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公开(公告)号：US20210301017A1
公开(公告)日：2021-09-30
申请号：US17264373
申请日：2019-07-29
摘要： The present invention provides a bispecific antibody construct comprising a first binding domain specifically binding to a target such as CD33 and a second binding domain specifically binding to an effector such as CD3 for use in a method for the treatment of myeloid leukemia, wherein the construct is administered in one or more treatment cycles of more than 14 days applying a step dosing comprising at least two steps, a treatment cycle optionally followed by a period without administration of the construct. Moreover, the invention provides a method for the treatment of myeloid leukemia comprising the administration of a therapeutically efficient amount of such bispecific antibody construct and the use of such bispecific antibody construct for the preparation of a pharmaceutical composition for the treatment of myeloid leukemia.
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公开(公告)号：US09688760B2
公开(公告)日：2017-06-27
申请号：US14176091
申请日：2014-02-08
发明人： Peter Kufer , Dirk Nagorsen , Juergen Scheele , Gerhard Zugmaier , Matthias Klinger , Patrick Hoffmann , Virginie Naegele , Elaine-Pashupati Dopfer
IPC分类号： C07H21/04 , C07C43/00 , C07C49/00 , C07C237/26 , C07C331/00 , C12P21/08 , A01N37/18 , A61K31/65 , A01N31/00 , A61K31/095 , G01N33/00 , C12N5/071 , C07K16/28 , A61K31/10 , A61K39/395 , C07K16/18 , G01N33/50 , A61K39/00
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.
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公开(公告)号：US11579142B2
公开(公告)日：2023-02-14
申请号：US16217366
申请日：2018-12-12
发明人： Dirk Nagorsen
摘要： A method for assessing the risk of potential adverse effects for a human patient receiving is provided. The method comprises determining the total B count in the patient, and identifying a B cell number indicative of a patient at risk of potential adverse effects from the antibody. The method further provides a dosing schedule for administering the antibody to the patient identified as at risk of potential adverse effects. Also provided is a pharmaceutical package or kit comprising a first dose and a second dose, and optionally a third dose, the CD19×CD3 bispecific antibody as defined in the methods/dosage regimen of the disclosure.
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公开(公告)号：US10696744B2
公开(公告)日：2020-06-30
申请号：US14885404
申请日：2015-10-16
发明人： Gerhard Zugmaier , Dirk Nagorsen , Juergen Scheele
IPC分类号： C07K16/28 , A61K39/395 , A61K39/00
摘要： The present invention provides means and methods for treating diffuse large B cell lymphoma (DLBCL). Specifically, a bispecific CD19×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.
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5.发明申请PPS for the prevention of potential adverse effects caused by CD3 specific binding domains 有权PPS用于预防CD3特异性结合结构域引起的潜在不良反应公开(公告)号：US20140228316A1
公开(公告)日：2014-08-14
申请号：US14176089
申请日：2014-02-08
发明人： Peter Kufer , Dirk Nagorsen , Juergen Scheele , Gerhard Zugmaier , Matthias Klinger , Patrick Hoffmann , Virginie Naegele , Elaine-Pashupati Dopfer
IPC分类号： A61K31/737
CPC分类号： A61K31/737
摘要： The present invention relates to a PPS for use in the amelioration, treatment or prophylaxis of neurological adverse events caused by a CD3 binding domain. Kits comprising a PPS, a CD3 binding domain and instructions for use which indicate that the PPS is to be employed for the treatment amelioration and/or prophylaxis of neurological adverse events caused by said CD3 binding domain, are also disclosed.
摘要翻译： 本发明涉及用于改善，治疗或预防由CD3结合结构域引起的神经不良事件的PPS。 还公开了包含PPS，CD3结合结构域的试剂盒和用于指示PPS用于治疗由所述CD3结合结构域引起的神经功能不良事件的改善和/或预防的使用说明书。
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公开(公告)号：US11084876B2
公开(公告)日：2021-08-10
申请号：US15604341
申请日：2017-05-24
发明人： Peter Kufer , Dirk Nagorsen , Juergen Scheele , Gerhard Zugmaier , Matthias Klinger , Patrick Hoffmann , Virginie Naegele , Elaine-Pashupati Dopfer
摘要： The present invention relates in essence to 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 therapy which comprises re-directing of T-cells against target cells in a patient. 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.
