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公开(公告)号：US20240101598A1
公开(公告)日：2024-03-28
申请号：US18039688
申请日：2021-12-17
申请人： RICHTER GEDEON NYRT.
CPC分类号： C07K1/36 , C07K14/524 , C07K2319/30
摘要： The present invention relates to new methods for the purification of Fc-peptide fusion protein (peptibodies) derived from inclusion bodies after prokaryotic expression. In particular, it relates to chromatographic methods of the fusion peptides after refolding and dimerization comprising affinity capture, intermediate and polishing chromatographies. These methods facilitate the decrease of product-related impurities, such as sulfide variants or charge variants of the Fc-peptide fusion proteins in the final product. In addition, the present invention relates to specific conditions and selected buffers avoiding aggregation, precipitation, and degradation of the Fc-peptide fusion proteins. Finally, the methods of the present invention result in a formulated pharmaceutical composition or a pre-stage pharmaceutical composition containing an Fc-peptide fusion protein of high purity.
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公开(公告)号：US20170172121A1
公开(公告)日：2017-06-22
申请号：US15397628
申请日：2017-01-03
申请人： Regeneron Pharmaceuticals, Inc. , Yale University , Institute for Research in Biomedicine (IRB)
发明人： Sean Stevens , Andrew J. Murphy , Richard Flavell , Elizabeth Eynon , Jorge Galan , Tim Willinger , Markus Manz , Anthony Rongvaux , George D. Yancopoulos
IPC分类号： A01K67/027
CPC分类号： A01K67/0278 , A01K67/0271 , A01K67/0275 , A01K2207/12 , A01K2207/15 , A01K2217/072 , A01K2217/075 , A01K2217/15 , A01K2227/105 , A01K2267/03 , A01K2267/0331 , A01K2267/0337 , A01K2267/0381 , A01K2267/0387 , A61K49/00 , C07K14/524 , C07K14/535 , C07K14/5403 , C07K14/7155 , C12N9/00
摘要： A mouse with a humanization of the mIL-3 gene and the mGM-CSF gene, a knockout of a mRAG gene, and a knockout of a mll2rg subunit gene; and optionally a humanization of the TPO gene is described. A RAG/ll2rg KO/hTPO knock-in mouse is described. A mouse engrafted with human hematopoietic stem cells (HSCs) that maintains a human immune cell (HIC) population derived from the HSCs and that is infectable by a human pathogen, e.g., S. typhi or M. tuberculosis is described. A mouse that models a human pathogen infection that is poorly modeled in mice is described, e.g., a mouse that models a human mycobacterial infection, wherein the mouse develops one or more granulomas comprising human immune cells. A mouse that comprises a human hematopoietic malignancy that originates from an early human hematopoietic cells is described, e.g., a myeloid leukemia or a myeloproliferative neoplasia.
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公开(公告)号：US20170112903A1
公开(公告)日：2017-04-27
申请号：US15300502
申请日：2015-03-24
CPC分类号： A61K38/196 , A61K9/1623 , A61K9/19 , A61K47/02 , A61K47/12 , A61K47/183 , A61K47/26 , C07K14/524 , C07K2317/21 , C07K2319/30
摘要： A novel and thermostable lyophilized pharmaceutical composition of Romiplostim (Fcpeptide fusion protein) along with buffer, bulking agent, stabilizer, and surfactant at pH range of 4.0-6.0.
