CA3137464A1 - Stable, low-viscosity antibody formulations and uses thereof - Google Patents

Stable, low-viscosity antibody formulations and uses thereof Download PDF

Info

Publication number
CA3137464A1
CA3137464A1 CA3137464A CA3137464A CA3137464A1 CA 3137464 A1 CA3137464 A1 CA 3137464A1 CA 3137464 A CA3137464 A CA 3137464A CA 3137464 A CA3137464 A CA 3137464A CA 3137464 A1 CA3137464 A1 CA 3137464A1
Authority
CA
Canada
Prior art keywords
formulation
hours
antibody
days
months
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
Application number
CA3137464A
Other languages
English (en)
French (fr)
Inventor
Atul SALUJA
Manjori GANGULY
Kelvin REMBERT
Yatin Gokarn
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi SA
Original Assignee
Sanofi SA
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=70295163&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA3137464(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi SA filed Critical Sanofi SA
Publication of CA3137464A1 publication Critical patent/CA3137464A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • C07K16/2866Immunoglobulins [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 cytokines, lymphokines, interferons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71Decreased effector function due to an Fc-modification

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
CA3137464A 2019-04-23 2020-04-23 Stable, low-viscosity antibody formulations and uses thereof Pending CA3137464A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962837518P 2019-04-23 2019-04-23
US62/837,518 2019-04-23
EP20305145 2020-02-17
EP20305145.3 2020-02-17
PCT/EP2020/061340 WO2020216847A1 (en) 2019-04-23 2020-04-23 Stable, low-viscosity antibody formulations and uses thereof

Publications (1)

Publication Number Publication Date
CA3137464A1 true CA3137464A1 (en) 2020-10-29

Family

ID=70295163

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3137464A Pending CA3137464A1 (en) 2019-04-23 2020-04-23 Stable, low-viscosity antibody formulations and uses thereof

Country Status (15)

Country Link
US (1) US20220218607A1 (https=)
EP (1) EP3958896A1 (https=)
JP (2) JP7671697B2 (https=)
KR (1) KR20220004104A (https=)
CN (1) CN114286690A (https=)
AU (1) AU2020262231A1 (https=)
BR (1) BR112021021099A2 (https=)
CA (1) CA3137464A1 (https=)
CO (1) CO2021015561A2 (https=)
IL (1) IL287435A (https=)
MA (1) MA55750A (https=)
MX (1) MX2021012968A (https=)
SG (1) SG11202111740PA (https=)
TW (1) TW202108171A (https=)
WO (1) WO2020216847A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11655302B2 (en) 2019-06-10 2023-05-23 Sanofi Anti-CD38 antibodies and formulations
IL293563A (en) * 2019-12-05 2022-08-01 Sanofi Aventis Us Llc Formulations of anti-cd38 antibodies for subcutaneous administration
JP2024546152A (ja) * 2021-12-16 2024-12-17 上海宝済薬業股▲ふん▼有限公司 免疫グロブリン分解酵素による切断に対抗するFc変異体
WO2024023843A1 (en) * 2022-07-26 2024-02-01 Dr. Reddy’S Laboratories Limited A pharmaceutical formulation of a therapeuticantibody and preparations thereof
WO2026006689A2 (en) 2024-06-28 2026-01-02 Firefly Bio, Inc. Bcl-xl degrader antibody conjugates and uses thereof

