CO2019012143A2 - Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su uso - Google Patents
Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su usoInfo
- Publication number
- CO2019012143A2 CO2019012143A2 CONC2019/0012143A CO2019012143A CO2019012143A2 CO 2019012143 A2 CO2019012143 A2 CO 2019012143A2 CO 2019012143 A CO2019012143 A CO 2019012143A CO 2019012143 A2 CO2019012143 A2 CO 2019012143A2
- Authority
- CO
- Colombia
- Prior art keywords
- methods
- programmed death
- death receptor
- combination
- stable formulations
- Prior art date
Links
Classifications
-
- 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
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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 [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [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
- C07K16/2818—Immunoglobulins [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 CD28 or CD152
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
- A61K2039/507—Comprising a combination of two or more separate antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Dermatology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762500268P | 2017-05-02 | 2017-05-02 | |
| PCT/US2018/030420 WO2018204343A1 (en) | 2017-05-02 | 2018-05-01 | Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO2019012143A2 true CO2019012143A2 (es) | 2020-01-17 |
Family
ID=64016829
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CONC2019/0012143A CO2019012143A2 (es) | 2017-05-02 | 2019-10-30 | Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su uso |
Country Status (17)
| Country | Link |
|---|---|
| US (2) | US20200262922A1 (https=) |
| EP (1) | EP3618866A4 (https=) |
| JP (2) | JP2020518598A (https=) |
| KR (1) | KR102624564B1 (https=) |
| CN (1) | CN110678199B (https=) |
| AU (1) | AU2018263837B2 (https=) |
| BR (1) | BR112019022695A2 (https=) |
| CA (1) | CA3060695A1 (https=) |
| CL (1) | CL2019003143A1 (https=) |
| CO (1) | CO2019012143A2 (https=) |
| EA (1) | EA201992526A1 (https=) |
| MA (1) | MA50501A (https=) |
| MX (1) | MX2019013034A (https=) |
| SG (1) | SG11201910134SA (https=) |
| TN (1) | TN2019000294A1 (https=) |
| UA (1) | UA129862C2 (https=) |
| WO (1) | WO2018204343A1 (https=) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HRP20131167T1 (hr) | 2007-06-18 | 2014-01-03 | Merck Sharp & Dohme B.V. | Antitijela za humani receptor programirane smrti pd-1 |
| HUE033369T2 (en) | 2012-11-20 | 2017-11-28 | Sanofi Sa | Anti-ceacam5 antibodies and uses thereof |
| UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
| WO2018106862A1 (en) | 2016-12-07 | 2018-06-14 | Agenus Inc. | Anti-ctla-4 antibodies and methods of use thereof |
| AU2018263868A1 (en) | 2017-05-02 | 2019-12-12 | Merck Sharp & Dohme Llc | Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies |
| SG11201910134SA (en) * | 2017-05-02 | 2019-11-28 | Merck Sharp & Dohme | Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof |