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公开(公告)号：US09554563B2
公开(公告)日：2017-01-31
申请号：US14053182
申请日：2013-10-14
申请人： Regeneron Pharmaceuticals, Inc. , Yale University , Institute for Research in Biomedicine (IRB)
发明人： Sean Stevens , Andrew J. Murphy , Richard Flavell , Elizabeth Eynon , Jorge Galan , Tim Willinger , Markus Manz , Anthony Rongvaux , George D. Yancopoulos
IPC分类号： A01K67/00 , A01K67/027 , C07K14/52 , C07K14/535 , C07K14/54 , C07K14/715 , C12N9/00 , A61K49/00
CPC分类号： A01K67/0278 , A01K67/0271 , A01K67/0275 , A01K2207/12 , A01K2207/15 , A01K2217/072 , A01K2217/075 , A01K2217/15 , A01K2227/105 , A01K2267/03 , A01K2267/0331 , A01K2267/0337 , A01K2267/0381 , A01K2267/0387 , A61K49/00 , C07K14/524 , C07K14/535 , C07K14/5403 , C07K14/7155 , C12N9/00
摘要： A mouse with a humanization of the mIL-3 gene and the mGM-CSF gene, a knockout of a mRAG gene, and a knockout of a mIl2rg subunit gene; and optionally a humanization of the TPO gene is described. A RAG/Il2rg KO/hTPO knock-in mouse is described. A mouse engrafted with human hematopoietic stem cells (HSCs) that maintains a human immune cell (HIC) population derived from the HSCs and that is infectable by a human pathogen, e.g., S. typhi or M. tuberculosis is described. A mouse that models a human pathogen infection that is poorly modeled in mice is described, e.g., a mouse that models a human mycobacterial infection, wherein the mouse develops one or more granulomas comprising human immune cells. A mouse that comprises a human hematopoietic malignancy that originates from an early human hematopoietic cells is described, e.g., a myeloid leukemia or a myeloproliferative neoplasia.
摘要翻译： 具有mIL-3基因和mGM-CSF基因的人源化的小鼠，mRAG基因的敲除和mIl2rg亚基基因的敲除; 并且可选地描述了TPO基因的人源化。 描述了RAG / Il2rg KO / hTPO敲入小鼠。 描述了维持人类免疫细胞（HIC）群体的人类造血干细胞（HSCs）的小鼠，所述人类免疫细胞（HIC）群体来自HSC并且可被人类病原体例如伤寒沙门氏菌或结核分枝杆菌感染。 描述了模拟在小鼠中模拟不良的人类病原体感染的小鼠，例如模拟人类分枝杆菌感染的小鼠，其中小鼠产生包含人免疫细胞的一种或多种肉芽肿。 描述了包含源于早期人类造血细胞的人类造血恶性肿瘤的小鼠，例如骨髓性白血病或骨髓增生性肿瘤。
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公开(公告)号：US08999329B2
公开(公告)日：2015-04-07
申请号：US13543183
申请日：2012-07-06
IPC分类号： A61K39/395 , C07K16/28 , C07K14/52 , C07K14/715 , A61K39/00
CPC分类号： C07K16/2866 , A61K2039/505 , C07K14/524 , C07K14/715 , C07K2317/21 , C07K2317/52 , C07K2317/56 , C07K2317/72 , C07K2317/74 , Y10S424/801 , Y10S424/809
摘要： This invention provides an agonist antibody to a human thrombopoietin receptor (human c-Mpl), and pharmaceutical compositions comprising the same for use in treatment of thrombocytopenia. The disclosed agonist antibody comprises (1) antibody constant regions comprising heavy and light chain constant regions, each of which may optionally contain domain substitutions, or may contain deletions, substitutions, additions, or insertions of amino acid residues, and (2) antibody variable regions capable of binding to and activating a human thrombopoietin receptor. The-agonist antibody further induces colony formation at a concentration of 10,000 ng/ml or lower, and has a maximal activity at least 50% higher than that of PEG-rHuMGDF and an 50% effective concentration (EC50) of 100 nM or less.
