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    DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY
    1.
    发明申请
    DOSAGE REGIMEN FOR ADMINISTERING A CD19XCD3 BISPECIFIC ANTIBODY 有权
    用于管理CD19XCD3双相抗体的剂量计

    公开(公告)号：US20120328618A1

    公开(公告)日：2012-12-27

    申请号：US13504665

    申请日：2010-10-27

    申请人： Dirk Nagorsen ,  Peter Kufer ,  Gerbach Zugmaier ,  Patrick Baeuerle

    发明人： Dirk Nagorsen ,  Peter Kufer ,  Gerbach Zugmaier ,  Patrick Baeuerle

    IPC分类号： A61K39/395 ,  A61P35/02 ,  A61P35/00

    CPC分类号： C07K16/2809 ,  A61K2039/505 ,  A61K2039/545 ,  A61K2039/55 ,  C07K16/2803 ,  C07K2317/31 ,  G01N33/505 ,  G01N33/5052 ,  G01N33/5094 ,  G01N2800/52

    摘要： The present invention relates to a method for assessing (analyzing) the risk of potential adverse effects for a human patient mediated by the administration of a CD19×CD3 bispecific antibody to said patient comprising determining the ratio of B cells to T cells of said patient, wherein a ratio of about 1:5 or lower is indicative for a risk of potential adverse effects for said patient. Accordingly, the present invention relates a method (dosage regimen) for administering a CD19×CD3 bispecific antibody to a human patient having a B:T cell ratio of about 1:5 or lower, comprising (a) administering a first dose of said antibody for a first period of time; and consecutively (b) administering a second dose of said antibody for a second period of time, wherein said second dose exceeds said first dose.In some embodiments, a third dose of said antibody is administered for a third period of time. This dosage regimen can be applied in methods for treating malignant CD19 positive lymphocytes or for ameliorating and/or preventing an adverse effect mediated by the administration of said bispecific antibody. The present invention also relates to the use of a CD19×CD3 bispecific antibody for the preparation of a pharmaceutical composition to be used in a method of the present invention. A pharmaceutical package or kit comprising a first dose and a second dose and optionally a third dose of said antibody as defined in the methods/dosage regimen of the present invention is disclosed as well.

    摘要翻译： 本发明涉及用于评估（分析）通过向所述患者施用CD19×CD3双特异性抗体介导的人类患者的潜在不良反应的风险的方法，包括确定所述患者的B细胞与T细胞的比率， 其中约1:5或更低的比率指示对所述患者具有潜在不利影响的风险。 因此，本发明涉及用于向B：T细胞比例为约1:5或更低的人类患者施用CD19×CD3双特异性抗体的方法（剂量方案），其包括（a）施用第一剂量的所述抗体 第一段时间; 并且连续地（b）在第二时间段内施用第二剂量的所述抗体，其中所述第二剂量超过所述第一剂量。在一些实施方案中，所述抗体的第三剂量施用第三时间段。 该给药方案可以用于治疗恶性CD19阳性淋巴细胞的方法或用于改善和/或预防由所述双特异性抗体施用介导的不良作用。 本发明还涉及CD19×CD3双特异性抗体用于制备用于本发明方法的药物组合物的用途。 还公开了包含本发明的方法/剂量方案中定义的第一剂量和第二剂量以及任选地第三剂量的所述抗体的药物包装或试剂盒。

    MEANS AND METHODS FOR THE TREATMENT OF TUMOROUS DISEASES
    3.
    发明申请
    MEANS AND METHODS FOR THE TREATMENT OF TUMOROUS DISEASES 有权
    治疗肿瘤疾病的手段和方法

    公开(公告)号：US20090291072A1

    公开(公告)日：2009-11-26

    申请号：US12095951

    申请日：2006-11-29

    申请人： Patrick Baeuerle ,  Peter Kufer ,  Matthias Klinger ,  Eugen Leo

    发明人： Patrick Baeuerle ,  Peter Kufer ,  Matthias Klinger ,  Eugen Leo

    IPC分类号： A61K39/395

    CPC分类号： A61K39/39558 ,  A61K45/06 ,  A61K2039/505 ,  C07K16/2803 ,  C07K16/2809 ,  C07K2317/31

    摘要： Provided are pharmaceutical means and methods for the prevention, treatment or amelioration of indolent or aggressive B cell non-Hodgkin lymphoma (B NHL) and B cell leukemia comprising the administration of a bispecific single chain antibody construct to a subject in the need thereof and the use of said bispecific single chain antibody construct for the preparation of a pharmaceutical composition for the prevention, treatment or amelioration of indolent or aggressive B cell non-Hodgkin lymphoma (B NHL) and B cell leukemia, whereby said construct is to be administered for at least 1 week in specified daily doses. Moreover, the invention relates to kits comprising a bispecific single chain antibody construct to be used in accordance with this invention.

