AR130402A2 - Formulaciones de anticuerpos anti-pdl1 - Google Patents
Formulaciones de anticuerpos anti-pdl1Info
- Publication number
- AR130402A2 AR130402A2 ARP230102359A ARP230102359A AR130402A2 AR 130402 A2 AR130402 A2 AR 130402A2 AR P230102359 A ARP230102359 A AR P230102359A AR P230102359 A ARP230102359 A AR P230102359A AR 130402 A2 AR130402 A2 AR 130402A2
- Authority
- AR
- Argentina
- Prior art keywords
- formulations
- concentration
- pdl1
- pdl1 antibodies
- aqueous pharmaceutical
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 3
- 238000009472 formulation Methods 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 abstract 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 abstract 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 1
- 229950008882 polysorbate Drugs 0.000 abstract 1
- 229920000136 polysorbate Polymers 0.000 abstract 1
- 235000017281 sodium acetate Nutrition 0.000 abstract 1
- 239000001632 sodium acetate Substances 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
Classifications
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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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
-
- 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
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
- C07K16/2827—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 B7 molecules, e.g. CD80, CD86
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
La invención proporciona formulaciones farmacéuticas acuosas estables que comprenden un anticuerpo anti-PDL1. La invención también proporciona métodos para preparar tales formulaciones y métodos de uso de tales formulaciones. Reivindicación 1: Una formulación farmacéutica acuosa estable, caracterizada porque comprende un anticuerpo monoclonal anti-PDL1 en una concentración de aproximadamente 40 mg/ml a aproximadamente 125 mg/ml, acetato de histidina o acetato de sodio en una concentración de aproximadamente 15 mM a aproximadamente 25 mM, sacarosa en una concentración de aproximadamente 60 mM a aproximadamente 240 mM, polisorbato en una concentración de aproximadamente 0,005% (p/v) a aproximadamente 0,06% (p/v) y un pH de aproximadamente 5,0 a aproximadamente 6,3.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361883953P | 2013-09-27 | 2013-09-27 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR130402A2 true AR130402A2 (es) | 2024-12-04 |
Family
ID=51703416
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP140103581A AR097791A1 (es) | 2013-09-27 | 2014-09-26 | Formulaciones de anticuerpos anti-pdl1 |
| ARP230102359A AR130402A2 (es) | 2013-09-27 | 2023-09-06 | Formulaciones de anticuerpos anti-pdl1 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP140103581A AR097791A1 (es) | 2013-09-27 | 2014-09-26 | Formulaciones de anticuerpos anti-pdl1 |
Country Status (32)
| Country | Link |
|---|---|
| US (5) | US10875922B2 (es) |
| EP (3) | EP3049441B1 (es) |
| JP (3) | JP6942465B2 (es) |
| KR (1) | KR102331663B1 (es) |
| CN (1) | CN105793288B (es) |
| AR (2) | AR097791A1 (es) |
| AU (3) | AU2014324703C1 (es) |
| BR (1) | BR112016006397B1 (es) |
| CA (1) | CA2925310C (es) |
| CL (1) | CL2016000680A1 (es) |
| CR (1) | CR20160141A (es) |
| DK (1) | DK3049441T3 (es) |
| EA (2) | EA033817B1 (es) |
| ES (1) | ES2768614T3 (es) |
| HR (1) | HRP20200102T1 (es) |
| HU (1) | HUE047194T2 (es) |
| IL (3) | IL244712B (es) |
| LT (1) | LT3049441T (es) |
| MA (1) | MA38960A1 (es) |
| MX (3) | MX375378B (es) |
| MY (1) | MY175472A (es) |
| NZ (1) | NZ719036A (es) |
| PE (1) | PE20160541A1 (es) |
| PH (2) | PH12016500566A1 (es) |
| PL (1) | PL3049441T3 (es) |
| PT (1) | PT3049441T (es) |
| RS (1) | RS59880B1 (es) |
| SG (2) | SG10201708542RA (es) |
| SI (1) | SI3049441T1 (es) |
| TW (2) | TWI660738B (es) |
| UA (1) | UA122478C2 (es) |
| WO (1) | WO2015048520A1 (es) |
Families Citing this family (127)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HUE034832T2 (hu) | 2008-12-09 | 2021-12-28 | Hoffmann La Roche | Anti-PD-L1 antitestek és alkalmazásuk T-sejt-funkció fokozására |
| SI2707030T1 (sl) | 2011-05-09 | 2020-10-30 | Mayo Foundation For Medical Education And Research | Zdravljenje raka |
| AU2013327638B2 (en) | 2012-10-01 | 2018-06-14 | Mayo Foundation For Medical Education And Research | Cancer treatments |
