公开(公告)号：EP3408295A1

公开(公告)日：2018-12-05

申请号：EP17702801.6

申请日：2017-01-25

申请人： Amgen Research (Munich) GmbH ,  Amgen Inc.

发明人： KANAPURAM, Sekhar ,  LATYPOV, Ramil ,  THANGARAJ, Balakumar ,  POMPE, Cornelius

IPC分类号： C07K16/28 ,  A61K39/395 ,  A61K47/00

CPC分类号： A61K39/3955 ,  A61K9/0019 ,  A61K9/1652 ,  A61K9/19 ,  A61K47/02 ,  A61K47/10 ,  A61K47/12 ,  A61K47/183 ,  A61K47/26 ,  A61K47/40 ,  A61K2039/505 ,  B01D61/145 ,  B01D2315/16 ,  C07K16/2803 ,  C07K16/2809 ,  C07K16/2878 ,  C07K2317/24 ,  C07K2317/31 ,  C07K2317/622 ,  C07K2317/94

摘要： The present invention provides novel and stable pharmaceutical compositions comprising bispecific single chain antibody constructs, cyclodextrins and a buffer.

公开(公告)号：EP3328889A1

公开(公告)日：2018-06-06

申请号：EP16756950.8

申请日：2016-08-01

申请人： Amgen Research (Munich) GmbH

发明人： RAUM, Tobias ,  KUFER, Peter ,  PENDZIALEK, Jochen ,  BLUEMEL, Claudia ,  DAHLHOFF, Christoph ,  HOFFMANN, Patrick ,  LUTTERBUESE, Ralf ,  NAHRWOLD, Elisabeth

IPC分类号： C07K16/28

CPC分类号： C07K16/2809 ,  A61K2039/505 ,  C07K16/18 ,  C07K16/28 ,  C07K2317/31 ,  C07K2317/33 ,  C07K2317/34 ,  C07K2317/622 ,  C07K2317/73 ,  C07K2317/77 ,  C07K2317/92 ,  C07K2317/94

摘要： The present invention relates to a bispecific antibody construct comprising a first binding domain which binds to human DLL3 on the surface of a target cell and a second binding domain which binds to human CD3 on the surface of a T cell. Moreover, the invention provides a polynucleotide encoding the antibody construct, a vector comprising said polynucleotide and a host cell transformed or transfected with said polynucleotide or vector. Furthermore, the invention provides a process for the production of the antibody construct of the invention, a medical use of said antibody construct and a kit comprising said antibody construct.

公开(公告)号：EP2820047B1

公开(公告)日：2018-04-25

申请号：EP13716734.2

申请日：2013-03-01

申请人： Amgen Research (Munich) GmbH

发明人： KUFER, Peter ,  RAUM, Tobias ,  LUTTERBUESE, Ralf ,  HOFFMANN, Patrick ,  MUENZ, Markus ,  BROZY, Johannes ,  KVESIC, Majk

IPC分类号： C07K16/28

CPC分类号： C07K16/2809 ,  C07K16/26 ,  C07K16/30 ,  C07K16/3069 ,  C07K2317/31 ,  C07K2317/34 ,  C07K2317/569 ,  C07K2317/622 ,  C07K2317/732 ,  C07K2317/92 ,  C07K2319/30 ,  C07K2319/31 ,  C07K2319/32

摘要： The present invention relates to a binding molecule comprising at least three domains comprised in at least one polypeptide chain, wherein the first binding domain is a binding domain which is capable of binding to a cell surface molecule on a target cell, the second binding domain is a binding domain which is capable of binding to the T cell CD3 receptor complex, and the third domain is a binding domain which is capable of binding to serum albumin, wherein said third domain is positioned at the C-terminus of said second domain. Moreover, the invention provides a nucleic acid sequence encoding the binding molecule, a vector comprising said nucleic acid sequence and a host cell transformed or transfected with said vector. Furthermore, the invention provides a process for the production of the binding molecule of the invention, a medical use of said binding molecule and a kit comprising said binding molecule.

