JP2015520188A - Hgh−xten融合タンパク質および成長ホルモン欠乏症の処置におけるその使用 - Google Patents

Hgh−xten融合タンパク質および成長ホルモン欠乏症の処置におけるその使用 Download PDF

Info

Publication number
JP2015520188A
JP2015520188A JP2015516010A JP2015516010A JP2015520188A JP 2015520188 A JP2015520188 A JP 2015520188A JP 2015516010 A JP2015516010 A JP 2015516010A JP 2015516010 A JP2015516010 A JP 2015516010A JP 2015520188 A JP2015520188 A JP 2015520188A
Authority
JP
Japan
Prior art keywords
hgh
xten
fusion protein
bolus dose
sequence
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
JP2015516010A
Other languages
English (en)
Japanese (ja)
Other versions
JP2015520188A5 (enExample
Inventor
ジェフリー エル. クリーランド,
ジェフリー エル. クリーランド,
ジョージ エム. ブライト,
ジョージ エム. ブライト,
エリック ハンフリーズ,
エリック ハンフリーズ,
フォルカー シェレンバーガー,
フォルカー シェレンバーガー,
ジョシュア シルバーマン,
ジョシュア シルバーマン,
ウィレム ピー. ステマー,
ウィレム ピー. ステマー,
チア−ウェイ ワン,
チア−ウェイ ワン,
ネイサン ギーティング,
ネイサン ギーティング,
ベンジャミン スピンク,
ベンジャミン スピンク,
Original Assignee
アムニクス オペレーティング インコーポレイテッド
アムニクス オペレーティング インコーポレイテッド
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 アムニクス オペレーティング インコーポレイテッド, アムニクス オペレーティング インコーポレイテッド filed Critical アムニクス オペレーティング インコーポレイテッド
Publication of JP2015520188A publication Critical patent/JP2015520188A/ja
Publication of JP2015520188A5 publication Critical patent/JP2015520188A5/ja
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • C07K14/575—Hormones
    • C07K14/61—Growth hormone [GH], i.e. somatotropin
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/566—Immunoassay; Biospecific binding assay; Materials therefor using specific carrier or receptor proteins as ligand binding reagents where possible specific carrier or receptor proteins are classified with their target compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Pathology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Toxicology (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2015516010A 2012-06-05 2013-03-14 Hgh−xten融合タンパク質および成長ホルモン欠乏症の処置におけるその使用 Pending JP2015520188A (ja)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201261689390P 2012-06-05 2012-06-05
US61/689,390 2012-06-05
US201261663475P 2012-06-22 2012-06-22
US61/663,475 2012-06-22
US201361763753P 2013-02-12 2013-02-12
US61/763,753 2013-02-12
PCT/US2013/031673 WO2013184216A1 (en) 2012-06-05 2013-03-14 Hgh-xten fusion protein and its use in the treatment of growth hormone deficiency

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2017043512A Division JP2017125051A (ja) 2012-06-05 2017-03-08 Hgh−xten融合タンパク質および成長ホルモン欠乏症の処置におけるその使用

Publications (2)

Publication Number Publication Date
JP2015520188A true JP2015520188A (ja) 2015-07-16
JP2015520188A5 JP2015520188A5 (enExample) 2016-05-12

Family

ID=47998551

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2015516010A Pending JP2015520188A (ja) 2012-06-05 2013-03-14 Hgh−xten融合タンパク質および成長ホルモン欠乏症の処置におけるその使用
JP2017043512A Pending JP2017125051A (ja) 2012-06-05 2017-03-08 Hgh−xten融合タンパク質および成長ホルモン欠乏症の処置におけるその使用

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2017043512A Pending JP2017125051A (ja) 2012-06-05 2017-03-08 Hgh−xten融合タンパク質および成長ホルモン欠乏症の処置におけるその使用

Country Status (17)

