公开(公告)号：US20130323247A1

公开(公告)日：2013-12-05

申请号：US13127541

申请日：2009-11-06

申请人： Gerhard Zugmaier ,  Evelyn Degenhard

发明人： Gerhard Zugmaier ,  Evelyn Degenhard

IPC分类号： A61K39/395 ,  C07K16/46 ,  A61P35/02

CPC分类号： C07K16/2809 ,  C07K16/2803 ,  C07K16/468

摘要： The present invention relates to a method for the treatment, amelioration or elimination of acute lymphoblastic leukemia (ALL), the method comprising the administration of a pharmaceutical composition comprising a CD19xCD3 bispecific single chain antibody construct to an adult patient in the need thereof.

摘要翻译： 本发明涉及一种治疗，改善或消除急性淋巴细胞白血病（ALL）的方法，所述方法包括向需要的成年患者施用包含CD19xCD3双特异性单链抗体构建体的药物组合物。

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。

公开(公告)号：US20120009204A1

公开(公告)日：2012-01-12

申请号：US13180093

申请日：2011-07-11

申请人： Carsten Reinhardt ,  Robert Saller

发明人： Carsten Reinhardt ,  Robert Saller

IPC分类号： A61K39/395 ,  A61P35/04

CPC分类号： A61K39/39558 ,  A61K2039/505 ,  C07K16/30

摘要： The present invention relates to the use of an anti-EpCAM antibody for the manufacture of a medicament for the treatment of metastatic breast cancer. The present invention further relates to a method of treating metastatic breast cancer comprising administering said anti-EpCAM antibody.

摘要翻译： 本发明涉及抗EpCAM抗体在制备用于治疗转移性乳腺癌的药物中的用途。 本发明还涉及治疗转移性乳腺癌的方法，其包括施用所述抗EpCAM抗体。

公开(公告)号：US08017748B2

公开(公告)日：2011-09-13

申请号：US11918368

申请日：2006-04-18

申请人： Tobias Raum ,  Julia Hepp (Nee Henckel) ,  Eva Vieser (Nee Krinner) ,  Silke Petsch (Nee Mittelstrass) ,  Steven Zeman ,  Andreas Wolf ,  Sandra Bruckmaier

发明人： Tobias Raum ,  Julia Hepp (Nee Henckel) ,  Eva Vieser (Nee Krinner) ,  Silke Petsch (Nee Mittelstrass) ,  Steven Zeman ,  Andreas Wolf ,  Sandra Bruckmaier

IPC分类号： C07H21/04 ,  C07K16/22 ,  C12P21/08 ,  A61K38/18

CPC分类号： C07K16/243 ,  A61K2039/505 ,  C07K2317/21 ,  C07K2317/24 ,  C07K2317/33 ,  C07K2317/34 ,  C07K2317/56 ,  C07K2317/565 ,  C07K2317/622 ,  C07K2317/73 ,  C07K2317/76 ,  C07K2317/92

摘要： The present invention relates to a human monoclonal antibody or fragment thereof which specifically binds to and neutralizes primate GM-CSF.

摘要翻译： 本发明涉及特异性结合并中和灵长类动物GM-CSF的人单克隆抗体或其片段。

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。

公开(公告)号：US07632925B2

公开(公告)日：2009-12-15

申请号：US11860242

申请日：2007-09-24

申请人： Peter Kufer ,  Tobias Raum

发明人： Peter Kufer ,  Tobias Raum

IPC分类号： C12P21/08 ,  C07K16/00 ,  A61K39/395 ,  C12P21/04 ,  C07H21/04

CPC分类号： C07K16/30 ,  A61K38/00 ,  C07K16/00 ,  C07K2317/34

摘要： The present invention provides an anti-human antibody or fragment thereof that is low or not immunogenic in humans. In particular, the antibodies or fragments are directed to human tumor antigens, preferably to the human tumor antigen 17-1A, also known as EpCAM, EGP or GA 733-2. Also provided are pharmaceutical compositions comprising the aforementioned antibodies or fragments thereto.