公开(公告)号：EP3178850A1

公开(公告)日：2017-06-14

申请号：EP16200832.0

申请日：2006-10-10

申请人： Amgen Research (Munich) GmbH

发明人： KISCHEL, Roman ,  RAUM, Tobias ,  SCHLERETH, Bernd ,  RAU, Doris ,  BRÜNSCH, Ronny ,  KUFER, Peter

IPC分类号： C07K16/28 ,  C07K16/30 ,  A61K39/395 ,  A61P35/00 ,  C12N15/13

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 antibodies 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非人类物种和人类的体内安全性和/或活性和/或其药代动力学特征的用途。 本发明还涉及用于评估表现出种间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。 本发明还涉及测量表现出种间特异性的此类双特异性抗体的生物活性和/或功效的方法。 另外，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，以及涉及用于制备药物组合物的方法，所述药物组合物包含表现出用于治疗疾病的种间特异性的所述双特异性单链抗体。

公开(公告)号：EP1976880B1

公开(公告)日：2016-07-06

申请号：EP06841112.3

申请日：2006-12-21

申请人： Amgen Research (Munich) GmbH

发明人： LUTTERBÜSE, Ralf ,  MAYER, Petra ,  SCHALLER, Evelyne ,  RAU, Doris ,  MANGOLD, Susanne ,  KUFER, Peter ,  MURR, Alexander ,  WISSINGER, Monika ,  RAUM, Tobias

IPC分类号： C07K16/24 ,  C07K16/30 ,  A61K39/395

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 invention relates to pharmaceutical compositions for the treatment of an epithelial tumor in a human, said pharmaceutical composition comprising 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, wherein said second binding domain comprises at least a part of the CDR-H3 or the complete CDR-H3 of murine monoclonal antibody A5B7. Furthermore, processes for the production of said 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： 本发明涉及用于治疗人类上皮肿瘤的药物组合物，所述药物组合物包含具有特异性结合人CD3的第一结合结构域的双特异性单链抗体和与人CEA特异性结合的第二结合结构域， 其中所述第二结合结构域包含鼠单克隆抗体A5B7的CDR-H3或完整CDR-H3的至少一部分。 此外，公开了用于生产所述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。

公开(公告)号：EP3018145A1

公开(公告)日：2016-05-11

申请号：EP15195076.3

申请日：2011-10-27

申请人： Amgen Research (Munich) GmbH

发明人： ZUGMAIER, Gerhard ,  NAGORSEN, Dirk ,  SCHEELE, Juergen

IPC分类号： C07K16/28 ,  C07K16/46 ,  A61K39/395 ,  A61P35/00

CPC分类号： C07K16/2809 ,  A61K39/39558 ,  A61K2039/505 ,  A61K2039/545 ,  C07K16/2803 ,  C07K2317/31 ,  C07K2317/76

摘要： The present invention provides means and methods for treating diffuse large B cell lymphoma (DLBCL). Specifically, a bispecific CD19 x CD3 antibody which engages T cells via its CD3 binding portion and concomitantly binds to CD19 on the surface of, in particular, lymphoma cells via its CD19 binding portion (i.e. a bispecific T cell engager, "BiTE") is administered for use in the treatment of tumorous mass of lymophoreticular tissue and/or extranodal lymphoma caused by DLBCL in a patient.

摘要翻译： 本发明提供治疗弥漫性大B细胞淋巴瘤（DLBCL）的方法和方法。 具体地，通过其CD3结合部分与T细胞接合并通过其CD19结合部分（即，双特异性T细胞募集体“BiTE”）同时结合特异性淋巴瘤细胞表面上的CD19的双特异性CD19×CD3抗体是 用于治疗由患者DLBCL引起的淋巴管组织肿瘤和/或结外淋巴瘤。

公开(公告)号：EP2356153B1

公开(公告)日：2016-05-04

申请号：EP09783664.7

申请日：2009-10-01

申请人： Amgen Research (Munich) GmbH

发明人： KUFER, Peter ,  RAUM, Tobias ,  KISCHEL, Roman ,  LUTTERBÜSE, Ralf ,  HOFFMANN, Patrick ,  RAU, Doris ,  MANGOLD, Susanne ,  KLINGER, Matthias ,  SCHALLER, Evelyne ,  HAUSMANN, Susanne ,  FLUHR, Petra ,  STEIGER, Carola

