CA3048646A1 - Dosing regimens and dosage forms for targeted tgf-b inhibition - Google Patents

Dosing regimens and dosage forms for targeted tgf-b inhibition Download PDF

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Publication number
CA3048646A1
CA3048646A1 CA3048646A CA3048646A CA3048646A1 CA 3048646 A1 CA3048646 A1 CA 3048646A1 CA 3048646 A CA3048646 A CA 3048646A CA 3048646 A CA3048646 A CA 3048646A CA 3048646 A1 CA3048646 A1 CA 3048646A1
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Canada
Prior art keywords
cancer
polypeptide
formulation
seq
drug delivery
Prior art date
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Pending
Application number
CA3048646A
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English (en)
French (fr)
Inventor
Isabelle Dussault
Samer El Bawab
Yulia Vugmeyster
Akash Khandelwal
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.)
Merck Patent GmbH
Original Assignee
Merck Patent GmbH
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
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Application filed by Merck Patent GmbH filed Critical Merck Patent GmbH
Publication of CA3048646A1 publication Critical patent/CA3048646A1/en
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • 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
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/02—Fusion polypeptide containing a localisation/targetting motif containing a signal sequence

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cell Biology (AREA)
  • Toxicology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Endoscopes (AREA)
CA3048646A 2017-01-07 2018-01-05 Dosing regimens and dosage forms for targeted tgf-b inhibition Pending CA3048646A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201762443698P 2017-01-07 2017-01-07
US62/443,698 2017-01-07
US201762581978P 2017-11-06 2017-11-06
US62/581,978 2017-11-06
PCT/US2018/012604 WO2018129331A1 (en) 2017-01-07 2018-01-05 Dosing regimens and dosage forms for targeted tgf-b inhibition

Publications (1)

Publication Number Publication Date
CA3048646A1 true CA3048646A1 (en) 2018-07-12

Family

ID=62791283

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3048646A Pending CA3048646A1 (en) 2017-01-07 2018-01-05 Dosing regimens and dosage forms for targeted tgf-b inhibition

Country Status (15)

Country Link
US (1) US20190330375A1 (https=)
EP (1) EP3565599A4 (https=)
JP (1) JP2020514290A (https=)
KR (1) KR20190102059A (https=)
CN (1) CN110198738A (https=)
AU (1) AU2018205233A1 (https=)
BR (1) BR112019013924A2 (https=)
CA (1) CA3048646A1 (https=)
CL (1) CL2019001871A1 (https=)
IL (1) IL267856A (https=)
MX (1) MX2019008001A (https=)
PH (1) PH12019501574A1 (https=)
RU (1) RU2019124875A (https=)
SG (1) SG11201906157YA (https=)
WO (1) WO2018129331A1 (https=)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HK1225740A1 (zh) 2013-08-22 2017-09-15 Acceleron Pharma Inc. TGF-β受体II型变体及其用途
CN108348578B (zh) 2015-08-04 2022-08-09 阿塞勒隆制药公司 用于治疗骨髓增生性病症的方法
ES2948647T3 (es) 2017-05-04 2023-09-15 Acceleron Pharma Inc Proteínas de fusión del receptor TGF-beta tipo II y usos de las mismas
KR20210022680A (ko) * 2018-06-22 2021-03-03 메르크 파텐트 게엠베하 담도암의 치료에 사용하기 위한 표적화된 TGF-β 억제를 위한 투약 레지멘
AU2019299318A1 (en) * 2018-07-02 2021-01-21 Merck Patent Gmbh Combination therapy with targeted TGF-B inhibition for treatment of advanced non-small cell lung cancer
AU2019301070B2 (en) 2018-07-09 2025-09-11 Precigen, Inc. Fusion constructs and methods of using thereof
US12559539B2 (en) * 2018-11-09 2026-02-24 Jiangsu Hengrui Medicine Co., Ltd. TGF-beta receptor fusion protein pharmaceutical composition and use thereof
CN113677711B (zh) 2019-01-30 2025-05-30 供石公司 TGFβ的LTBP复合特异性抑制剂及其用途
BR112021024820A2 (pt) * 2019-06-10 2022-01-25 Shandong Boan Biotechnology Co Ltd Proteína de fusão bifuncional contra pdl1 e tgfss e uso da mesma
CN112574314A (zh) * 2019-09-30 2021-03-30 和铂医药(苏州)有限公司 一种融合蛋白及其应用
EP4049012A1 (en) * 2019-10-24 2022-08-31 Amgen Inc. Systems and approaches for drug delivery
WO2021084124A1 (en) * 2019-11-01 2021-05-06 Ares Trading S.A. COMBINED INHIBITION OF PD-1, TGFβ AND ATM TOGETHER WITH RADIOTHERAPY FOR THE TREATMENT OF CANCER
WO2021092079A1 (en) 2019-11-05 2021-05-14 Acceleron Pharma Inc. Treatments for systemic sclerosis
BR112022010824A2 (pt) * 2019-12-11 2022-08-23 Wuxi Biologics Ireland Ltd Anticorpo bifuncional contra pd-l1 e tgf¿
JP7730817B6 (ja) * 2019-12-20 2025-09-26 アレス トレーディング ソシエテ アノニム ＩｇＧ：ＴＧＦβＲＩＩ融合タンパク質組成物
CN111118064B (zh) * 2019-12-24 2022-10-25 华南理工大学 一种精子生成障碍动物模型及其制备方法与应用
TW202135862A (zh) 2020-01-11 2021-10-01 美商供石公司 TGFβ抑制劑及其用途
CA3166328A1 (en) 2020-01-11 2021-07-15 Scholar Rock, Inc. Tgf-beta inhibitors and use thereof
US20230093512A1 (en) * 2020-02-18 2023-03-23 Nanjing GenScript Biotech Co., Ltd. Fusion proteins and uses thereof
EP4093779A4 (en) * 2020-02-25 2024-03-06 Wuxi Biologics Ireland Limited BIFUNCTIONAL FUSION PROTEIN AND USES THEREOF
WO2022011256A1 (en) 2020-07-10 2022-01-13 Precigen, Inc. Fusion constructs and methods of using thereof
CN116323657B (zh) * 2020-09-24 2023-12-08 上海齐鲁制药研究中心有限公司 同时靶向PD-L1和TGFβ的双功能分子及其医药用途
US20240148903A1 (en) 2021-03-08 2024-05-09 Nanjing GenScript Biotech Co., Ltd. Delivery of antibody by using dual viral vector system
WO2022204581A2 (en) 2021-03-26 2022-09-29 Scholar Rock, Inc. Tgf-beta inhibitors and use thereof
EP4348260A2 (en) 2021-06-03 2024-04-10 Scholar Rock, Inc. Tgf-beta inhibitors and therapeutic use thereof
PE20241477A1 (es) * 2021-11-19 2024-07-17 Merus Nv Unidades de union multiespecificas que comprenden los dominios de union a pd-1 y tgf-brii
WO2024187051A1 (en) 2023-03-07 2024-09-12 Scholar Rock, Inc. Tgf-beta inhibitors for use for treating resistant or unresponsive cancer in patients
WO2025240343A1 (en) 2024-05-13 2025-11-20 Scholar Rock, Inc. Tgf-beta inhibitors for treating cancer