    摘要翻译： 提供了用于预防，治疗或改善无痛或侵袭性B细胞非霍奇金淋巴瘤（B NHL）和B细胞白血病的药物方法和方法，其包括在需要时向受试者施用双特异性单链抗体构建体， 使用所述双特异性单链抗体构建体来制备用于预防，治疗或改善无痛或侵袭性B细胞非霍奇金淋巴瘤（B NHL）和B细胞白血病的药物组合物，其中所述构建体将被施用于 至少1周，指定日剂量。 此外，本发明涉及包含根据本发明使用的双特异性单链抗体构建体的试剂盒。

    Means and methods for the treatment of tumorous diseases
    4.
    发明授权
    Means and methods for the treatment of tumorous diseases 有权
    治疗肿瘤疾病的手段和方法

    公开(公告)号：US08007796B2

    公开(公告)日：2011-08-30

    申请号：US12095951

    申请日：2006-11-29

    申请人： Patrick Baeuerle ,  Peter Kufer ,  Matthias Klinger ,  Eugen Leo

    发明人： Patrick Baeuerle ,  Peter Kufer ,  Matthias Klinger ,  Eugen Leo

    IPC分类号： A61K39/00 ,  A61K39/935

    CPC分类号： A61K39/39558 ,  A61K45/06 ,  A61K2039/505 ,  C07K16/2803 ,  C07K16/2809 ,  C07K2317/31

    摘要： The invention relates to pharmaceutical means and methods for the prevention, treatment or amelioration of indolent or aggressive B cell non-Hodgkin lymphoma (B NHL) and B cell leukemia comprising the administration of a bispecific single chain antibody construct to a subject and the use of the bispecific single chain antibody construct for the preparation of a pharmaceutical composition for the prevention, treatment or amelioration of indolent or aggressive B cell non-Hodgkin lymphoma (B NHL) and B cell leukemia. The construct is to be administered for at least 1 week in specified daily doses. Moreover, the invention relates to kits comprising a bispecific single chain antibody construct to be used in accordance with this invention.

    摘要翻译： 本发明涉及用于预防，治疗或改善无痛或侵袭性B细胞非霍奇金淋巴瘤（B NHL）和B细胞白血病的药物方法和方法，其包括向受试者施用双特异性单链抗体构建体，以及使用 用于制备用于预防，治疗或改善无痛或侵袭性B细胞非霍奇金淋巴瘤（B NHL）和B细胞白血病的药物组合物的双特异性单链抗体构建体。 该构建体以规定的日剂量施用至少1周。 此外，本发明涉及包含根据本发明使用的双特异性单链抗体构建体的试剂盒。

    BISPECIFIC ANTIBODIES
    7.
    发明申请
    BISPECIFIC ANTIBODIES 审中-公开
    双重抗体

    公开(公告)号：US20080305105A1

    公开(公告)日：2008-12-11

    申请号：US11754792

    申请日：2007-05-29

    申请人： Peter Kufer ,  Meera Berry ,  Patrick Baeuerle ,  Christian Itin

    发明人： Peter Kufer ,  Meera Berry ,  Patrick Baeuerle ,  Christian Itin

    IPC分类号： A61K39/395 ,  C07K16/18 ,  A61P31/00

    摘要： The present invention discloses bispecific antibodies comprising two antibody variable domains on a single polypeptide chain, wherein a first portion of the bispecific antibody is capable of recruiting the activity of a human immune effector cell by specifically binding to an effector antigen on the human immune effector cell, the first portion consisting of one antibody variable domain, and a second portion of the bispecific antibody specifically binding to a target antigen other than the effector antigen, the target antigen on a target cell other than the human immune effector cell, the second portion comprising one antibody variable domain.

    摘要翻译： 本发明公开了在单个多肽链上包含两个抗体可变结构域的双特异性抗体，其中双特异性抗体的第一部分能够通过特异性结合人免疫效应细胞上的效应物抗原募集人免疫效应细胞的活性 ，第一部分由一个抗体可变结构域组成，第二部分特异性结合除效应物抗原之外的靶抗原的双特异性抗体，除人免疫效应细胞以外的靶细胞上的靶抗原，第二部分包含 一个抗体可变结构域。

    EphA2 BiTE molecules and uses thereof
    8.
    发明申请
    EphA2 BiTE molecules and uses thereof 审中-公开
    EphA2 BiTE分子及其用途

    公开(公告)号：US20080044413A1

    公开(公告)日：2008-02-21

    申请号：US11645290

    申请日：2006-12-21

    申请人： Scott Hammond ,  Peter Kiener ,  Elizabeth Bruckheimer ,  Michael Kinch ,  Shannon Roff ,  Ralf Lutterbuese ,  Petra Lutterbuese ,  Bernd Schlereth ,  Patrick Baeuerle ,  Peter Kufer

