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1. 发明申请

US20090220501A1 Anti-CD19 Antibody, Immunotoxin and Treatment Method 审中-公开
标题翻译：抗CD19抗体，免疫毒素和治疗方法
公开(公告)号：US20090220501A1
公开(公告)日：2009-09-03
申请号：US12175368
申请日：2008-07-17
申请人： Georg H. Fey , Matthias Peipp , Michael Schwemmlein , Bruce Wang , Matthias Wabl
发明人： Georg H. Fey , Matthias Peipp , Michael Schwemmlein , Bruce Wang , Matthias Wabl
IPC分类号： A61K39/395 , C07K16/28
CPC分类号： C07K16/2803 , A61K47/6829 , A61K47/6849 , C07K2317/56 , C07K2319/04 , C12N2799/026
摘要： Provided is an immunotoxin including (a) an anti-CD19 antibody lacking an Fc fragment, (b) a modified exotoxin A protein having both Domains II and III, but lacking Domain I, and (c) a peptide linker joining the C-terminal end of the antibody to the N-terminal end of the modified exotoxin A protein. The linker is substantially resistant to extracellular cleavage. The modified exotoxin A protein may be further modified to include a C-terminal KDEL sequence (SEQ ID NO: 6) that promotes transport of the protein to the endoplasmic reticulum of cells that have taken up the immunotoxin. Also provided is an anti-CD19 antibody having enhanced binding activity, antibody-dependent cellular cytotoxicity (ADCC) and methods for using the antibody to treat a disease state associated with B-lineage cells that express CD19. The antibody variable light and variable heavy chains have unique sequences in their J region relative to known anti-CD19 antibody sequences.
摘要翻译：本发明提供一种免疫毒素，其包括（a）缺少Fc片段的抗CD19抗体，（b）具有两个结构域II和III的修饰的外毒素A蛋白，但缺少结构域I，和（c）连接C-端的肽接头抗体结合到修饰的外毒素A蛋白的N末端。接头基本上抗细胞外切割。修饰的外毒素A蛋白可以被进一步修饰以包括促进蛋白质转运到已经吸收免疫毒素的细胞的内质网的C-末端KDEL序列（SEQ ID NO：6）。还提供了具有增强的结合活性，抗体依赖性细胞毒性（ADCC）的抗CD19抗体以及使用该抗体治疗与表达CD19的B系细胞相关的疾病状态的方法。抗体可变轻链和可变重链相对于已知的抗CD19抗体序列在其J区具有独特的序列。

2. 发明申请

US20090297521A1 CD33-SPECIFIC SINGLE-CHAIN IMMUNOTOXIN AND METHODS OF USE 审中-公开
标题翻译： CD33特异性单链免疫弹性蛋白及其使用方法
公开(公告)号：US20090297521A1
公开(公告)日：2009-12-03
申请号：US11997246
申请日：2006-07-31
申请人： Georg H. Fey , Michael Schwemmlein
发明人： Georg H. Fey , Michael Schwemmlein
IPC分类号： A61K39/395 , C07K16/18 , C12N5/08 , A61P35/00
CPC分类号： C07K16/2803 , A61K2039/505 , C07K2317/622 , C07K2317/73 , C07K2319/55
摘要： A single-chain immunotoxin composition and method of treatment with the composition is disclosed. Preferably, the immunotoxin is comprised of a CD33-specific single chain Fv antibody fragment and a genetically engineered variant of Pseudomonas Exotoxin A (ETA). A preferred engineered Exotoxin A is referred to ETA′ and may includes a KDEL peptide at its C-terminus, a cellular peptide mediating improved retrograde transport to the endoplasmic reticulum (ER). The immunotoxin compound may be formulated with a carrier and administered into patients where the antibody portion binds to CD33-positive cells and kills those cells to provide an effective treatment for diseases such as human myeloid leukemia.
摘要翻译：公开了一种单链免疫毒素组合物及其组合物的处理方法。优选地，免疫毒素由CD33特异性单链Fv抗体片段和假单胞菌外毒素A（ETA）的遗传工程改造的变体组成。优选的工程设计的外毒素A被称为ETA'，并且可以在其C-末端包括KDEL肽，介导改善逆向向内质网（ER）转运的细胞肽。免疫毒素化合物可以与载体一起配制，并给予患者，其中抗体部分与CD33阳性细胞结合，并杀死那些细胞，以提供有效治疗疾病如人骨髓性白血病。

