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    Integrated approach for generating multidomain protein therapeutics
    3.
    发明授权
    Integrated approach for generating multidomain protein therapeutics 失效
    用于产生多结构域蛋白治疗剂的综合方法

    公开(公告)号：US08309690B2

    公开(公告)日：2012-11-13

    申请号：US11993680

    申请日：2006-06-30

    申请人： Christian Allan ,  Herren Wu ,  Jeffrey Swers ,  William Dall'Acqua

    发明人： Christian Allan ,  Herren Wu ,  Jeffrey Swers ,  William Dall'Acqua

    IPC分类号： C07K16/00

    CPC分类号： C07K16/00 ,  A61K39/39591 ,  C07K2317/52 ,  C07K2317/55

    摘要： The invention provides method for therapeutic protein drug development that incorporates therapeutic and/or formulation and/or manufacturing considerations in the early screening process. The approach involves screening a plurality of different variants of a domain that have been determined to have the desired therapeutic property to identify one or more variants that have desired therapeutic and/or formulation characteristics, and constructing the full multidomain proteins using the identified domain variants. The present invention also provides a method for determining the shelf life of multidomain proteins in formulations. The method comprises determining a thermal denaturation and/or renaturation curve of a domain of the protein whose unfolding leads to aggregation of the protein in a solution. The method evaluates the shelf life of the multidomain protein based on the denaturation/renaturation curve. The invention also provides methods for engineering multidomain proteins to improve their therapeutic and/or formulation characteristics.

    摘要翻译： 本发明提供了在早期筛选过程中结合治疗和/或制剂和/或制造考虑的治疗性蛋白质药物开发方法。 所述方法包括筛选已被确定具有所需治疗性质的结构域的多个不同变体以鉴定具有期望的治疗和/或制剂特征的一种或多种变体，以及使用鉴定的结构域变体构建完整的多结构域蛋白。 本发明还提供了一种确定制剂中多结构域蛋白质的保质期的方法。 该方法包括确定蛋白质的结构域的热变性和/或复性曲线，其解折叠导致蛋白质在溶液中聚集。 该方法基于变性/复性曲线评估多结构域蛋白质的保质期。 本发明还提供用于工程化多结构域蛋白质以改善其治疗和/或制剂特征的方法。

    INTEGRATED APPROACH FOR GENERATING MULTIDOMAIN PROTEIN THERAPEUTICS
    4.
    发明申请
    INTEGRATED APPROACH FOR GENERATING MULTIDOMAIN PROTEIN THERAPEUTICS 失效
    用于产生多种蛋白质治疗的综合方法

    公开(公告)号：US20100105873A1

    公开(公告)日：2010-04-29

    申请号：US11993680

    申请日：2006-06-30

    申请人： Christian Allan ,  Herren Wu ,  Jeffrey Swers ,  William Dall'Acqua

    发明人： Christian Allan ,  Herren Wu ,  Jeffrey Swers ,  William Dall'Acqua

    IPC分类号： C07K16/00 ,  C40B30/04

    CPC分类号： C07K16/00 ,  A61K39/39591 ,  C07K2317/52 ,  C07K2317/55

    摘要： The invention provides method for therapeutic protein drug development that incorporates therapeutic and/or formulation and/or manufacturing considerations in the early screening process. The approach involves screening a plurality of different variants of a domain that have been determined to have the desired therapeutic property to identify one or more variants that have desired therapeutic and/or formulation characteristics, and constructing the full multidomain proteins using the identified domain variants. The present invention also provides a method for determining the shelf life of multidomain proteins in formulations. The method comprises determining a thermal denaturation and/or renaturation curve of a domain of the protein whose unfolding leads to aggregation of the protein in a solution. The method evaluates the shelf life of the multidomain protein based on the denaturation/renaturation curve. The invention also provides methods for engineering multidomain proteins to improve their therapeutic and/or formulation characteristics.

    摘要翻译： 本发明提供了在早期筛选过程中结合治疗和/或制剂和/或制造考虑的治疗性蛋白质药物开发方法。 所述方法包括筛选已被确定具有所需治疗性质的结构域的多个不同变体以鉴定具有期望的治疗和/或制剂特征的一种或多种变体，以及使用鉴定的结构域变体构建完整的多结构域蛋白。 本发明还提供了一种确定制剂中多结构域蛋白质的保质期的方法。 该方法包括确定蛋白质的结构域的热变性和/或复性曲线，其解折叠导致蛋白质在溶液中聚集。 该方法基于变性/复性曲线评估多结构域蛋白质的保质期。 本发明还提供用于工程化多结构域蛋白质以改善其治疗和/或制剂特征的方法。

    Modulation Of Antibody Effector Function By Hinge Domain Engineering
    9.
    发明申请
    Modulation Of Antibody Effector Function By Hinge Domain Engineering 有权
    通过铰链域工程调制抗体效应器功能

