CA3174778A1 - High concentration anti-a.beta. protofibril antibody formulations and methods of use thereof - Google Patents
High concentration anti-a.beta. protofibril antibody formulations and methods of use thereofInfo
- Publication number
- CA3174778A1 CA3174778A1 CA3174778A CA3174778A CA3174778A1 CA 3174778 A1 CA3174778 A1 CA 3174778A1 CA 3174778 A CA3174778 A CA 3174778A CA 3174778 A CA3174778 A CA 3174778A CA 3174778 A1 CA3174778 A1 CA 3174778A1
- Authority
- CA
- Canada
- Prior art keywords
- arginine
- pharmaceutical formulation
- concentration
- fragment
- seq
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
Links
Classifications
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/133—Amines having hydroxy groups, e.g. sphingosine
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/26—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hospice & Palliative Care (AREA)
- Psychiatry (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Cosmetics (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202062992746P | 2020-03-20 | 2020-03-20 | |
| US62/992,746 | 2020-03-20 | ||
| US202063027263P | 2020-05-19 | 2020-05-19 | |
| US63/027,263 | 2020-05-19 | ||
| PCT/IB2021/000155 WO2021186245A1 (en) | 2020-03-20 | 2021-03-19 | HIGH CONCENTRATION ANTI-Aß PROTOFIBRIL ANTIBODY FORMULATIONS AND METHODS OF USE THEREOF |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA3174778A1 true CA3174778A1 (en) | 2021-09-23 |
Family
ID=75746958
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3174778A Pending CA3174778A1 (en) | 2020-03-20 | 2021-03-19 | High concentration anti-a.beta. protofibril antibody formulations and methods of use thereof |
Country Status (27)
| Country | Link |
|---|---|
| US (1) | US20230183328A1 (https=) |
| EP (2) | EP4121007B1 (https=) |
| JP (2) | JP7689141B2 (https=) |
| KR (1) | KR20220156534A (https=) |
| CN (1) | CN115315251A (https=) |
| AU (1) | AU2021238951A1 (https=) |
| BR (1) | BR112022018766A2 (https=) |
| CA (1) | CA3174778A1 (https=) |
| CL (2) | CL2022002517A1 (https=) |
| CO (1) | CO2022012916A2 (https=) |
| DK (1) | DK4121007T3 (https=) |
| ES (1) | ES3041762T3 (https=) |
| FI (1) | FI4121007T3 (https=) |
| HR (1) | HRP20251087T1 (https=) |
| HU (1) | HUE072937T2 (https=) |
| IL (2) | IL295383B1 (https=) |
| LT (1) | LT4121007T (https=) |
| MA (1) | MA59082B1 (https=) |
| MD (1) | MD4121007T2 (https=) |
| MX (1) | MX2022011101A (https=) |
| PH (1) | PH12022552172A1 (https=) |
| PL (1) | PL4121007T3 (https=) |
| PT (1) | PT4121007T (https=) |
| RS (1) | RS67249B1 (https=) |
| SI (1) | SI4121007T1 (https=) |
| SM (1) | SMT202500350T1 (https=) |
| WO (1) | WO2021186245A1 (https=) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20230039734A (ko) | 2020-07-23 | 2023-03-21 | 오타이르 프로테나 리미티드 | 항-Aβ 항체 |
| AU2022307687A1 (en) | 2021-07-09 | 2024-01-04 | Eisai R&D Management Co., Ltd. | Biomarkers for alzheimer's disease treatment |
| AU2022439338A1 (en) | 2022-02-02 | 2024-08-15 | Eisai R&D Management Co., Ltd. | Methods of treatment using p-tau181 level |
| JP2025539394A (ja) | 2022-11-28 | 2025-12-05 | エーザイ・アール・アンド・ディー・マネジメント株式会社 | タウｐｅｔレベルを使用する治療の方法 |
| KR20260022396A (ko) | 2023-06-09 | 2026-02-19 | 에자이 알앤드디 매니지먼트 가부시키가이샤 | 항-Aβ 프로토피브릴 항체를 사용한 치료 방법 |
| WO2026015877A1 (en) | 2024-07-12 | 2026-01-15 | Eisai R&D Management Co., Ltd. | Fluid biomarker |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| CN118370815A (zh) | 2017-08-22 | 2024-07-23 | 渤健马萨诸塞州股份有限公司 | 含有抗β淀粉样蛋白抗体的药物组合物 |
