CN116829600A - 靶向cd5的全人源抗体 - Google Patents
靶向cd5的全人源抗体 Download PDFInfo
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- CN116829600A CN116829600A CN202280009712.2A CN202280009712A CN116829600A CN 116829600 A CN116829600 A CN 116829600A CN 202280009712 A CN202280009712 A CN 202280009712A CN 116829600 A CN116829600 A CN 116829600A
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
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Abstract
Description
分析物 | KD(M) | kon(1/Ms) | kdis(1/s) |
#42IgG | 2.90E-09 | 4.80E+04 | 1.39E-04 |
#61IgG | 3.96E-09 | 7.28E+04 | 2.88E-04 |
#61-42IgG | 1.67E-09 | 1.13E+05 | 1.89E-04 |
#62IgG | 2.74E-08 | 1.25E+04 | 3.09E-04 |
#60IgG | 8.32E-09 | 2.55E+04 | 2.12E-04 |
Claims (39)
- 靶向CD5的抗体或其抗原结合片段,其中所述抗体包括重链可变区(HCVR),所述重链可变区包括HCDR1、HCDR2和HCDR3,所述HCDR1、HCDR2和HCDR3选自如下组合之一:(1)HCDR1的氨基酸序列为GFTFSHSA(SEQ ID NO:1);HCDR2的氨基酸序列为IYARGGYT(SEQ ID NO:2);HCDR3的氨基酸序列为ARGYHLEYMVSQDV(SEQ ID NO:3);(2)HCDR1的氨基酸序列为GFTFSSYE(SEQ ID NO:4);HCDR2的氨基酸序列为ISSSGSTI(SEQ ID NO:5);HCDR3的氨基酸序列为ARVAQREGDV(SEQ ID NO:6);(3)HCDR1的氨基酸序列为GGTFSNYA(SEQ ID NO:7);HCDR2的氨基酸序列为ISAYNGDT(SEQ ID NO:8);HCDR3的氨基酸序列为ARYESMSGQDI(SEQ ID NO:9);(4)HCDR1的氨基酸序列为GYSFSNHW(SEQ ID NO:10);HCDR2的氨基酸序列为VYPGDSDT(SEQ ID NO:11);HCDR3的氨基酸序列为ARGGTIDGDYGGRQDF(SEQ ID NO:12);或所述抗体包括(1)-(4)任一项中的CDR序列组合的变体,其中所述变体(1)-(4)任一项中的CDR序列相比,具有至少90%的序列一致性,或在CDR序列上共包含至少1个且不超过10,或不超过5、4、3、2或1个氨基酸改变。
- 如权利要求1所述的抗体或其抗原结合片段,其中所述重链可变区的氨基酸序列选自如下任一项:(1)SEQ ID NO:17所示序列或与其有至少90%序列一致性的重链可变区序列;(2)SEQ ID NO:18所示序列或与其有至少90%序列一致性的重链可变区序列;(3)SEQ ID NO:19所示序列或与其有至少90%序列一致性的重链可变区序列;(4)SEQ ID NO:20所示序列或与其有至少90%序列一致性的重链可变区序列。
- 如权利要求1或2所述的抗体或其抗原结合片段,其中所述重链可变区的氨基酸序列选自如下任一项:(1)SEQ ID NO:17所示的重链可变区序列;(2)SEQ ID NO:18所示的重链可变区序列;(3)SEQ ID NO:19所示的重链可变区序列;(4)SEQ ID NO:20所示的重链可变区序列。
- 如权利要求1-3任一项所述的抗体或其抗原结合片段,其中所述抗体为单域抗体。
- 如权利要求1-4任一项所述的抗体或其抗原结合片段,其中所述抗体为全人源抗体。
- 如权利要求1-5任一项所述的抗体或其抗原结合片段,其中通过生物膜干涉技术测定的所述抗体对CD5抗原的结合KD值低于10 -7M,优选低于10 -8M。
- 融合蛋白,包括一个或两个抗原结合功能部分,其中每个所述抗原结合功能部分包括权利要求1-6任一项所述的抗体或其抗原结合片段,优选地,所述融合蛋白还包括Fc片段。
- 如权利要求7所述的融合蛋白,其中所述两个抗原结合功能部分分别结合相同或不同的抗原表位。
- 如权利要求7或8所述的融合蛋白,包括串联连接的第一抗原结合功能部分和第二抗原结合功能部分;其中所述第一抗原结合功能部分包括第一重链可变区(HCVR),所述第一重链可变区包括SEQ ID NO:7所示的HCDR1、SEQ ID NO:8所示的HCDR2和SEQ ID NO:9所示的HCDR3;其中所述第二抗原结合功能部分包括第二重链可变区(HCVR),所述第二重链可变区包括SEQ ID NO:1所示的HCDR1、SEQ ID NO:2所示的HCDR2和SEQ ID NO:3所示的HCDR3。
- 如权利要求7-9任一项所述的融合蛋白,包括串联连接的SEQ ID NO:19所示的重链可变区序列和SEQ ID NO:17所示的重链可变区序列。
- 如权利要求7-10任一项所述的融合蛋白,其中所述抗原结合功能部分直接通过接头分子连接;优选地,所述接头分子包括SEQ ID NO:21所示的氨基酸序列。