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5785682A (en) * 1995-03-22 1998-07-28 Abbott Laboratories Pre-filled syringe drug delivery system
CA3253628A1 (en) * 2010-03-05 2025-11-29 The Johns Hopkins University Compositions and methods for targeted immunomodulatory antibodies and fusion proteins
US20130110045A1 (en) * 2011-10-31 2013-05-02 Ming-Yuan Wu Single use intravenous therapy administering device with needle safety covers
PL3489254T3 (pl) * 2012-04-30 2023-01-30 Biocon Limited Ukierunkowujące/immunomodulujące białko fuzyjne i sposoby jego otrzymywania
ES2822665T3 (es) * 2013-05-31 2021-05-04 Merck Sharp & Dohme Terapias de combinación para el cáncer
BR112016014952A2 (pt) * 2014-02-10 2017-09-19 Merck Patent Gmbh Inibição direcionada de tgfbeta
EP4245376A3 (en) * 2014-10-14 2023-12-13 Novartis AG Antibody molecules to pd-l1 and uses thereof
US10828353B2 (en) * 2015-01-31 2020-11-10 The Trustees Of The University Of Pennsylvania Compositions and methods for T cell delivery of therapeutic molecules
EP3770171A1 (en) * 2015-04-03 2021-01-27 XOMA Technology Ltd. Treatment of cancer using inhibitors of tgf-beta and pd-1
ES2835866T5 (es) * 2015-05-12 2024-12-02 Hoffmann La Roche Procedimientos terapéuticos y de diagnóstico para el cáncer

Also Published As

Publication number Publication date
MX2019008001A (es) 2019-09-09
BR112019013924A2 (pt) 2020-02-11
CL2019001871A1 (es) 2019-12-13
JP2020514290A (ja) 2020-05-21
CN110198738A (zh) 2019-09-03
WO2018129331A1 (en) 2018-07-12
KR20190102059A (ko) 2019-09-02
SG11201906157YA (en) 2019-08-27
PH12019501574A1 (en) 2019-11-04
IL267856A (en) 2019-09-26
RU2019124875A (ru) 2021-02-08
EP3565599A1 (en) 2019-11-13
EP3565599A4 (en) 2020-07-01
US20190330375A1 (en) 2019-10-31
RU2019124875A3 (https=) 2021-07-08
AU2018205233A1 (en) 2019-07-11

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