摘要翻译： 本发明提供在人体中低或不是免疫原性的抗人抗体或其片段。 特别地，抗体或片段针对人肿瘤抗原，优选针对人肿瘤抗原17-1A，也称为EpCAM，EGP或GA 733-2。 还提供了包含上述抗体或其片段的药物组合物。

公开(公告)号：US20090252683A1

公开(公告)日：2009-10-08

申请号：US12083351

申请日：2006-10-10

申请人： Roman Kischel ,  Tobias Raum ,  Bernd Schlereth ,  Doris Rau ,  Ronny Cierpka ,  Peter Kufer

发明人： Roman Kischel ,  Tobias Raum ,  Bernd Schlereth ,  Doris Rau ,  Ronny Cierpka ,  Peter Kufer

IPC分类号： A61K39/395 ,  C07K16/18 ,  C12N15/13 ,  C12N15/85 ,  C12N5/16 ,  C12P21/02 ,  A61P35/00 ,  A61B10/00

CPC分类号： A61K39/39558 ,  A61K45/06 ,  A61K2039/505 ,  C07K16/2809 ,  C07K16/30 ,  C07K16/40 ,  C07K16/468 ,  C07K2317/31 ,  C07K2317/34 ,  C07K2317/56 ,  C07K2317/622

摘要： The present invention relates to uses of bispecific antibodies exhibiting cross-species specificity for evaluating the in vivo safety and/or activity and/or pharmacokinetic profile of the same in non-human species and humans. The present invention moreover relates to methods for evaluating the in vivo safety and/or activity and/or pharmacokinetic profile of said bispecific anti-bodies exhibiting cross-species specificity. The present invention also relates to methods of measuring the biological activity and/or efficacy of such bispecific antibodies exhibiting cross-species specificity. In addition, the present invention relates to pharmaceutical compositions comprising bispecific single chain antibodies exhibiting cross-species specificity and to methods for the preparation of pharmaceutical compositions comprising said bispecific single chain antibodies exhibiting cross-species specificity for the treatment of diseases.

摘要翻译： 本发明涉及显示跨物种特异性的双特异性抗体用于评估其在非人物种和人中的体内安全性和/或其活性和/或药代动力学特征的用途。 本发明还涉及用于评估展示跨物种特异性的所述双特异性抗体的体内安全性和/或活性和/或药代动力学特征的方法。 本发明还涉及测量显示跨物种特异性的这种双特异性抗体的生物活性和/或功效的方法。 此外，本发明涉及包含显示跨物种特异性的双特异性单链抗体的药物组合物和用于制备药物组合物的方法，所述药物组合物包含显示针对疾病治疗疾病的跨物种特异性的所述双特异性单链抗体。

公开(公告)号：US20090241202A1

公开(公告)日：2009-09-24

申请号：US12095822

申请日：2006-12-14

申请人： Peter Kufer ,  Tobias Raum ,  Petra Lutterbüse ,  Bernd Schlereth ,  Klaus Brischwein ,  Robert Hofmeister

发明人： Peter Kufer ,  Tobias Raum ,  Petra Lutterbüse ,  Bernd Schlereth ,  Klaus Brischwein ,  Robert Hofmeister

IPC分类号： A61K49/00 ,  C07K16/00 ,  C12N15/63 ,  C12N5/00 ,  C12P21/00

CPC分类号： C07K16/30 ,  A61K2039/505 ,  C07K16/462 ,  C07K2317/732

摘要： The present invention relates to antibodies. Specifically, the present invention relates to antibodies composed of novel combinations of inter-species antibody domains (“domain-grafted antibodies”). The present invention further relates to compositions comprising such domain-grafted antibodies, as well as methods for producing such domain-grafted antibodies. Finally, the present invention relates to methods of evaluating the in vivo biological effect of such domain-grafted antibodies as well as uses of such domain-grafted antibodies for cross-species evaluation of the in vivo activity antibodies intended for human therapy.