IPC分类号： C07K16/22 ,  C07K16/28 ,  C07K16/30 ,  C07K16/40 ,  A61K39/00

CPC分类号： C07K16/3069 ,  A61K2039/505 ,  C07K2317/31 ,  C07K2317/34

摘要： The present invention relates to a bispecific single chain antibody molecule comprising a first binding domain capable of binding to an epitope of human and non-chimpanzee primate CD3 epsilon chain, wherein the epitope is part of an amino acid sequence comprised in the group consisting of SEQ ID NOs. 2, 4, 6, and 8, and a second binding domain capable of binding to prostate-specific membrane antigen (PSMA). The invention also provides nucleic acids encoding said bispecific single chain antibody molecule as well as vectors and host cells and a process for its production. The invention further relates to pharmaceutical compositions comprising said bispecific single chain antibody molecule and medical uses of said bispecific single chain antibody molecule.

摘要翻译： 本发明涉及双特异性单链抗体分子，其包含能够结合人和非黑猩猩灵长类CD3ε链的表位的第一结合结构域，其中所述表位是包含在SEQ ID NO：1中的氨基酸序列的一部分 身份证号 2,4,6和8以及能够结合前列腺特异性膜抗原（PSMA）的第二结合结构域。 本发明还提供编码所述双特异性单链抗体分子的核酸以及载体和宿主细胞及其生产方法。 本发明还涉及包含所述双特异性单链抗体分子的药物组合物和所述双特异性单链抗体分子的医学应用。

公开(公告)号：EP2982696A3

公开(公告)日：2016-02-17

申请号：EP15185767.9

申请日：2009-11-06

申请人： Amgen Research (Munich) GmbH

发明人： ZUGMAIER, Gerhard ,  DEGENHARD, Evelyn

IPC分类号： C07K16/28 ,  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：EP2982696A2

公开(公告)日：2016-02-10

申请号：EP15185767.9

申请日：2009-11-06

申请人： Amgen Research (Munich) GmbH

发明人： ZUGMAIER, Gerhard ,  DEGENHARD, Evelyn

IPC分类号： C07K16/28 ,  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： 本发明涉及用于治疗，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其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：EP2953630A2

公开(公告)日：2015-12-16

申请号：EP14707953.7

申请日：2014-02-07

申请人： Amgen Research (Munich) GmbH

发明人： KLINGER, Matthias ,  HOFFMANN, Patrick ,  NAEGELE, Virginie ,  DOPFER, Elaine-Pashupati ,  NAGORSEN, Dirk ,  SCHEELE, Juergen ,  ZUGMAIER, Gerhard ,  KUFER, Peter

IPC分类号： A61K31/737

CPC分类号： C07K16/2809 ,  A61K31/10 ,  A61K31/65 ,  A61K39/3955 ,  C07K16/18 ,  C07K2317/70 ,  G01N33/5008 ,  G01N2500/04

摘要： The present invention relates in essence to use of a compound, which decreases or inhibits the binding of mammalian T-cells to mammalian endothelial cells for use in a method of prophylaxis and/or amelioration and/or treatment of clinical adverse events caused by a therapy which comprises re-directing of T-cells against target cells in a patient. Such a therapy includes, but is not limited to, treatment with an antibody comprising a CD3 binding domain, such as a CD20×CD3 or a CD19×CD3 bispecific single chain antibody, e.g., blinatumomab (MT-103). Methods of treatment of patients having or being at risk of clinical adverse events caused by therapy which comprises re-directing of T-cells against target cells are also contemplated, as are methods of identifying a compound for administration in the methods of prophylaxis, amelioration and/or treatment. Such anti-adhesive type compounds include, but are not limited to, antibodies, like natalizumab, efalizumab, and etrolizumab; minocycline, (acetyl-)salicyclic acid, astilbin, and flavonoids; and thrombin and pentosanpolysulfate (PPS), or a pharmaceutically acceptable salt thereof.

摘要翻译： 本发明在本质上涉及一种减少或抑制哺乳动物的T-细胞对哺乳动物内皮细胞中使用的结合通过疗法引起的预防和/或改善和/或治疗的临床不良事件的方法，其包括重新化合物 T细胞的患者中的引导针对靶细胞。 因此治疗的患有或在通过治疗包括T细胞重新定向针对靶细胞引起的临床不良事件的风险的患者的方法被考虑。