CN105026428A - PD-l抗体、其抗原结合片段及其医药用途 - Google Patents
PD-l抗体、其抗原结合片段及其医药用途 Download PDFInfo
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Abstract
Description
名称 | 序列 | 编号 |
HCDR1 | SYMMS | SEQID NO:3 |
HCDR2 | TISGGGANTYYPDSVKG | SEQID NO:4 |
HCDR3 | QLYYFDY | SEQID NO:5 |
LCDR1 | LASQTIGTWLT | SEQID NO:6 |
LCDR2 | TATSLAD | SEQID NO:7 |
LCDR3 | QQVYSIPWT | SEQID NO:8 |
待测抗体 | ka(1/Ms) | kd(1/s) | KD(M) |
mAb005 | 1.057E+5 | 3.769E-4 | 3.566E-9 |
HC | LC | |
H005-1 | SEQID NO:11 | SEQID NO:12 |
H005-2 | SEQID NO:11,G44R | SEQID NO:12 |
H005-3 | SEQID NO:11 | SEQID NO:12,A43S |
H005-4 | SEQID NO:11,G44R | SEQID NO:12,A43S |
待测抗体 | ELISA,EC50,nM | LBB assay,IC50,nM | KD(M) |
H005-1 | 0.11 | 1.27 | 2.79E-09 |
H005-2 | 0.14 | 1.27 | 2.98E-09 |
H005-3 | 0.15 | 1.33 | 2.45E-09 |
H005-4 | 0.14 | 1.36 | 3.89E-09 |
Sample | T cell proliferation EC50(ng/ml) | IFN-λ EC50(ng/ml) |
H005-1 | 15.95±17.15 | 56.87±48.53 |
Claims (27)
- 一种PD-1抗体或其抗原结合片段,其包含:抗体轻链可变区,所述的抗体轻链可变区包含至少1个选自如以下序列所示的LCDR:SEQ ID NO:6,SEQ ID NO:7或SEQ ID NO:8;和抗体重链可变区,所述的抗体重链可变区包含至少1个选自如以下序列所述的HCDR:SEQ ID NO:3,SEQ ID NO:4或SEQ ID NO:5。
- 如权利要求1所述的PD-1抗体或其抗原结合片段,其中所述的抗体轻链可变区包含如SEQ ID NO:6所示的LCDR1。
- 如权利要求1所述的PD-1抗体或其抗原结合片段,其中所述的抗体轻链可变区包含如SEQ ID NO:7所示的LCDR2。
- 如权利要求1所述的PD-1抗体或其抗原结合片段,其中所述的抗体轻链可变区包含如SEQ ID NO:8所示的LCDR3。
- 如权利要求1所述的PD-1抗体或其抗原结合片段,其中所述的抗体重链可变区包含如SEQ ID NO:3所示的HCDR1。
- 如权利要求1所述的PD-1抗体或其抗原结合片段,其中所述的抗体重链可变区包含如SEQ ID NO:4所示的HCDR2。
- 如权利要求1所述的PD-1抗体或其抗原结合片段,其中所述的抗体重链可变区包含如SEQ ID NO:5所示的HCDR3。
- 如权利要求1所述的PD-1抗体或其抗原结合片段,其中所述的抗体轻链可变区包含分别如SEQ ID NO:6、SEQ ID NO:7和SEQ ID NO:8所示的LCDR1、LCDR2和LCDR3。
- 如权利要求1所述的PD-1抗体或其抗原结合片段,其中所述的抗体重链可变区包含分别如SEQ ID NO:3、SEQ ID NO:4和SEQ ID NO:5所示的HCDR1、HCDR2和HCDR3。
- 如权利要求1所述的PD-1抗体或其抗原结合片段,其中所述的抗体轻链可变区包含分别如SEQ ID NO:6、SEQ ID NO:7和SEQ ID NO:8所示的LCDR1、LCDR2和LCDR3;且其中所述的抗体重链可变区包含分别如SEQ ID NO:3、SEQ ID NO:4和SEQ ID NO:5所示的HCDR1、HCDR2和HCDR3。
- 如权利要求1-10任一项所述的PD-1抗体或其抗原结合片段,其中所述的抗体或其抗原结合片段为鼠源抗体或其片段。
- 如权利要求1-10任一项所述的PD-1抗体或其抗原结合片段,其中所述的抗体或其抗原结合片段为嵌合抗体或其片段。
- 如权利要求12所述的PD-1抗体或其抗原结合片段,其中所述的嵌合抗体轻链可变区序列为:SEQ ID NO:10。
- 如权利要求12所述的PD-1抗体或其抗原结合片段,其中所述的嵌合抗体重链可变区序列为:SEQ ID NO:9。
- 如权利要求1-10任一项所述的PD-1抗体或其抗原结合片段,其中所述的抗体或其抗原结合片段为人源化抗体或其片段。
- 如权利要求15所述的PD-1抗体或其抗原结合片段,其中所述人源化抗体轻链可变区上的轻链FR区序列,来源于如SEQ ID NO:14所示的人种系轻链IGKV1-39和JK4的组合序列;其包含人种系轻链IGKV 1-39的FR1,FR2,FR3区和JK4的FR4区。
- 如权利要求15所述的PD-1抗体或其抗原结合片段,其中所述人源化抗体轻链序列为如SEQ ID NO:12所示的序列或其变体;所述的变体优选在轻链可变区有0-10的氨基酸变化;更优选为A43S的氨基酸变化。
- 如权利要求15所述的PD-1抗体或其抗原结合片段,其中所述人源化抗体重链可变区进一步包含人源IgG1,IgG2,IgG3或IgG4或其变体的重链FR区,优选包含人源IgG2或IgG4重链FR区。
- 如权利要求15所述的PD-1抗体或其抗原结合片段,其中所述人源化抗体重链可变区上的重链FR区序列,来源于如SEQ ID NO:13所示的人种系重链IgHV3-7和JH6的组合序列;其包含人种系重链IgHV3-7的FR1,FR2,FR3区和JH6的FR4区。
- 如权利要求15所述的PD-1抗体或其抗原结合片段,其中所述人源化抗体重链序列为如SEQ ID NO:11所示的序列或其变体;所述变体优选在重链可变区有0-10的氨基酸变化;更优选为G44R的氨基酸变化。
- 一种编码如权利要求1-20任一项所述的抗体的DNA分子。
- 一种含有如权利要求21所述的DNA分子的表达载体。
- 一种用如权利要求22所述的表达载体转化的宿主细胞。
- 如权利要求23所述的宿主细胞,其中所述的宿主细胞为细菌,优选为大肠杆菌。
- 如权利要求23所述的宿主细胞,其中所述的宿主细胞为酵母菌,优选为毕赤酵母。
- 一种药物组合物,其含有如权利要求1至20任一项所述的PD-1抗体或其抗原结合片段和可药用的赋形剂、稀释剂或载体。
- 如权利要求1至20任一项所述的PD-1抗体或其抗原结合片段、如权利要求26所述的药物组合物,在制备用于治疗PD-1介导的疾病或病症的药物中的用途,其中所述的疾病或病症优选为癌症;更优选为表达PD-L1的癌症;最优选为乳腺癌、肺癌、胃癌、肠癌、肾癌、黑素瘤、非小细胞肺癌;最优选为非小细胞肺癌、黑素瘤和肾癌。
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