100246A AR110955A1 AR 110955 A1 AR110955 A1 AR 110955A1 AR P180100246 A ARP180100246 A AR P180100246A AR P180100246 A ARP180100246 A AR P180100246A AR 110955 A1 AR110955 A1 AR 110955A1
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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
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
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- 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
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- 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
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- 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
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- 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
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- 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)
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- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
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- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
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- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
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- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
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- Communicable Diseases (AREA)
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- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Abstract
Una composición farmacéutica con pH bajo que comprende (a) una construcción de anticuerpos que comprende 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 se encuentra en el intervalo de entre 3, 5 y 6. Reivindicación 1: Una composición farmacéutica líquida, caracterizada porque comprende (a) un constructo de anticuerpo que comprende al menos tres dominios, en donde: un primer dominio se une a un antígeno de superficie celular objetivo y tiene un punto isoeléctrico (pI) en el rango de 4 a 9,5; un segundo dominio se une a un segundo antígeno; y tiene un pI en el rango de 8 a 10, preferiblemente 8,5 a 9,5; y un tercer dominio comprende dos monómeros de polipéptidos, cada uno comprende una bisagra, un dominio de CH2 y un dominio de CH3, en donde los dos monómeros de polipéptidos están fusionados entre sí a través de un enlazante de péptido; (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 esta en el rango de 3,5 a 6. Reivindicación 3: La composición farmacéutica líquida de conformidad con cualquiera de las reivindicaciones precedentes, caracterizada porque el tercer dominio comprende en orden de amino a carboxilo: bisagra-dominio de CH2-dominio de CH3-enlazante-bisagra-dominio de CH2-dominio de CH3. Reivindicación 5: La composición farmacéutica líquida de conformidad con cualquiera de las reivindicaciones precedentes, caracterizada porque el antígeno de superficie celular objetivo es un antígeno de tumor, un antígeno específico para un trastorno inmunológico o un antígeno viral. Reivindicación 6: La composición farmacéutica líquida de conformidad con la reivindicación 5, caracterizada porque el antígeno de tumor se selecciona del grupo que consiste de CDH19, MSLN, DLL3, FLT3, EGFR, EGFRvIII, BCMA, PSMA, CD33, CD19, CD20 y CD70. Reivindicación 7: La composición farmacéutica de conformidad con cualquiera de las reivindicaciones precedentes, caracterizada porque el segundo dominio es un epítope extracelular de CD3 en la cadena CD3e humana y/o de Macaca. Reivindicación 9: La composición farmacéutica de conformidad con cualquiera de las reivindicaciones precedentes, caracterizada porque cada uno de los monómeros de polipéptidos del tercer dominio tiene una secuencia de aminoácidos que es idéntica al menos 90% a una secuencia seleccionada del grupo que consiste de SEQ ID Nº 17 - 24, o tiene una secuencia de aminoácidos seleccionada del grupo que consiste de SEQ ID Nº 17 - 24. Reivindicación 12: La composición farmacéutica de conformidad con cualquiera de las reivindicaciones precedentes, caracterizada porque (i) el primer dominio comprende dos dominios variables de anticuerpo y el segundo dominio comprende dos dominios variables de anticuerpo; (ii) el primer dominio comprende un dominio variable de anticuerpo y el segundo dominio comprende dos dominios variables de anticuerpo; (iii) el primer dominio comprende dos dominios variables de anticuerpo y el segundo dominio comprende un dominio variable de anticuerpo; o (iv) el primer dominio comprende un dominio variable de anticuerpo y el segundo dominio comprende un dominio variable de anticuerpo. Reivindicación 13: La composición farmacéutica líquida de conformidad con cualquiera de las reivindicaciones precedentes, caracterizada porque el constructo de anticuerpo comprende preferiblemente en un orden de amino a carboxilo: (a) el primer dominio; (b) un enlazante de péptido que tiene una secuencia de aminoácidos seleccionada del grupo que consiste de SEQ ID Nº 1 - 3; (c) el segundo dominio; (d) un enlazante de péptido que tiene una secuencia de aminoácidos seleccionada del grupo que consiste de SEQ ID Nº 1, 2, 3, 9, 10, 11 y 12; (e) el primer monómero de polipéptido del tercer dominio; (f) un enlazante de péptido que tiene una secuencia de aminoácidos seleccionada del grupo que consiste de SEQ ID Nº 5, 6, 7 y 8; y (g) el segundo monómero de polipéptido del tercer dominio. Reivindicación 18: La composición farmacéutica líquida de conformidad con la reivindicación 16, caracterizada porque el alcohol de azúcar es sorbitol. Reivindicación 26: La composición farmacéutica líquida de conformidad con cualquiera de las reivindicaciones precedentes, caracterizada porque la composición está libre de aniones inorgánicos. Reivindicación 27: La composición farmacéutica liquida de conformidad con cualquiera de las reivindicaciones precedentes, caracterizada porque la composición comprende (a) el constructo de anticuerpo de conformidad con cualquiera de las reivindicaciones precedentes, (b) glutamato o acetato 10 mM, (c) 9% (m/v) de sacarosa o 6% (m/v) de sacarosa y 6% (m/v) de hidroxipropil-b-ciclodextrina, (d) 0,01% (m/v) de polisorbato 80 y en donde el pH de la composición farmacéutica líquida es 4,2.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762453952P | 2017-02-02 | 2017-02-02 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR110955A1 true AR110955A1 (es) | 2019-05-22 |
Family
ID=61274222
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP180100246A AR110955A1 (es) | 2017-02-02 | 2018-02-02 | COMPOSICIÓN FARMACÉUTICA DE BAJO pH QUE COMPRENDE CONSTRUCTOS DE ANTICUERPO QUE ACOPLAN CÉLULAS T |
Country Status (39)
| Country | Link |
|---|---|
| US (2) | US20200332000A1 (es) |
| EP (3) | EP4620975A3 (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 (1) | 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) | TWI840325B (es) |
| WO (1) | WO2018141910A1 (es) |
| ZA (1) | ZA201905674B (es) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EA039859B1 (ru) * | 2015-07-31 | 2022-03-21 | Эмджен Рисерч (Мюник) Гмбх | Биспецифические конструкты антител, связывающие egfrviii и cd3 |
| MA43959A (fr) | 2016-02-03 | 2018-12-12 | Amgen Res Munich Gmbh | Constructions d'anticorps impliquant des cellules t bispécifiques psma et cd3 |
| KR20250004936A (ko) | 2016-12-21 | 2025-01-08 | 테네오바이오, 인코포레이티드 | 항-bcma 중쇄-단독 항체 |
| JOP20190189A1 (ar) * | 2017-02-02 | 2019-08-01 | Amgen Res Munich Gmbh | تركيبة صيدلانية ذات درجة حموضة منخفضة تتضمن بنيات جسم مضاد يستهدف الخلية t |
| MA53333A (fr) * | 2018-07-31 | 2021-11-03 | Amgen Inc | Formulations pharmaceutiques d'anticorps masqués |
| CN112789058A (zh) * | 2018-10-11 | 2021-05-11 | 安进公司 | 双特异性抗体构建体的下游加工 |
| TW202132340A (zh) | 2019-11-04 | 2021-09-01 | 美商安進公司 | 治療白血病之方法 |
| EP4069309A4 (en) * | 2019-12-06 | 2024-03-27 | Theratechnologies Inc. | SORTILIN-BINDING CONJUGATE COMPOUNDS, COMPOSITIONS AND THEIR USE IN THE TREATMENT OF CANCER |
| WO2021222347A1 (en) | 2020-04-29 | 2021-11-04 | Amgen Inc. | Pharmaceutical formulation |
| EP4142790A1 (en) * | 2020-04-29 | 2023-03-08 | Amgen Inc. | Pharmaceutical formulation |
| CA3184351A1 (en) * | 2020-06-04 | 2021-12-09 | Amgen Inc. | Bispecific binding constructs |
| AU2021330845A1 (en) * | 2020-08-24 | 2023-01-19 | Amgen Inc. | Pharmaceutical formulation comprising a bite, bispecific antibody, and methionine |
| WO2022060901A1 (en) | 2020-09-16 | 2022-03-24 | 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 |
| AU2021374839A1 (en) * | 2020-11-06 | 2023-06-08 | Amgen Inc. | Multitargeting bispecific antigen-binding molecules of increased selectivity |
| EP4247850A1 (en) | 2020-11-20 | 2023-09-27 | Simcere Innovation, Inc. | Armed dual car-t compositions and methods for cancer immunotherapy |
| JP2025509892A (ja) | 2022-03-21 | 2025-04-11 | アムジェン インコーポレイテッド | 前立腺癌の治療のためのｔ細胞エンゲージ分子を用いた併用療法 |
| EP4598958A1 (en) | 2022-10-05 | 2025-08-13 | Amgen Inc. | Combination therapies comprising t-cell redirecting therapies and agonistic anti-il-2r antibodies or fragments thereof |
| US20250313641A1 (en) | 2024-04-09 | 2025-10-09 | Amgen Inc. | Agonistic anti-il-2rbg heavy-chain antibodies |
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2022
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