    公开(公告)号：US20120046450A1

    公开(公告)日：2012-02-23

    申请号：US13190199

    申请日：2011-07-25

    申请人： William Dall'Acqua ,  Herren Wu ,  Melissa Damschroder ,  Jose Casas-Finet

    发明人： William Dall'Acqua ,  Herren Wu ,  Melissa Damschroder ,  Jose Casas-Finet

    IPC分类号： C07K16/18 ,  C07H21/00

    CPC分类号： C07K16/18 ,  C07K16/00 ,  C07K16/2866 ,  C07K2317/53 ,  C07K2317/71 ,  C07K2317/72 ,  C07K2317/732 ,  C07K2317/734

    摘要： The present invention relates to novel molecules (Fc variants) comprising at least one antigen binding region and an Fc region that further comprises a modified hinge which alters the binding of Fc to one or more Fc ligand (e.g., FcγRs) and/or modulates effector function. More specifically, this invention provides Fc variants that have modified binding affinity to one or more FcγR and/or C1q. Additionally, the Fc variants have altered antibody-dependent cell-mediated cytotoxicity (ADCC) and/or complement dependent cytotoxicity (CDC) activity. The invention further provides methods and protocols for the application of said Fc variants particularly for therapeutic purposes.

    摘要翻译： 本发明涉及包含至少一个抗原结合区和Fc区的新分子（Fc变体），其还包含修饰的铰链，其改变Fc与一个或多个Fc配体（例如FcγR）的结合和/或调节效应子 功能。 更具体地，本发明提供了对一种或多种FcγR和/或C1q具有修饰的结合亲和力的Fc变体。 另外，Fc变体具有改变的抗体依赖性细胞介导的细胞毒性（ADCC）和/或补体依赖性细胞毒性（CDC）活性。 本发明还提供了用于所述Fc变体的应用的方法和方案，特别是用于治疗目的。

    METHODS OF ADMINISTERING/DOSING ANTI-RSV ANTIBODIES FOR PROPHYLAXIS AND TREATMENT
    10.
    发明申请
    METHODS OF ADMINISTERING/DOSING ANTI-RSV ANTIBODIES FOR PROPHYLAXIS AND TREATMENT 失效
    用于预防和治疗的抗RSV抗体的方法

    公开(公告)号：US20100028948A1

    公开(公告)日：2010-02-04

    申请号：US12476183

    申请日：2009-06-01

    申请人： James F. Young ,  Scott Koenig ,  Leslie S. Johnson ,  William D. Huse ,  Jeffrey D. Watkins ,  Herren Wu

    发明人： James F. Young ,  Scott Koenig ,  Leslie S. Johnson ,  William D. Huse ,  Jeffrey D. Watkins ,  Herren Wu

    IPC分类号： C12P21/00 ,  C07H21/00 ,  C12N15/63 ,  C12N5/00

    CPC分类号： C07K16/1027 ,  A61K2039/505 ,  C07K2317/24 ,  C07K2317/56 ,  C07K2317/565

    摘要： The present invention encompasses novel antibodies and fragments thereof which immunospecifically bind to one or more RSV antigens and compositions comprising said antibodies and antibody fragments. The present invention encompasses methods preventing respiratory syncytial virus (RSV) infection in a human, comprising administering to said human a prophylactically effective amount of one or more antibodies or fragments thereof that immunospecifically bind to one or more RSV antigens, wherein a certain serum titer of said antibodies or antibody fragments is achieved in said human subject. The present invention also encompasses methods for treating or ameliorating symptoms associated with a RSV infection in a human, comprising administering to said human a therapeutically effective amount of one or more antibodies or fragments thereof that immunospecifically bind to one or more RSV antigens, wherein a certain serum titer of said antibodies or antibody fragments is achieved in said human subject. The present invention further encompasses compositions comprising antibodies or fragments thereof that immunospecifically bind to a RSV antigen, and methods using said compositions for detection or diagnosis a RSV infection.

    摘要翻译： 本发明包括免疫特异性结合一种或多种RSV抗原的新型抗体及其片段，以及包含所述抗体和抗体片段的组合物。 本发明包括预防人类呼吸道合胞病毒（RSV）感染的方法，包括向所述人施用预防有效量的一种或多种免疫特异性结合一种或多种RSV抗原的抗体或其片段，其中一定的血清滴度为 所述抗体或抗体片段在所述人受试者中实现。 本发明还包括用于治疗或改善与人类RSV感染有关的症状的方法，包括向所述人施用治疗有效量的一种或多种免疫特异性结合一种或多种RSV抗原的抗体或其片段，其中一定 所述抗体或抗体片段的血清滴度在所述人受试者中实现。 本发明还包括包含免疫特异性结合RSV抗原的抗体或其片段的组合物，以及使用所述组合物检测或诊断RSV感染的方法。