JP2025500483A - 抗ｔｉｇｉｔ抗体の臨床製剤 - Google Patents

抗ｔｉｇｉｔ抗体の臨床製剤 Download PDF

Info

Publication number
JP2025500483A
JP2025500483A JP2024538263A JP2024538263A JP2025500483A JP 2025500483 A JP2025500483 A JP 2025500483A JP 2024538263 A JP2024538263 A JP 2024538263A JP 2024538263 A JP2024538263 A JP 2024538263A JP 2025500483 A JP2025500483 A JP 2025500483A
Authority
JP
Japan
Prior art keywords
cancer
monoclonal antibody
seq
pharmaceutical formulation
liquid pharmaceutical
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
JP2024538263A
Other languages
English (en)
Japanese (ja)
Other versions
JP2025500483A5 (https=
Inventor
イアン チュン－ティ シエ，
アン マリー ウォイズ，
キャサリン ローラ チューディ，
ロビン マリア スーリン，
ルチャ スダカール サーネ，
ホイ ミン フィリス チャン，
シアオホイ ウェン，
イザベル アン ルーニー，
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.)
Genentech Inc
Original Assignee
Genentech Inc
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
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of JP2025500483A publication Critical patent/JP2025500483A/ja
Publication of JP2025500483A5 publication Critical patent/JP2025500483A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • 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
    • 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
    • C07K16/2827—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 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
    • A61K2039/507—Comprising a combination of two or more separate 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01035—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (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)
JP2024538263A 2021-12-22 2022-12-21 抗ｔｉｇｉｔ抗体の臨床製剤 Pending JP2025500483A (ja)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US202163292863P 2021-12-22 2021-12-22
US63/292,863 2021-12-22
US202263383451P 2022-11-11 2022-11-11
US63/383,451 2022-11-11
US202263387229P 2022-12-13 2022-12-13
US63/387,229 2022-12-13
PCT/US2022/082139 WO2023122665A1 (en) 2021-12-22 2022-12-21 Clinical formulations of anti-tigit antibodies

Publications (2)

Publication Number Publication Date
JP2025500483A true JP2025500483A (ja) 2025-01-09
JP2025500483A5 JP2025500483A5 (https=) 2025-12-24

Family

ID=85199491

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024538263A Pending JP2025500483A (ja) 2021-12-22 2022-12-21 抗ｔｉｇｉｔ抗体の臨床製剤

Country Status (10)

Country Link
US (1) US20240408009A1 (https=)
EP (1) EP4452320A1 (https=)
JP (1) JP2025500483A (https=)
KR (1) KR20240121771A (https=)
AU (1) AU2022417501A1 (https=)
CA (1) CA3242136A1 (https=)
IL (1) IL313658A (https=)
MX (1) MX2024007749A (https=)
TW (1) TW202330034A (https=)
WO (1) WO2023122665A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202515614A (zh) 2023-08-25 2025-04-16 美商建南德克公司 治療非小細胞肺癌之方法及組成物
WO2025174933A1 (en) 2024-02-14 2025-08-21 Genentech, Inc. Methods for treatment of pancreatic cancer with anti-pd-l1 ab, anti-tigit ab, gemcitabine and nab-placlitaxel

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6075181A (en) 1990-01-12 2000-06-13 Abgenix, Inc. Human antibodies derived from immunized xenomice
US6150584A (en) 1990-01-12 2000-11-21 Abgenix, Inc. Human antibodies derived from immunized xenomice
US5641870A (en) 1995-04-20 1997-06-24 Genentech, Inc. Low pH hydrophobic interaction chromatography for antibody purification
KR20220113414A (ko) 2019-12-09 2022-08-12 제넨테크, 인크. 항-pd-l1 항체 제제
CN115052622B (zh) * 2020-01-21 2026-03-06 夏尔巴生物技术(杭州)有限公司 重组全人源抗tigit单克隆抗体制剂及其制备方法和用途
TW202142230A (zh) * 2020-01-27 2021-11-16 美商建南德克公司 用於以抗ｔｉｇｉｔ拮抗體抗體治療癌症之方法

Also Published As

Publication number Publication date
TW202330034A (zh) 2023-08-01
AU2022417501A1 (en) 2024-07-04
CA3242136A1 (en) 2023-06-29
IL313658A (en) 2024-08-01
MX2024007749A (es) 2024-07-01
EP4452320A1 (en) 2024-10-30
WO2023122665A1 (en) 2023-06-29
US20240408009A1 (en) 2024-12-12
KR20240121771A (ko) 2024-08-09

Similar Documents

Publication Publication Date Title
US20250034263A1 (en) Formulation for anti-alpha4beta7 antibody
JP7579227B2 (ja) 瘻孔を伴うクローン病の治療用ベドリズマブ
TWI664980B (zh) 抗-α4β7抗體之用途
TWI733664B (zh) 包含抗ｐｄ１抗體及另一種抗體之組合的組合物
JP7312188B2 (ja) 抗ｐｄ－１抗体組成物
US20240408009A1 (en) Clinical formulations of anti-tigit antibodies
CN111212662A (zh) 治疗癌症的组合疗法
KR20250029919A (ko) 갈렉틴-9를 억제하는 항체를 사용한 혈액학적 악성종양의 치료
CN118871131A (zh) 抗tigit抗体的临床制剂
JP2026513259A (ja) 抗ｔｉｇｉｔ抗体を用いた腫瘍の治療方法
WO2025218746A1 (en) Methods of treating rheumatoid arthritis
WO2025085792A1 (en) Treatment of hematological malignancies with antibodies inhibiting galectin-9
CA3248485A1 (en) Stable high concentration sodium chloride formulations containing pd-1 antibody and methods of use thereof
ES3060110T3 (en) Formulation for anti-alpha4beta7 antibody
WO2023107100A1 (en) Methods and treatment for multiple myeloma involving antibodies to il-18
HK40029586A (en) Combination therapies for treating cancers
HK1195485A (en) FORMULATION FOR ANTI-α4β7 ANTIBODY

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20251216

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20251216