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5460944A (en) * 1991-10-28 1995-10-24 Boehringer Mannheim Gmbh Storable protein solution
US7612181B2 (en) 2005-08-19 2009-11-03 Abbott Laboratories Dual variable domain immunoglobulin and uses thereof
CA2790018C (en) * 2006-12-21 2015-02-03 Amgen Inc. Formulations
WO2009120684A1 (en) * 2008-03-25 2009-10-01 Medimmune, Llc Antibody formulation
CN102149825B (zh) 2008-07-08 2015-07-22 Abbvie公司 前列腺素e2双重可变结构域免疫球蛋白及其用途
WO2011028811A2 (en) 2009-09-01 2011-03-10 Abbott Laboratories Dual variable domain immunoglobulins and uses thereof
BR112012008833A2 (pt) 2009-10-15 2015-09-08 Abbott Lab imunoglobulinas de dominio variavel duplo e usos das mesmas
UY32979A (es) 2009-10-28 2011-02-28 Abbott Lab Inmunoglobulinas con dominio variable dual y usos de las mismas
AR080428A1 (es) * 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
EP3409289B1 (en) * 2010-02-26 2020-09-30 Novo Nordisk A/S Stable antibody containing compositions
NZ602685A (en) * 2010-03-01 2014-10-31 Cytodyn Inc Concentrated protein formulations and uses thereof
EP3252072A3 (en) 2010-08-03 2018-03-14 AbbVie Inc. Dual variable domain immunoglobulins and uses thereof
JP6345123B2 (ja) * 2012-02-16 2018-06-20 サンタラス, インコーポレイテッド 抗vla1(cd49a)抗体医薬組成物
DK3199552T3 (da) * 2012-11-20 2020-03-30 Sanofi Sa Anti-ceacam5-antistoffer og anvendelser heraf
US20160058863A1 (en) * 2014-09-03 2016-03-03 Board Of Regents, The University Of Texas System Low viscosity concentrated protein dispersions
WO2018119142A1 (en) * 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
TW201837053A (zh) * 2016-12-22 2018-10-16 法商賽諾菲公司 具有消耗活性的人源化cxcr3抗體及其使用方法

Also Published As

Publication number Publication date
CN114286690A (zh) 2022-04-05
SG11202111740PA (en) 2021-11-29
CO2021015561A2 (es) 2021-12-10
TW202108171A (zh) 2021-03-01
JP2025087851A (ja) 2025-06-10
EP3958896A1 (en) 2022-03-02
KR20220004104A (ko) 2022-01-11
JP7671697B2 (ja) 2025-05-02
BR112021021099A2 (pt) 2021-12-14
US20220218607A1 (en) 2022-07-14
IL287435A (en) 2021-12-01
MA55750A (fr) 2022-03-02
WO2020216847A1 (en) 2020-10-29
AU2020262231A1 (en) 2021-12-16
MX2021012968A (es) 2022-01-18
JP2022530050A (ja) 2022-06-27

Similar Documents

Publication Publication Date Title
CA3137464A1 (en) Stable, low-viscosity antibody formulations and uses thereof
JP7627730B2 (ja) 低pH医薬抗体製剤
CN109071657B (zh) 包含双特异性抗体构建体的药物组合物
ES2788515T3 (es) Formulaciones liofilizadas y acuosas de anticuerpos anti-CD40
JP7126454B2 (ja) 医薬組成物
KR102372245B1 (ko) 항체-약물 접합체 동결건조 제제
TWI840325B (zh) 包含T細胞接合抗體構築體之低pH值醫藥組成物
JP5767340B2 (ja) 生物薬剤を含む医薬製剤
TWI682788B (zh) 包含gm-csf中和化合物之液態調配物
JP2005527503A (ja) ポリペプチド製剤
KR102106914B1 (ko) Gm-csf를 중화하는 화합물을 포함하는 액체 제제
TW201028167A (en) Pharmaceutical composition
CN111417385A (zh) 减少喷雾干燥的蛋白质制剂的重构时间的方法
JPWO2008029908A1 (ja) 抗体を含有する安定な凍結乾燥医薬製剤
WO2014141149A1 (en) Formulations with reduced viscosity
CN119095584A (zh) 抗gm-csf抗体的液体药物配制品及其用途
US20260125458A1 (en) Bispecific anti-vegf/ang2 antibody formulation
CN116510006A (zh) 抗trbv9抗体的药物组合物及其用途
WO2026067821A1 (zh) 一种抗pd-1抗体制剂及其制备方法和用途
OA21977A (en) Pharmaceutical composition of anti-TRBV9 antibody and use thereof.

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20220917

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: 20250207

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 5TH ANNIV.) - STANDARD

Year of fee payment: 5

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: 20250422

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 PAID IN FULL

Effective date: 20250422

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: 20250603

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: 20250604

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: 20250724

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: 20250724

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 6TH ANNIV.) - STANDARD

Year of fee payment: 6

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: 20260415

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 PAID IN FULL

Effective date: 20260415