| US20210324056A1 (en) | 2018-07-24 | 2021-10-21 | Eisai R&D Management Co., Ltd. | Methods of treatment and prevention of alzheimer's disease |
-
2021
- 2021-03-19 RS RS20250922A patent/RS67249B1/sr unknown
- 2021-03-19 EP EP21722538.2A patent/EP4121007B1/en active Active
- 2021-03-19 BR BR112022018766A patent/BR112022018766A2/pt unknown
- 2021-03-19 KR KR1020227030919A patent/KR20220156534A/ko active Pending
- 2021-03-19 PL PL21722538.2T patent/PL4121007T3/pl unknown
- 2021-03-19 MX MX2022011101A patent/MX2022011101A/es unknown
- 2021-03-19 IL IL295383A patent/IL295383B1/en unknown
- 2021-03-19 FI FIEP21722538.2T patent/FI4121007T3/fi active
- 2021-03-19 WO PCT/IB2021/000155 patent/WO2021186245A1/en not_active Ceased
- 2021-03-19 CN CN202180019180.6A patent/CN115315251A/zh active Pending
- 2021-03-19 PH PH1/2022/552172A patent/PH12022552172A1/en unknown
- 2021-03-19 AU AU2021238951A patent/AU2021238951A1/en active Pending
- 2021-03-19 US US17/906,660 patent/US20230183328A1/en active Pending
- 2021-03-19 MD MDE20230104T patent/MD4121007T2/ro unknown
- 2021-03-19 SI SI202130347T patent/SI4121007T1/sl unknown
- 2021-03-19 PT PT217225382T patent/PT4121007T/pt unknown
- 2021-03-19 IL IL326613A patent/IL326613A/en unknown
- 2021-03-19 DK DK21722538.2T patent/DK4121007T3/da active
- 2021-03-19 EP EP23179487.6A patent/EP4252777A3/en active Pending
- 2021-03-19 SM SM20250350T patent/SMT202500350T1/it unknown
- 2021-03-19 JP JP2022556091A patent/JP7689141B2/ja active Active
- 2021-03-19 HU HUE21722538A patent/HUE072937T2/hu unknown
- 2021-03-19 LT LTEPPCT/IB2021/000155T patent/LT4121007T/lt unknown
- 2021-03-19 MA MA59082A patent/MA59082B1/fr unknown
- 2021-03-19 HR HRP20251087TT patent/HRP20251087T1/hr unknown
- 2021-03-19 CA CA3174778A patent/CA3174778A1/en active Pending
- 2021-03-19 ES ES21722538T patent/ES3041762T3/es active Active
-
2022
- 2022-09-12 CO CONC2022/0012916A patent/CO2022012916A2/es unknown
- 2022-09-14 CL CL2022002517A patent/CL2022002517A1/es unknown
-
2024
- 2024-11-08 CL CL2024003428A patent/CL2024003428A1/es unknown
-
2025
- 2025-04-10 JP JP2025064827A patent/JP2025111516A/ja active Pending
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA3174778A1 (en) | High concentration anti-a.beta. protofibril antibody formulations and methods of use thereof | |
| US20220251210A1 (en) | Formulation comprising anti-cd47/pd-l1 bispecific antibody, method for preparing same and use thereof | |
| US20100209437A1 (en) | Anti-CD3 Antibody Fromulations | |
| US9457089B2 (en) | Highly concentrated aqueous protein solution with reduced viscosity | |
| US10472416B2 (en) | IL-17 antibody formulations and methods of treatment using same | |
| HK1211840A1 (en) | Stable, low viscosity antibody formulation | |
| TWI764097B (zh) | 包含抗ｃｄ４７抗體的製劑及其製備方法和用途 | |
| JP7183268B2 (ja) | 等張化剤としてリジン塩を含有するアフリベルセプト製剤及びその使用 | |
| PT2445482E (pt) | Método para preparar uma composição de igg enriquecida a partir do plasma | |
| JP2015536930A (ja) | 抗体の高濃度液体製剤の製造方法 | |
| US20250282882A1 (en) | Pharmaceutical formulation comprising anti-ox40 monoclonal antibody | |
| US20230080706A1 (en) | Recombinant fully human anti-tigit monoclonal antibody formulation, method for preparing same and use thereof | |
| HK40102754A (en) | High concentration anti-ass protofibril antibody formulations and methods of use thereof | |