摘要翻译： 本发明提供了对人类血小板生成素受体（人c-Mpl）的激动剂抗体，以及包含其用于治疗血小板减少症的药物组合物。 所公开的激动剂抗体包含（1）包含重链和轻链恒定区的抗体恒定区，每个区可任选地含有结构域取代，或可含有氨基酸残基的缺失，替换，添加或插入，和（2）抗体可变 能够结合并激活人血小板生成素受体的区域。 激动剂抗体进一步诱导浓度为10,000ng / ml或更低的集落形成，并且具有比PEG-rHuMGDF高至少50％的最大活性和100nM或更低的50％有效浓度（EC 50）。
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公开(公告)号：US08692052B2
公开(公告)日：2014-04-08
申请号：US13617472
申请日：2012-09-14
申请人： Sean Stevens , Andrew J. Murphy , Richard Flavell , Elizabeth Eynon , Jorge Galan , Tim Willinger , Markus Manz , Anthony Rongvaux , George D. Yancopoulos
发明人： Sean Stevens , Andrew J. Murphy , Richard Flavell , Elizabeth Eynon , Jorge Galan , Tim Willinger , Markus Manz , Anthony Rongvaux , George D. Yancopoulos
IPC分类号： A01K67/033 , G01N33/00
CPC分类号： A01K67/0278 , A01K67/0271 , A01K67/0275 , A01K2207/12 , A01K2207/15 , A01K2217/072 , A01K2217/075 , A01K2217/15 , A01K2227/105 , A01K2267/03 , A01K2267/0331 , A01K2267/0337 , A01K2267/0381 , A01K2267/0387 , A61K49/00 , C07K14/524 , C07K14/535 , C07K14/5403 , C07K14/7155 , C12N9/00
摘要： A mouse with a humanization of the mIL-3 gene and the mGM-CSF gene, a knockout of a mRAG gene, and a knockout of a mII2rg subunit gene; and optionally a humanization of the TPO gene is described. A RAG/II2rg KO/hTPO knock-in mouse is described. A mouse engrafted with human hematopoietic stem cells (HSCs) that maintains a human immune cell (HIC) population derived from the HSCs and that is infectable by a human pathogen, e.g., S. typhi or M. tuberculosis is described. A mouse that models a human pathogen infection that is poorly modeled in mice is described, e.g., a mouse that models a human mycobacterial infection, wherein the mouse develops one or more granulomas comprising human immune cells. A mouse that comprises a human hematopoietic malignancy that originates from an early human hematopoietic cells is described, e.g., a myeloid leukemia or a myeloproliferative neoplasia.
摘要翻译： 具有mIL-3基因和mGM-CSF基因的人源化的小鼠，mRAG基因的敲除和mII2rg亚基基因的敲除; 并且可选地描述了TPO基因的人源化。 描述了RAG / II2rg KO / hTPO敲入小鼠。 描述了维持人类免疫细胞（HIC）群体的人类造血干细胞（HSCs）的小鼠，所述人类免疫细胞（HIC）群体来自HSC并且可被人类病原体例如伤寒沙门氏菌或结核分枝杆菌感染。 描述了模拟在小鼠中模拟不良的人类病原体感染的小鼠，例如模拟人类分枝杆菌感染的小鼠，其中小鼠产生包含人免疫细胞的一种或多种肉芽肿。 描述了包含源于早期人类造血细胞的人类造血恶性肿瘤的小鼠，例如骨髓性白血病或骨髓增生性肿瘤。
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7.发明授权公开(公告)号：US08592365B2
公开(公告)日：2013-11-26
申请号：US13079615
申请日：2011-04-04
申请人： Christopher P. Holmes , David Tumelty , Qun Yin
发明人： Christopher P. Holmes , David Tumelty , Qun Yin
IPC分类号： A61K38/00
CPC分类号： C07K14/524 , A61K47/60 , C07K14/505
摘要： The present invention relates to a compound comprising a peptide moiety, a spacer moiety and a water-soluble polymer moiety such as a poly(ethylene glycol) moiety. The spacer moiety is between the peptide moiety and the water-soluble polymer moiety. The spacer moiety has the structure: —NH—(CH2)α—[O—(CH2)β]γ—Oδ—(CH2)ε—Y— wherein α, β, γ, δ, and ε are each integers whose values are independently selected.
摘要翻译： 本发明涉及包含肽部分，间隔基部分和水溶性聚合物部分如聚（乙二醇）部分的化合物。 间隔部分位于肽部分和水溶性聚合物部分之间。 间隔基部分具有以下结构：-NH-（CH 2）a - [O-（CH 2）2]γ-Odelta-（CH 2）ε-Y-，其中α，β，γ，δ和ε分别是整数， 被独立选择。
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公开(公告)号：US08399250B1
公开(公告)日：2013-03-19
申请号：US08430035
申请日：1995-04-27
CPC分类号： C07K14/524
摘要： Isolated mpl ligand, isolated DNA encoding mpl ligand, and recombinant methods of preparing mpl ligand are disclosed. These mpl ligands are shown to influence the replication, differentiation or maturation of blood cells, especially megakaryocyte progenitor cells. Accordingly, these compounds are used for treatment of thrombocytopenia.