- 如权利要求7-11任一项所述的融合蛋白,其中通过流式细胞术测定的所述融合蛋白与CD5阳性细胞之间结合的EC 50值在1-5nM。
- 编码权利要求1-6任一项的抗体或其抗原结合片段或权利要求7-12任一项所述的融合蛋白的核酸分子。
- 如权利要求13所述的核酸分子,其包括SEQ ID NO:13-16任一项所示的核苷酸序列。
- 一种表达载体,其包括权利要求13或14所述的核酸分子。
- 一种宿主细胞,其包括权利要求15所述的表达载体。
- 一种药物组合物,其包括1)权利要求1-6任一项的抗体或其抗原结合片段,或者权利要求7-12任一项所述的融合蛋白;以及2)药学上可接受的载体或稀释剂。
- 一种治疗疾病或病症的方法,所述方法包括通过向有需要的患者施用治疗有效量的权利要求1-6任一项所述的抗体或其抗原结合片段,权利要求7-12任一项所述的融合蛋白,权利要求16所述的宿主细胞,或权利要求17所述的药物组合物,以消除、抑制或降低CD5活性,从而预防、减轻、改善或抑制疾病或病症。
- 如权利要求18所述的方法,其中所述疾病或病症选自:癌症。
- 如权利要求19所述的方法,其中所述癌症选自:T细胞恶性肿瘤。
- 与权利要求1-6任一项的抗体或其抗原结合片段竞争相同表位的抗体或片段。
- 一种试剂盒,用于检测样品中CD5蛋白,其中,所述试剂盒包括权利要求1-6任一项所述的抗体或其抗原结合片段,或权利要求7-12任一项所述的融合蛋白。
- 权利要求1-6任一项所述的抗体或其抗原结合片段,权利要求7-12任一项所述的融合蛋白,或权利要求16所述的宿主细胞在制备用于消除、抑制或降低CD5活性,从而预防、减轻、改善或抑制疾病或病症的药物中的用途。
- 如权利要求23所述的用途,其中所述疾病或病症选自:癌症或自身免疫疾病。
- 如权利要求24所述的用途,其中所述癌症选自:恶性T细胞肿瘤或恶性B细胞肿瘤。
- 如权利要求25所述的用途,其中所述恶性T细胞肿瘤选自T细胞急性淋巴细胞白血病(T-ALL)、T细胞淋巴瘤(TCL),所述恶性B细胞肿瘤选自慢性淋巴细胞白血病(B-CLL)或套细胞淋巴瘤(B-MCL)。
- 多特异性抗体分子,至少包括第一功能部分和第二功能部分,其中第一功能部分包括权利要求1-6任一项所述的抗体或其抗原结合片段;第二功能部分具有与所述第一功能部分不同的结合特异性。
- 如权利要求27所述的多特异性抗体分子,其中第二功能部分对免疫细胞具有结合特异性。
- 如权利要求27或28所述的多特异性抗体分子,其中所述第二功能部分对T细胞具有结合特异性。
- 如权利要求27-29任一项所述的多特异性抗体分子,其中所述第二功能部分对CD7具有结合特异性。
- 免疫偶联物,包括与治疗剂连接的权利要求1-6中任一项所述的抗体或其抗原结合片段。
- 如权利要求31所述的免疫偶联物,其中所述治疗剂是药物。
- 如权利要求31或32所述的免疫偶联物,其中所述治疗剂是细胞毒素。
- 如权利要求31-33任一项所述的免疫偶联物,其中所述治疗剂是放射性同位素。
- 权利要求1-6任一项所述的抗体或其抗原结合片段、权利要求7-12任一项所述的融合蛋白、权利要求27-30任一项所述的多特异性抗体分子或权利要求31-34任一项所述的免疫偶联物在制备用于消除、抑制或降低CD5活性的药物中的用途。
- 如权利要求35所述的用途,其中所述药物用于预防、减轻、改善或抑制癌症或自身免疫疾病。
- 如权利要求36所述的用途,其中所述癌症选自:恶性T细胞肿瘤或恶性B细胞肿瘤。
- 如权利要求1-6任一项所述的抗体或其抗原结合片段、权利要求7-12任一项所述的融合蛋白、权利要求27-30任一项所述的多特异性抗体分子或权利要求31-34任一项所述的免疫偶联物的用途,用于制备疫苗,较佳地为抗体疫苗,更佳地为抗独特型抗体疫苗。
- 一种疫苗制品,其包括如权利要求1-6任一项所述的抗体或其抗原结合片段、权利要求7-12任一项所述的融合蛋白、权利要求27-30任一项所述的多特异性抗体分子或权利要求31-34任一项所述的免疫偶联物。
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Effective date of registration: 20231213 Address after: 210061 10th floor, building D, phase II, Zhongdan Ecological Life Science Industrial Park, no.3-1, xinjinhu Road, Jiangbei new district, Nanjing City, Jiangsu Province Applicant after: Nanjing Reindeer Biotechnology Co.,Ltd. Applicant after: Nanjing reindeer biomedical Co.,Ltd. Address before: 210061 10th floor, building D, phase II, Zhongdan Ecological Life Science Industrial Park, no.3-1, xinjinhu Road, Jiangbei new district, Nanjing City, Jiangsu Province Applicant before: Nanjing Reindeer Biotechnology Co.,Ltd. |
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