摘要翻译： 本发明涉及抗体。 具体地，本发明涉及由物种间抗体结构域（“结构域接枝抗体”）的新型组合构成的抗体。 本发明还涉及包含这种结构域接枝抗体的组合物，以及生产这种结构域接枝抗体的方法。 最后，本发明涉及评价这种结构域接枝抗体的体内生物学效应的方法以及这种结构域接枝抗体用于物种评价用于人类治疗的体内活性抗体的用途。

公开(公告)号：US20070122852A1

公开(公告)日：2007-05-31

申请号：US10534788

申请日：2003-11-12

申请人： Patrick Bauerle ,  Patrick Hoffman ,  Susanne Weinberger ,  Roman Kischel

发明人： Patrick Bauerle ,  Patrick Hoffman ,  Susanne Weinberger ,  Roman Kischel

IPC分类号： C40B30/06 ,  C40B50/06 ,  C40B40/10 ,  G01N33/567 ,  C07K16/28

CPC分类号： C07K16/2818 ,  C07K16/4283 ,  C07K2317/31 ,  C07K2317/622 ,  G01N15/1456 ,  G01N33/542 ,  G01N33/56972 ,  G01N2015/149

摘要： The present invention relates to a method of identifying a B cell carrying a surface immunoglobulin molecule having a binding site for an antigen of interest comprising contacting a sample putatively containing said B cell with the antigen of interest wherein said antigen is labeled with a first label and with a receptor specifically binding to said surface immunoglobulin molecule wherein said receptor is labeled with a second label and wherein said first label, when being brought into a spatial proximity of between 10 and 100 Angstrom with said second label emits a detectable signal upon activation of said second label by an external source and assessing the presence of said detectable signal, wherein said presence is, in turn, indicative of the B cell carrying a surface molecule having a binding site for the antigen of interest.

摘要翻译： 本发明涉及一种鉴定携带具有感兴趣的抗原结合位点的表面免疫球蛋白分子的B细胞的方法，包括将所述B细胞的推定含有的样品与感兴趣的抗原接触，其中所述抗原用第一标记标记， 具有特异性结合所述表面免疫球蛋白分子的受体，其中所述受体用第二标记物标记，并且其中所述第一标记在被所述第二标记物置于10埃至100埃之间的空间接近度时，在激活所述第二标记时发射可检测信号 第二标记，并评估所述可检测信号的存在，其中所述存在反过来指示携带具有感兴趣抗原结合位点的表面分子的B细胞。

公开(公告)号：US08394926B2

公开(公告)日：2013-03-12

申请号：US12158611

申请日：2006-12-21

申请人： Ralf Lutterbüse ,  Petra Mayer ,  Evelyne Schaller ,  Doris Rau ,  Susanne Mangold ,  Peter Kufer ,  Alexander Murr ,  Tobias Raum ,  Monika Wissinger

发明人： Ralf Lutterbüse ,  Petra Mayer ,  Evelyne Schaller ,  Doris Rau ,  Susanne Mangold ,  Peter Kufer ,  Alexander Murr ,  Tobias Raum ,  Monika Wissinger

IPC分类号： C12P21/08

CPC分类号： C07K16/468 ,  A61K39/39558 ,  A61K45/06 ,  C07K16/2809 ,  C07K16/3007 ,  C07K16/46 ,  C07K2317/21 ,  C07K2317/31 ,  C07K2317/565 ,  C07K2319/00

摘要： The present disclosure relates to a bispecific single chain antibody which has a first binding domain specifically binding to human CD3, and a second binding domain specifically binding to human CEA, where the second binding domain comprises at least a part of the CDR-H3 or the complete CDR-H3 of murine monoclonal antibody A5B7, a pharmaceutical composition comprising the bispecific single chain antibody, and methods for the treatment of an epithelial tumor in a human with the pharmaceutical compositions containing the bispecific single chain antibody. Furthermore, processes for the production of the pharmaceutical compositions as well as medical/pharmaceutical uses for the specific bispecific single chain antibody molecules bearing specificities for the human CD3 antigen and the human CEA antigen are disclosed.

摘要翻译： 本公开内容涉及具有特异性结合人CD3的第一结合结构域和特异性结合人CEA的第二结合结构域的双特异性单链抗体，其中第二结合结构域包含至少一部分CDR-H3或 含有双特异性单链抗体的单克隆抗体A5B7的完整CDR-H3，包含双特异性单链抗体的药物组合物，以及用含有双特异性单链抗体的药物组合物治疗人的上皮肿瘤的方法。 此外，公开了用于生产药物组合物的方法以及具有对人CD3抗原和人CEA抗原具有特异性的特异性双特异性单链抗体分子的医学/药物用途。