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公开(公告)号：US20190142846A1
公开(公告)日：2019-05-16
申请号：US16157985
申请日：2018-10-11
发明人： Gerhard Zugmaier , Dirk Nagorsen , Juergen Scheele
IPC分类号： A61K31/573 , A61K39/395 , C07K16/28
摘要： The present invention relates to a glucocorticoid (GC) for use in the amelioration, treatment or prophylaxis of neurological/psychiatric adverse events caused by a CD3 binding domain. Kits comprising a GC, a CD3 binding domain and instructions for use which indicate that the GC is to be employed for the treatment amelioration and/or prophylaxis of neurological adverse events caused by said CD3 binding domain, are also disclosed.
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8.发明授权PPS for the prevention of potential adverse effects caused by CD3 specific binding domains 有权PPS用于预防CD3特异性结合结构域引起的潜在不良反应公开(公告)号：US09486475B2
公开(公告)日：2016-11-08
申请号：US14176089
申请日：2014-02-08
发明人： Peter Kufer , Dirk Nagorsen , Juergen Scheele , Gerhard Zugmaier , Matthias Klinger , Patrick Hoffmann , Virginie Naegele , Elaine-Pashupati Dopfer
IPC分类号： A01N43/04 , A61K31/715 , A61K31/737
CPC分类号： A61K31/737
摘要： The present invention relates to a pentosanpolysulfate (PPS) or a pharmaceutically acceptable salt thereof for use in the amelioration, treatment, or prevention of adverse neurological events caused by administering an antibody or fragment thereof comprising a CD3 binding domain, including a CD19 x CD3 bispecific single chain antibody, such as blinatumomab. PPS is a semi-synthetically produced heparin-like macromolecular carbohydrate derivative, which chemically and structurally resembles glycosaminoglycans. Kits comprising a PPS, an antibody or fragment thereof comprising a CD3 binding domain, and instructions for administration, which indicate that the PPS is to be employed for the amelioration, treatment or prevention of adverse neurological events caused by administering the antibody or fragment thereof comprising said CD3 binding domain, are also disclosed.
摘要翻译： 本发明涉及一种戊糖聚硫酸酯（PPS）或其药学上可接受的盐，用于改善，治疗或预防由施用包含CD3结合结构域的抗体或其片段引起的不良神经系统事件，包括CD19×CD3双特异性 单链抗体，如blinatumomab。 PPS是半合成生产的肝素样大分子碳水化合物衍生物，其化学和结构上类似于糖胺聚糖。 包含PPS，抗体或其片段的试剂盒，其包含CD3结合结构域和给药指示，其指示PPS用于改善，治疗或预防由施用抗体或其片段引起的不良神经系统事件，所述抗体或片段包含 所述CD3结合结构域也被公开。
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公开(公告)号：US20150071928A1
公开(公告)日：2015-03-12
申请号：US14491459
申请日：2014-09-19
发明人： Dirk Nagorsen , Peter Kufer , Gerhard Zugmaier , Patrick Bauerle
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 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，施用第三剂量的所述抗体持续第三个时间段。 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。 本发明还涉及使用CD19×CD3双特异性抗体制备用于本发明方法的药物组合物。 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。
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公开(公告)号：US11633408B2
公开(公告)日：2023-04-25
申请号：US16157985
申请日：2018-10-11
发明人： Gerhard Zugmaier , Dirk Nagorsen , Juergen Scheele
IPC分类号： A61K31/573 , A61K39/395 , C07K16/28 , A61K39/00
摘要： The present invention relates to a glucocorticoid (GC) for use in the amelioration, treatment or prophylaxis of neurological/psychiatric adverse events caused by a CD3 binding domain. Kits comprising a GC, a CD3 binding domain and instructions for use which indicate that the GC is to be employed for the treatment amelioration and/or prophylaxis of neurological adverse events caused by said CD3 binding domain, are also disclosed.
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