摘要翻译： 公开了分离的mpl配体，编码mpl配体的分离的DNA和制备mpl配体的重组方法。 显示这些mpl配体影响血液细胞，特别是巨核细胞祖细胞的复制，分化或成熟。 因此，这些化合物用于治疗血小板减少症。
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公开(公告)号：US08236314B2
公开(公告)日：2012-08-07
申请号：US13232277
申请日：2011-09-14
IPC分类号： A61K39/395
CPC分类号： C07K16/2866 , A61K2039/505 , C07K14/524 , C07K14/715 , C07K2317/21 , C07K2317/52 , C07K2317/56 , C07K2317/72 , C07K2317/74 , Y10S424/801 , Y10S424/809
摘要： This invention provides an agonist antibody to a human thrombopoietin receptor (human c-Mpl), and pharmaceutical compositions comprising the same for use in treatment of thrombocytopenia. The disclosed agonist antibody comprises (1) antibody constant regions comprising heavy and light chain constant regions, each of which may optionally contain domain substitutions, or may contain deletions, substitutions, additions, or insertions of amino acid residues, and (2) antibody variable regions capable of binding to and activating a human thrombopoietin receptor. The-agonist antibody further induces colony formation at a concentration of 10,000 ng/ml or lower, and has a maximal activity at least 50% higher than that of PEG-rHuMGDF and an 50% effective concentration (EC50) of 100 nM or less.
摘要翻译： 本发明提供了对人类血小板生成素受体（人c-Mpl）的激动剂抗体，以及包含其用于治疗血小板减少症的药物组合物。 所公开的激动剂抗体包含（1）包含重链和轻链恒定区的抗体恒定区，每个区可任选地含有结构域取代，或可含有氨基酸残基的缺失，替换，添加或插入，和（2）抗体可变 能够结合并激活人血小板生成素受体的区域。 激动剂抗体进一步诱导浓度为10,000ng / ml或更低的集落形成，并且具有比PEG-rHuMGDF高至少50％的最大活性和100nM或更低的50％有效浓度（EC 50）。
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公开(公告)号：US20120053326A1
公开(公告)日：2012-03-01
申请号：US13232277
申请日：2011-09-14
IPC分类号： C07K16/28
CPC分类号： C07K16/2866 , A61K2039/505 , C07K14/524 , C07K14/715 , C07K2317/21 , C07K2317/52 , C07K2317/56 , C07K2317/72 , C07K2317/74 , Y10S424/801 , Y10S424/809
摘要： This invention provides an agonist antibody to a human thrombopoietin receptor (human c-Mpl), and pharmaceutical compositions comprising the same for use in treatment of thrombocytopenia. The disclosed agonist antibody comprises (1) antibody constant regions comprising heavy and light chain constant regions, each of which may optionally contain domain substitutions, or may contain deletions, substitutions, additions, or insertions of amino acid residues, and (2) antibody variable regions capable of binding to and activating a human thrombopoietin receptor. The-agonist antibody further induces colony formation at a concentration of 10,000 ng/ml or lower, and has a maximal activity at least 50% higher than that of PEG-rHuMGDF and an 50% effective concentration (EC50) of 100 nM or less.
摘要翻译： 本发明提供了对人类血小板生成素受体（人c-Mpl）的激动剂抗体，以及包含其用于治疗血小板减少症的药物组合物。 所公开的激动剂抗体包含（1）包含重链和轻链恒定区的抗体恒定区，每个区可任选地含有结构域取代，或可含有氨基酸残基的缺失，替换，添加或插入，和（2）抗体可变 能够结合并激活人血小板生成素受体的区域。 激动剂抗体进一步诱导浓度为10,000ng / ml或更低的集落形成，并且具有比PEG-rHuMGDF高至少50％的最大活性和100nM或更低的50％有效浓度（EC 50）。
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