| JP7402693B2 (ja) * | 2017-05-02 | 2023-12-21 | メルク・シャープ・アンド・ドーム・エルエルシー | 単独のおよびプログラム死受容体１（ｐｄ－１）抗体と組み合わされた抗ｔｉｇｉｔ抗体の安定な製剤、ならびにその使用方法 |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| EP3752193A4 (en) * | 2018-02-13 | 2022-02-23 | Merck Sharp & Dohme Corp. | METHODS OF TREATMENT OF CANCER WITH ANTI-PD-1 ANTIBODIES AND ANTI-CTLA4 ANTIBODIES |
| KR102885113B1 (ko) | 2018-10-18 | 2025-11-13 | 머크 샤프 앤드 돔 엘엘씨 | 항-rsv 항체의 제제 및 그의 사용 방법 |
| CN120842406A (zh) | 2018-10-31 | 2025-10-28 | 默沙东有限责任公司 | 抗人pd-1抗体晶体及其使用方法 |
| CN113316458B (zh) | 2018-11-07 | 2024-08-02 | 默沙东有限责任公司 | 抗lag3抗体和抗pd-1抗体的共制剂 |
| WO2020097141A1 (en) * | 2018-11-07 | 2020-05-14 | Merck Sharp & Dohme Corp. | Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof |
| US12188063B2 (en) * | 2019-02-08 | 2025-01-07 | Institute Of Science Tokyo | Enzymatic mutant suitable for homogeneous immunoassay method |
| EP3937979A4 (en) * | 2019-03-13 | 2023-03-08 | Merck Sharp & Dohme LLC | COMBINATIONAL ANTI-CANCER THERAPIES WITH CTLA-4 AND PD-1 BLOCKING AGENTS |
| MY204342A (en) | 2019-03-25 | 2024-08-24 | Alteogen Inc | Pharmaceutical composition, comprising human hyaluronidase ph20 variant and drug, for subcutaneous injection |
| TWI878289B (zh) * | 2019-04-23 | 2025-04-01 | 法商賽諾菲公司 | 抗ｃｄ３８抗體和調配物 |
| JP2023500775A (ja) * | 2019-09-23 | 2023-01-11 | メルク・シャープ・アンド・ドーム・エルエルシー | 宿主細胞タンパク質が減少し、ポリソルベート－８０安定性が増加した、抗ｃｔｌａ４モノクローナル抗体を含む方法および組成物 |
| EP4114464A4 (en) * | 2020-03-05 | 2024-05-01 | Merck Sharp & Dohme LLC | Methods for treating cancer using a combination of a pd-1 antagonist, a ctla4 antagonist, and lenvatinib or a pharmaceutically acceptable salt thereof |
| CN115812080A (zh) * | 2020-07-08 | 2023-03-17 | 瑞泽恩制药公司 | 含有抗ctla-4抗体的稳定调配物 |
| US12564642B2 (en) * | 2020-11-10 | 2026-03-03 | Sanofi | CEACAM5 antibody-drug conjugate formulation |
| WO2022165001A1 (en) | 2021-01-29 | 2022-08-04 | Merck Sharp & Dohme Llc | Compositions of programmed death receptor 1 (pd-1) antibodies and methods of obtaining the compositions thereof |
| EP4482868A4 (en) * | 2022-02-24 | 2026-03-04 | Merck Sharp & Dohme Llc | STABLE FORMULATIONS OF A MULTIVALENT, VHH-BASED, CYTOTOXIC, T-LYMPHOCYTE-ASSOCIATED ANTIGEN 4 (CTLA4) BINDING TO HUMANE CTLA4, AND METHOD FOR USE THEREMISSION |
| AU2023259126A1 (en) * | 2022-04-29 | 2024-10-31 | Merck Sharp & Dohme Llc | Stable formulations of anti-ilt4 antibodies or antigen-binding fragments thererof in combination with anti-pd-1 antibodies and methods of use thereof |
| EP4562048A1 (en) * | 2022-07-28 | 2025-06-04 | Merck Sharp & Dohme LLC | Pharmaceutical compositions of programmed death receptor 1 (pd-1) antibodies and ph20 variants or fragments thereof |
| KR20250054235A (ko) * | 2022-07-28 | 2025-04-22 | 머크 샤프 앤드 돔 엘엘씨 | 프로그램화된 사멸 수용체 1 (PD-1) 항체 및 rHuPH20 또는 그의 변이체 또는 단편의 제약 조성물 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1871806A2 (en) * | 2005-03-08 | 2008-01-02 | Pharmacia & Upjohn Company LLC | ANTI-MAdCAM ANTIBODY COMPOSITIONS |
| RU2494107C2 (ru) * | 2005-05-09 | 2013-09-27 | Оно Фармасьютикал Ко., Лтд. | Моноклональные антитела человека к белку программируемой смерти 1 (pd-1) и способы лечения рака с использованием анти-pd-1-антител самостоятельно или в комбинации с другими иммунотерапевтическими средствами |