    发明人： Scott Hammond ,  Peter Kiener ,  Elizabeth Bruckheimer ,  Michael Kinch ,  Shannon Roff ,  Ralf Lutterbuese ,  Petra Lutterbuese ,  Bernd Schlereth ,  Patrick Baeuerle ,  Peter Kufer

    IPC分类号： A61K39/395 ,  A61P31/00 ,  A61P35/00 ,  A61P43/00 ,  C07K16/28

    CPC分类号： C07K16/2866 ,  C07K16/2809 ,  C07K16/30 ,  C07K2317/24 ,  C07K2317/31 ,  C07K2317/56 ,  C07K2317/565 ,  C07K2317/567 ,  C07K2317/92 ,  C07K2319/30

    摘要： The present invention relates to bispecific single chain antibodies comprising a first binding domain that immunospecifically binds to the T-cell antigen CD3 and a second binding domain that immunospecifically binds to the EphA2 receptor. Such bispecific single chain antibodies are encompassed by the term “EphA2-BiTEs.” The present invention further relates to methods and compositions designed for the treatment, prevention and/or management of disorders associated with aberrant expression and/or activity of EphA2. Such disorders include, but are not limited to, cancer, non-cancer hyperproliferative cell disorders, and infections. The invention further relates to vectors comprising polynucleotides encoding the EphA2-BiTEs of the invention, host cells transformed therewith, and their use in the production of said EphA2-BiTEs. The invention also provides compositions, including pharmaceutical compositions, comprising any of the aforementioned EphA2-BiTEs, polynucleotides or vectors either alone or in combination with one or more prophylactic or therapeutic agents. Also disclosed are methods of screening for said EphA2-BiTEs and kits comprising any of the aforementioned compositions and diagnostic reagents.

    摘要翻译： 本发明涉及双特异性单链抗体，其包含免疫特异性结合T细胞抗原CD3的第一结合结构域和免疫特异性结合EphA2受体的第二结合结构域。 这种双特异性单链抗体包括在术语“EphA2-BiTEs”中。 本发明还涉及设计用于治疗，预防和/或控制与EphA2的异常表达和/或活性相关的病症的方法和组合物。 这些疾病包括但不限于癌症，非癌症过度增殖性细胞病症和感染。 本发明还涉及包含编码本发明的EphA2-BiTE的多核苷酸，转化的宿主细胞的载体及其在所述EphA2-BiTE的生产中的用途。 本发明还提供包含单独或与一种或多种预防或治疗剂组合的任何上述EphA2-BiTE，多核苷酸或载体的组合物，包括药物组合物。 还公开了筛选所述EphA2-BiTE和包含任何上述组合物和诊断试剂的试剂盒的方法。

    MEANS AND METHODS FOR THE TREAMENT OF TUMOROUS DISEASES
    10.
    发明申请
    MEANS AND METHODS FOR THE TREAMENT OF TUMOROUS DISEASES 审中-公开
    肿瘤疾病的手段和方法

    公开(公告)号：US20130095103A1

    公开(公告)日：2013-04-18

    申请号：US13219120

    申请日：2011-08-26

    申请人： Patrick Baeuerle ,  Peter Kufer ,  Matthias Klinger ,  Eugen Leo

    发明人： Patrick Baeuerle ,  Peter Kufer ,  Matthias Klinger ,  Eugen Leo

    IPC分类号： A61K39/395 ,  A61K45/06

    CPC分类号： A61K39/39558 ,  A61K45/06 ,  A61K2039/505 ,  C07K16/2803 ,  C07K16/2809 ,  C07K2317/31

    摘要： Provided are pharmaceutical means and methods for the prevention, treatment or amelioration of indolent or aggressive B cell non-Hodgkin lymphoma (B NHL) and B cell leukemia comprising the administration of a bispecific single chain antibody construct to a subject in the need thereof and the use of said bispecific single chain antibody construct for the preparation of a pharmaceutical composition for the prevention, treatment or amelioration of indolent or aggressive B cell non-Hodgkin lymphoma (B NHL) and B cell leukemia, whereby said construct is to be administered for at least 1 week in specified daily doses. Moreover, the invention relates to kits comprising a bispecific single chain antibody construct to be used in accordance with this invention.

    摘要翻译： 提供了用于预防，治疗或改善无痛或侵袭性B细胞非霍奇金淋巴瘤（B NHL）和B细胞白血病的药物方法和方法，其包括在需要时向受试者施用双特异性单链抗体构建体， 使用所述双特异性单链抗体构建体来制备用于预防，治疗或改善无痛或侵袭性B细胞非霍奇金淋巴瘤（B NHL）和B细胞白血病的药物组合物，其中所述构建体将被施用于 至少1周，指定日剂量。 此外，本发明涉及包含根据本发明使用的双特异性单链抗体构建体的试剂盒。