Country Link
US (2) US20140162949A1 (enExample)
EP (1) EP2858664B1 (enExample)
JP (2) JP2015520188A (enExample)
KR (1) KR20150021072A (enExample)
CN (2) CN107320719A (enExample)
AU (1) AU2013272220A1 (enExample)
BR (1) BR112014030404A2 (enExample)
CA (1) CA2875827A1 (enExample)
DK (1) DK2858664T3 (enExample)
ES (1) ES2733220T3 (enExample)
HK (1) HK1208629A1 (enExample)
IL (1) IL236070A0 (enExample)
MX (1) MX2014014927A (enExample)
NZ (1) NZ702557A (enExample)
PH (1) PH12014502738A1 (enExample)
SG (1) SG11201408152VA (enExample)
WO (1) WO2013184216A1 (enExample)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7855279B2 (en) 2005-09-27 2010-12-21 Amunix Operating, Inc. Unstructured recombinant polymers and uses thereof
DK3178835T3 (da) 2009-02-03 2019-06-24 Amunix Pharmaceuticals Inc Forlængede rekombinante polypeptider og sammensætninger omfattende samme
US9849188B2 (en) 2009-06-08 2017-12-26 Amunix Operating Inc. Growth hormone polypeptides and methods of making and using same
WO2014164568A1 (en) * 2013-03-11 2014-10-09 Amunix Operating Inc. Treatment of pediatric growth hormone deficiency with human growth hormone analogues
IL319047A (en) 2015-08-28 2025-04-01 Amunix Operating Inc Chimeric polypeptide composition and methods for its preparation and use
WO2017136583A1 (en) 2016-02-02 2017-08-10 Versartis, Inc. Growth hormone treatment adherence system
EP3416677B1 (en) 2016-02-17 2022-08-03 Genexine, Inc. Pharmaceutical composition comprising recombinant hgh for the treatment of growth hormone deficiency
WO2017142331A1 (en) * 2016-02-17 2017-08-24 Genexine, Inc. Pharmaceutical composition comprising recombinant hgh for the treatment of growth hormone deficiency
WO2018022939A1 (en) * 2016-07-27 2018-02-01 Amunix Operating Inc. Treatment of adult growth hormone deficiency with human growth hormone analogues
CN118105512A (zh) 2016-08-30 2024-05-31 株式会社吉耐森 含有hGH融合蛋白的治疗生长激素缺乏症的药物组合物
US10738338B2 (en) 2016-10-18 2020-08-11 The Research Foundation for the State University Method and composition for biocatalytic protein-oligonucleotide conjugation and protein-oligonucleotide conjugate
KR20260039804A (ko) 2017-12-21 2026-03-20 아뮤닉스 파마슈티컬스, 인크. 유리 세그먼트 및 이것을 포함하는 결합 조성물
MY204234A (en) 2018-08-27 2024-08-16 Regeneron Pharma Use of raman spectroscopy in downstream purification
WO2021136223A1 (en) 2019-12-31 2021-07-08 Beijing Ql Biopharmaceutical Co., Ltd. Fusion proteins of glp-1 and gdf15 and conjugates thereof
CN113728013B (zh) 2020-01-11 2022-06-14 北京质肽生物医药科技有限公司 Glp-1和fgf21的融合蛋白的缀合物
CA3193453A1 (en) 2020-09-30 2022-04-07 Beijing Ql Biopharmaceutical Co., Ltd. Polypeptide conjugates and methods of uses
CN116554343B (zh) * 2022-01-30 2024-07-12 领诺(上海)医药科技有限公司 一种长效重组人生长激素及其应用
EP4323413A4 (en) 2022-03-30 2025-10-15 Beijing Ql Biopharmaceutical Co Ltd LIQUID PHARMACEUTICAL COMPOSITIONS OF POLYPEPTIDE CONJUGATES AND METHODS OF USE THEREOF
CN116003632B (zh) * 2022-12-07 2026-02-24 北京大学 长效缓释型人重组生长激素融合蛋白及其药物组合物和应用

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010144502A2 (en) * 2009-06-08 2010-12-16 Amunix Operating Inc. Growth hormone polypeptides and methods of making and using same

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4898830A (en) 1979-07-05 1990-02-06 Genentech, Inc. Human growth hormone DNA
US5206161A (en) 1991-02-01 1993-04-27 Genentech, Inc. Human plasma carboxypeptidase B
EP0983303B1 (en) 1997-05-21 2006-03-08 Biovation Limited Method for the production of non-immunogenic proteins
US6406632B1 (en) 1998-04-03 2002-06-18 Symyx Technologies, Inc. Rapid characterization of polymers
GB9815157D0 (en) 1998-07-13 1998-09-09 Metron Designs Ltd High resolution pulse width setting from relatively low frequency clocks
US20030228309A1 (en) 2000-11-08 2003-12-11 Theodora Salcedo Antibodies that immunospecifically bind to TRAIL receptors
US6992174B2 (en) 2001-03-30 2006-01-31 Emd Lexigen Research Center Corp. Reducing the immunogenicity of fusion proteins
US7294513B2 (en) 2002-07-24 2007-11-13 Wyatt Technology Corporation Method and apparatus for characterizing solutions of small particles
US8680050B2 (en) * 2009-02-03 2014-03-25 Amunix Operating Inc. Growth hormone polypeptides fused to extended recombinant polypeptides and methods of making and using same
US8703717B2 (en) * 2009-02-03 2014-04-22 Amunix Operating Inc. Growth hormone polypeptides and methods of making and using same
DK3178835T3 (da) * 2009-02-03 2019-06-24 Amunix Pharmaceuticals Inc Forlængede rekombinante polypeptider og sammensætninger omfattende samme