| AU2010263058A1 (en) * | 2009-06-18 | 2012-01-12 | Wyeth Llc | Lyophilized formulations for small modular immunopharmaceuticals |
| CN102762593B (zh) * | 2009-07-31 | 2015-05-20 | 梅达雷克斯有限责任公司 | 抗btla的完全人抗体 |
| CN105296433B (zh) * | 2014-08-01 | 2018-02-09 | 中山康方生物医药有限公司 | 一种ctla4抗体、其药物组合物及其用途 |
| TN2017000440A1 (en) * | 2015-04-17 | 2019-04-12 | Bristol Myers Squibb Co | Compositions comprising a combination of an anti-pd-1 antibody and another antibody |
| US9995753B2 (en) * | 2015-09-25 | 2018-06-12 | Merck Sharp & Dohme Corp. | Anti-pembrolizumab antibodies |
| SG11201910134SA (en) * | 2017-05-02 | 2019-11-28 | Merck Sharp & Dohme | Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof |
-
2018
- 2018-05-01 SG SG11201910134S patent/SG11201910134SA/en unknown
- 2018-05-01 JP JP2019559826A patent/JP2020518598A/ja not_active Ceased
- 2018-05-01 CN CN201880029175.1A patent/CN110678199B/zh active Active
- 2018-05-01 KR KR1020197035373A patent/KR102624564B1/ko active Active
- 2018-05-01 US US16/609,671 patent/US20200262922A1/en not_active Abandoned
- 2018-05-01 WO PCT/US2018/030420 patent/WO2018204343A1/en not_active Ceased
- 2018-05-01 CA CA3060695A patent/CA3060695A1/en active Pending
- 2018-05-01 UA UAA201911521A patent/UA129862C2/uk unknown
- 2018-05-01 EP EP18793916.0A patent/EP3618866A4/en active Pending
- 2018-05-01 TN TNP/2019/000294A patent/TN2019000294A1/en unknown
- 2018-05-01 MA MA050501A patent/MA50501A/fr unknown
- 2018-05-01 BR BR112019022695-8A patent/BR112019022695A2/pt unknown
- 2018-05-01 MX MX2019013034A patent/MX2019013034A/es unknown
- 2018-05-01 EA EA201992526A patent/EA201992526A1/ru unknown
- 2018-05-01 AU AU2018263837A patent/AU2018263837B2/en active Active
-
2019
- 2019-10-30 CO CONC2019/0012143A patent/CO2019012143A2/es unknown
- 2019-10-30 CL CL2019003143A patent/CL2019003143A1/es unknown
-
2023
- 2023-05-24 JP JP2023085581A patent/JP7653465B2/ja active Active
-
2024
- 2024-09-11 US US18/882,177 patent/US20250074985A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| MX2019013034A (es) | 2020-02-05 |
| KR102624564B1 (ko) | 2024-01-12 |
| US20200262922A1 (en) | 2020-08-20 |
| EP3618866A4 (en) | 2021-07-14 |
| TN2019000294A1 (en) | 2021-05-07 |
| BR112019022695A2 (pt) | 2020-05-26 |
| CN110678199B (zh) | 2025-02-28 |
| MA50501A (fr) | 2020-09-09 |
| EA201992526A1 (ru) | 2020-03-13 |
| AU2018263837A1 (en) | 2019-12-05 |
| CN110678199A (zh) | 2020-01-10 |
| JP7653465B2 (ja) | 2025-03-28 |
| AU2018263837B2 (en) | 2025-02-20 |
| UA129862C2 (uk) | 2025-08-27 |
| SG11201910134SA (en) | 2019-11-28 |
| EP3618866A1 (en) | 2020-03-11 |
| WO2018204343A1 (en) | 2018-11-08 |
| US20250074985A1 (en) | 2025-03-06 |
| JP2023109942A (ja) | 2023-08-08 |
| CA3060695A1 (en) | 2018-11-08 |
| JP2020518598A (ja) | 2020-06-25 |
| CL2019003143A1 (es) | 2020-03-20 |
| KR20190142393A (ko) | 2019-12-26 |
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