| US10570204B2 (en) | 2013-09-26 | 2020-02-25 | The Medical College Of Wisconsin, Inc. | Methods for treating hematologic cancers |
| SI3049441T1 (sl) | 2013-09-27 | 2020-03-31 | F. Hoffmann-La Roche Ag | Formulacije protiteles proti PD-L1 |
| TWI680138B (zh) | 2014-01-23 | 2019-12-21 | 美商再生元醫藥公司 | 抗ｐｄ-ｌ１之人類抗體 |
| TWI681969B (zh) | 2014-01-23 | 2020-01-11 | 美商再生元醫藥公司 | 針對ｐｄ-１的人類抗體 |
| JOP20200094A1 (ar) | 2014-01-24 | 2017-06-16 | Dana Farber Cancer Inst Inc | جزيئات جسم مضاد لـ pd-1 واستخداماتها |
| JOP20200096A1 (ar) | 2014-01-31 | 2017-06-16 | Children’S Medical Center Corp | جزيئات جسم مضاد لـ tim-3 واستخداماتها |
| WO2015138920A1 (en) | 2014-03-14 | 2015-09-17 | Novartis Ag | Antibody molecules to lag-3 and uses thereof |
| MX380597B (es) | 2014-06-13 | 2025-03-12 | Mayo Found Medical Education & Res | Composición con complejos de nanopartículas/anticuerpos de paclitaxel unidos a albúmina para usarse al tratar linfoma. |
| EP3834889A1 (en) | 2014-06-16 | 2021-06-16 | Mayo Foundation for Medical Education and Research | Treating myelomas |
| EP3191127A1 (en) | 2014-09-13 | 2017-07-19 | Novartis AG | Combination therapies of egfr inhibitors |
| US9446148B2 (en) | 2014-10-06 | 2016-09-20 | Mayo Foundation For Medical Education And Research | Carrier-antibody compositions and methods of making and using the same |
| PE20171067A1 (es) | 2014-10-14 | 2017-07-24 | Novartis Ag | Moleculas de anticuerpo que se unen a pd-l1 y usos de las mismas |
| IL292449B2 (en) | 2015-03-13 | 2024-02-01 | Cytomx Therapeutics Inc | Nucleic acids encoding antibodies against PDL1 and methods for their preparation |
| CA3176224A1 (en) * | 2015-05-22 | 2016-12-01 | Translational Drug Development Llc | Benzamide and active compound compositions and methods of use |
| EA201890790A1 (ru) | 2015-09-29 | 2018-10-31 | Селджин Корпорейшн | Связывающие pd-1 белки и способы их применения |
| ES2839212T3 (es) | 2015-09-29 | 2021-07-05 | Inst Nat Sante Rech Med | Métodos para determinar el estado metabólico de linfomas B |
| TW201713360A (en) | 2015-10-06 | 2017-04-16 | Mayo Foundation | Methods of treating cancer using compositions of antibodies and carrier proteins |
| US10815304B2 (en) | 2015-11-17 | 2020-10-27 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | PD-L1 antibody, antigen-binding fragment thereof and medical application thereof |
| US11058769B2 (en) | 2015-12-07 | 2021-07-13 | Merck Patent Gmbh | Aqueous pharmaceutical formulation comprising anti-PD-L1 antibody Avelumab |
| WO2017112775A1 (en) | 2015-12-22 | 2017-06-29 | Regeneron Pharmaceuticals, Inc. | Combination of anti-pd-1 antibodies and bispecific anti-cd20/anti-cd3 antibodies to treat cancer |
| WO2017118634A1 (en) | 2016-01-04 | 2017-07-13 | INSERM (Institut National de la Santé et de la Recherche Médicale) | Use of pd-1 and tim-3 as a measure for cd8+ cells in predicting and treating renal cell carcinoma |
| WO2017120501A1 (en) | 2016-01-07 | 2017-07-13 | Mayo Foundation For Medical Education And Research | Methods of treating cancer with interferon |
| WO2017118675A1 (en) | 2016-01-08 | 2017-07-13 | F. Hoffmann-La Roche Ag | Methods of treating cea-positive cancers using pd-1 axis binding antagonists and anti-cea/anti-cd3 bispecific antibodies |
| US11351254B2 (en) | 2016-02-12 | 2022-06-07 | Mayo Foundation For Medical Education And Research | Hematologic cancer treatments |
| TW202248213A (zh) | 2016-03-15 | 2022-12-16 | 日商中外製藥股份有限公司 | 使用pd-1軸結合拮抗劑和抗gpc3抗體治療癌症的方法 |
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2019
- 2019-06-05 JP JP2019104978A patent/JP2019194195A/ja not_active Withdrawn
- 2019-08-20 PH PH12019501931A patent/PH12019501931A1/en unknown
- 2019-10-24 IL IL270165A patent/IL270165B/en unknown
-
2020
- 2020-05-19 AU AU2020203267A patent/AU2020203267B2/en active Active
- 2020-11-23 US US17/101,966 patent/US20210221892A1/en not_active Abandoned
-
2021
- 2021-06-29 JP JP2021107154A patent/JP2021169458A/ja not_active Withdrawn
- 2021-08-09 IL IL285474A patent/IL285474A/en unknown
-
2022
- 2022-09-23 AU AU2022235627A patent/AU2022235627A1/en active Pending
-
2023
- 2023-08-02 US US18/364,312 patent/US20240010732A1/en not_active Abandoned
- 2023-09-06 AR ARP230102359A patent/AR130402A2/es unknown
-
2024
- 2024-09-27 US US18/900,229 patent/US20250145717A1/en active Pending
-
2025
- 2025-01-17 US US19/030,020 patent/US20250388677A1/en active Pending
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