| RU2846725C1 (ru) | ВЫСОКОКОНЦЕНТРИРОВАННЫЕ СОСТАВЫ НА ОСНОВЕ АНТИТЕЛ К ПРОТОФИБРИЛЛАМ Аβ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ | |
| HK40085437B (en) | High concentration anti-amyloid beta peptide protofibril antibody formulations and methods of use thereof | |
| HK40085437A (en) | High concentration anti-amyloid beta peptide protofibril antibody formulations and methods of use thereof | |
| EA052372B1 (ru) | Фармацевтическая композиция, содержащая моноклональное антитело к ox40 | |
| HK40114522A (zh) | 包含抗-ox40单克隆抗体的药物制剂 | |
| HK1230094A1 (en) | Pharmaceutical composition for use in prevention and/or treatment of disease that develops or progresses as a result of decrease or loss of activity of blood coagulation factor viii and/or activated blood coagulation factor viii | |
| HK1257781A1 (zh) | 含抗-pd-l1抗体avelumab的水性药物制剂 | |
| HK1233918A1 (en) | Stable, low viscosity antibody formulation | |
| HK1233918A (en) | Stable, low viscosity antibody formulation |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20220906 |
|
| P11 | Amendment of application requested |
Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - VOLUNTARY AMENDMENT Effective date: 20240830 |
|
| D11 | Substantive examination requested |
Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D11-D131 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR CONTINUED EXAMINATION (RCE) RECEIVED Effective date: 20241018 |
|
| W00 | Other event occurred |
Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT Effective date: 20241021 |
|
| MFA | Maintenance fee for application paid |
Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 4TH ANNIV.) - STANDARD Year of fee payment: 4 |
|
| U00 | Fee paid |
Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED Effective date: 20250314 |
|
| U11 | Full renewal or maintenance fee paid |
Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT Effective date: 20250314 Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL Effective date: 20250314 |
|
| D00 | Search and/or examination requested or commenced |
Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D00-D148 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR CONTINUED EXAMINATION (NOA/CNOA) DETERMINED COMPLIANT Effective date: 20250711 Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D00-D174 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR CONTINUED EXAMINATION REQUIREMENTS DETERMINED COMPLIANT Effective date: 20250711 |
|
| P11 | Amendment of application requested |
Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT Effective date: 20250711 |
|
| P12 | Request for amendment of application rejected |
Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P12-P147 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REJECTED AMENDMENT AFTER RCE - PREVIOUSLY ACCEPTED AMENDMENT AFTER ALLOWANCE REJECTED Effective date: 20250711 |
|
| P13 | Application amended |
Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED Effective date: 20250711 |
|
| W00 | Other event occurred |
Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT Effective date: 20250711 |
|
| D15 | Examination report completed |
Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT Effective date: 20251030 |
|
| P11 | Amendment of application requested |
Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - RESPONSE TO EXAMINER'S REQUISITION Effective date: 20260302 |