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010144502A2 (en) * 2009-06-08 2010-12-16 Amunix Operating Inc. Growth hormone polypeptides and methods of making and using same

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
"VRS-317 IN ADULT SUBJECTS WITH GROWTH HORMONE DEFICIENCY", CLINICALTRIALS. GOV ARCHIVE [ONLINE], JPN5015007481, 23 May 2011 (2011-05-23), ISSN: 0003457506 *
CLELAND JL: "A NOVEL HUMAN GROWTH HORMONE XTEN CONSTRUCT (VRS-317) FOR ONCE-A-MONTH SUBCUTANEOUS 以下備考", ENDOCR REV. [ONLINE], vol. V32, JPN5015007477, June 2011 (2011-06-01), ISSN: 0003457504 *
ENDOCRINE JOURNAL, vol. 57, no. 2, JPN6016047555, 2010, pages 618, ISSN: 0003457505 *
J CLIN ENDOCRINOL METAB, vol. 87, no. 10, JPN6016047558, 2002, pages 4508 - 4514, ISSN: 0003457508 *
NATURE BIOTECHNOLOGY, vol. 27, no. 12, JPN6016047556, 2009, pages 1186 - 1190, ISSN: 0003457507 *

Also Published As

Publication number Publication date
JP2017125051A (ja) 2017-07-20
BR112014030404A2 (pt) 2017-06-27
PH12014502738A1 (en) 2015-02-02
CN107320719A (zh) 2017-11-07
ES2733220T3 (es) 2019-11-28
US20140162949A1 (en) 2014-06-12
HK1208629A1 (en) 2016-03-11
KR20150021072A (ko) 2015-02-27
SG11201408152VA (en) 2015-01-29
EP2858664B1 (en) 2019-05-08
MX2014014927A (es) 2015-05-15
AU2013272220A1 (en) 2015-01-15
IL236070A0 (en) 2015-01-29
CA2875827A1 (en) 2013-12-12
NZ702557A (en) 2017-06-30
EP2858664A1 (en) 2015-04-15
WO2013184216A1 (en) 2013-12-12
US20180051063A1 (en) 2018-02-22
DK2858664T3 (da) 2019-07-08
CN104519903A (zh) 2015-04-15

Similar Documents

Publication Publication Date Title
EP2858664B1 (en) Hgh-xten fusion protein and its use in the treatment of growth hormone deficiency
US20160158321A1 (en) Treatment of pediatric growth hormone deficiency with human growth hormone analogues
JP6206972B2 (ja) グルカゴン様ペプチド−2組成物およびその作製法および使用法
JP5189723B2 (ja) 骨関連疾患及び栄養関連疾患の治療、予防、診断及び予後のためにglpを使用する方法
JP5805634B2 (ja) 成長ホルモンポリペプチド並びにその作成及び使用方法
EP0914341B1 (en) Antagonists of intestinotrophic glp-2 peptides
CN102119033B (zh) 用于增强促生长素抑制素免疫原性的组合物和方法
JP2004524268A5 (enExample)
WO2016109823A1 (en) Treatment of pediatric growth hormone deficiency with human growth hormone analogues
CN105658232A (zh) 使用白细胞介素-10治疗疾病和病症的方法
TW202136289A (zh) 新穎之胰島素類似物及其用途
US20070135345A1 (en) Use of GLP-2 for the treatment or prevention, of bone-related disorders
US20200000884A1 (en) Treatment of adult growth hormone deficiency with human growth hormone analogues
WO2014014819A2 (en) Methods of treating glucose metabolism disorders
TW202440649A (zh) 一種包含glp-1 融合蛋白的藥物製劑及其用途
WO2024141054A1 (zh) 包含融合蛋白的药物组合物及其用途

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20150209

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160314

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20160314

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20161209

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20170308

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20170621