3. 发明申请

US20100291112A1 Recombinant, Single-Chain, Trivalent Tri-Specific or Bi-Specific Antibody Derivatives 审中-公开
标题翻译：重组，单链，三价三特异性或双特异性抗体衍生物
公开(公告)号：US20100291112A1
公开(公告)日：2010-11-18
申请号：US12668277
申请日：2008-07-10
申请人： Christian Kellner , Heiko Singer , Georg H. Fey , Jörg Brünke
发明人： Christian Kellner , Heiko Singer , Georg H. Fey , Jörg Brünke
IPC分类号： A61K39/395 , C12N15/13 , C12N15/63 , C12N5/07 , C12P21/00 , C07K16/30 , A61K31/7052 , A61P35/00
CPC分类号： C07K16/3061 , A61K2039/505 , C07K2317/31 , C07K2317/622
摘要： The present invention relates to a nucleic acid molecule encoding a polypeptide, wherein the polypeptide comprises (a) a first immunoglobulin domain comprising a VL domain linked to a VH domain, wherein the immunoglobulin domain specifically binds to an antigen expressed on tumour cells; (b) a second immunoglobulin domain comprising a VL domain linked to a VH domain, wherein the immunoglobulin domain specifically binds to an antigen expressed on tumour cells; and (c) a third immunoglobulin domain comprising a VL domain linked to a VH domain, wherein the immunoglobulin domain specifically binds to an effector cell antigen, wherein the effector cell is selected from the group consisting of NK cells, T cells, neutrophilic granulocytes, monocytes and macrophages; wherein at least one of the antigens expressed on tumour cells and bound by the immunoglobulin domain of (a) or (b) is an antigen expressed on tumour stem cells and/or on tumour precursor or progenitor cells; and wherein the ratio of immunoglobulin domains binding to antigens expressed on tumour cells and those binding to effector cell antigens is at least 2:1. The present invention furthermore relates to a vector comprising the nucleic acid molecule of the invention, a non-human host transformed with the vector of the invention, a method of producing a polypeptide comprising culturing the host of the invention under suitable conditions and isolating the polypeptide produced and a polypeptide encoded by the nucleic acid molecule of the invention or produced by the method of the invention. In addition, the present invention relates to diagnostic and pharmaceutical compositions and methods for treating tumours.
摘要翻译：本发明涉及编码多肽的核酸分子，其中所述多肽包含（a）包含与VH结构域连接的VL结构域的第一免疫球蛋白结构域，其中所述免疫球蛋白结构域特异性结合在肿瘤细胞上表达的抗原; （b）包含连接到VH结构域的VL结构域的第二免疫球蛋白结构域，其中所述免疫球蛋白结构域特异性结合在肿瘤细胞上表达的抗原; 和（c）包含连接到VH结构域的VL结构域的第三免疫球蛋白结构域，其中所述免疫球蛋白结构域特异性结合效应细胞抗原，其中所述效应细胞选自NK细胞，T细胞，嗜中性粒细胞，单核细胞和巨噬细胞; 其中在肿瘤细胞上表达并由（a）或（b）的免疫球蛋白结构域结合的抗原中的至少一种是在肿瘤干细胞和/或肿瘤前体或祖细胞上表达的抗原; 并且其中与在肿瘤细胞上表达的抗原结合的免疫球蛋白结构域与结合效应细胞抗原的抗体的比例至少为2:1。本发明还涉及包含本发明的核酸分子的载体，用本发明的载体转化的非人宿主，一种产生多肽的方法，包括在合适的条件下培养本发明的宿主并分离多肽或由本发明的核酸分子编码或通过本发明的方法生产的多肽。此外，本发明涉及用于治疗肿瘤的诊断和药物组合物和方法。

4. 发明申请

US20120328619A1 Trispecific Therapeutics Against Acute Myeloid Leukaemia 审中-公开
标题翻译：针对急性骨髓性白血病的特异性治疗
公开(公告)号：US20120328619A1
公开(公告)日：2012-12-27
申请号：US13514580
申请日：2010-12-09
申请人： Georg H. Fey , Christoph Stein , Christian Kellner , Markus Kügler
发明人： Georg H. Fey , Christoph Stein , Christian Kellner , Markus Kügler
IPC分类号： A61K39/395 , C07H21/00 , A61K31/7088 , A61P35/02 , C12N15/13 , A61K38/16 , C12N15/11 , C07K19/00 , A61P7/00 , C07K16/28 , C07K14/00
CPC分类号： C07K16/2803 , C07K16/283 , C07K16/2866 , C07K2317/31 , C07K2317/56 , C07K2317/622 , C07K2317/732 , C07K2317/92
摘要： The present invention relates to a molecule having binding specificities for (a) CD123; (b) CD16 and (c) CD33. The present invention further relates to the molecule of the invention, wherein the molecule comprises a first immunoglobulin domain comprising a VL domain linked to a VH domain, wherein the immunoglobulin domain specifically binds to CD123; a second immunoglobulin domain comprising a VL domain linked to a VH domain, wherein the immunoglobulin domain specifically binds to CD16; and a third immunoglobulin domain comprising a VL domain linked to a VH domain, wherein the immunoglobulin domain specifically binds to CD33. The present invention furthermore relates to a nucleic acid molecule encoding the molecule of the invention. In addition, the present invention relates to diagnostic and pharmaceutical compositions and the use of the molecule or the nucleic acid molecule of the invention in the treatment of acute myeloid leukaemia and/or myelodysplastic syndrome.
摘要翻译：本发明涉及具有（a）CD123的结合特异性的分子; （b）CD16和（c）CD33。本发明还涉及本发明的分子，其中分子包含第一免疫球蛋白结构域，其包含与VH结构域连接的VL结构域，其中免疫球蛋白结构域特异性结合CD123; 第二免疫球蛋白结构域，其包含连接到VH结构域的VL结构域，其中所述免疫球蛋白结构域特异性结合CD16; 和包含连接到VH结构域的VL结构域的第三免疫球蛋白结构域，其中所述免疫球蛋白结构域特异性结合CD33。本发明还涉及编码本发明分子的核酸分子。此外，本发明涉及诊断和药物组合物以及本发明的分子或核酸分子在治疗急性骨髓性白血病和/或骨髓增生异常综合征中的用途。

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