Antibody Information

General Information of This Antibody
Antibody ID
ANI0YCHBX
Antibody Name
Naratuximab
Organization
ImmunoGen, Inc.; Debiopharm International SA
Indication
B-cell lymphoma; Diffuse large B-cell lymphoma
Synonyms
K7153A
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Antibody Type
Monoclonal antibody (mAb)
Antibody Subtype
Chimeric IgG1-kappa
Antigen Name
Leukocyte antigen CD37 (CD37)
  Antigen Info 
Click to Show/Hide the Sequence Information of This Antibody
Heavy Chain Sequence
QVQVQESGPGLVAPSQTLSITCTVSGFSLTTSGVSWVRQPPGKGLEWLGVIWGDGSTNYH
PSLKSRLSIKKDHSKSQVFLKLNSLTAADTATYYCAKGGYSLAHWGQGTLVTVSSASTKG
PSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSL
SSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFL
FPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRV
VSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQ
VSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNV
FSCSVMHEALHNHYTQKSLSLSPG
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Heavy Chain Varible Domain
QVQVQESGPGLVAPSQTLSITCTVSGFSLTTSGVSWVRQPPGKGLEWLGVIWGDGSTNYH
PSLKSRLSIKKDHSKSQVFLKLNSLTAADTATYYCAKGGYSLAHWGQGTLVTVSS
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Heavy Chain Constant Domain 1
ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS
GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKV
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Heavy Chain Constant Domain 2
APELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTK
PREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAK
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Heavy Chain Constant Domain 3
GQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDS
DGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
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Heavy Chain Hinge Region
EPKSCDKTHTCPPCP
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Heavy Chain CDR 1
GFSLTTSG
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Heavy Chain CDR 2
IWGDGST
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Heavy Chain CDR 3
AKGGYSLAH
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Light Chain Sequence
DIQMTQSPSSLSVSVGERVTITCRASENIRSNLAWYQQKPGKSPKLLVNVATNLADGVPS
RFSGSGSGTDYSLKINSLQPEDFGTYYCQHYWGTTWTFGQGTKLEIKRTVAAPSVFIFPP
SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT
LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Light Chain Varible Domain
DIQMTQSPSSLSVSVGERVTITCRASENIRSNLAWYQQKPGKSPKLLVNVATNLADGVPS
RFSGSGSGTDYSLKINSLQPEDFGTYYCQHYWGTTWTFGQGTKLEIK
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Light Chain Constant Domain
RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD
SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Light Chain CDR 1
ENIRSN
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Light Chain CDR 2
VAT
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Light Chain CDR 3
QHYWGTTWT
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Naratuximab emtansine [Phase 2]
 ADC Info 
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
12.82%
Positive CD38 expression (CD38+++/++)
Patients Enrolled
Lymphoma limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL). Patients were also required to have received at least one prior anti-CD20 based therapeutic regimen, have a life expectancy of greater than 3 months, an Eastern Cooperative Oncology Group Performance status of 2 or lower, and adequate hematological, renal, and hepatic function.

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Administration Dosage
Conventional 3+3 dose-escalation design; intravenously once every 3 weeks; from 0.10 to 1.80 mg/kg.
Related Clinical Trial
NCT Number NCT01534715  Clinical Status Phase 1
Clinical Description
A phase 1, multi-center, open-label study of IMGN529 administered intravenously in adult patients with relapsed or refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia.
Primary Endpoint
A total of five objective responses were observed, resulting in an overall response rate (ORR) of 12.82% (N=39). Four of these (1 complete response [CR] and 3 partial responses [PRs]) occurred in patients with DLBCL, for an ORR of 22% in this lymphoma subset.
Discovered Using Cell Line-derived Xenograft Model
Click To Hide/Show 4 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [2]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 14.50% (Day 38) Positive CD38 expression (CD38+++/++)
Method Description
IMGN529 induces efficient tumor cell killing in cell line-derived models B-cell NHL of cells with lower CD27 expression, dosed at 2.5 ug/kg , 2 qw3.
In Vivo Model CD37-positive NHL and CLL model
In Vitro Model Non-Hodgkin lymphoma Non-Hodgkin lymphoma cells Homo sapiens
Chronic lymphocytic leukemia Chronic lymphocytic leukemia cells Homo sapiens
Experiment 2 Reporting the Activity Date of This ADC [2]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 99.00% (Day 38) Positive CD38 expression (CD38+++/++)
Method Description
IMGN529 induces efficient tumor cell killing in cell line-derived models B-cell NHL of cells with lower CD27 expression, dosed at 5 ug/kg , 2 qw3.
In Vivo Model CD37-positive NHL and CLL model
In Vitro Model Non-Hodgkin lymphoma Non-Hodgkin lymphoma cells Homo sapiens
Chronic lymphocytic leukemia Chronic lymphocytic leukemia cells Homo sapiens
Experiment 3 Reporting the Activity Date of This ADC [2]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 100.00% (Day 38) Positive CD38 expression (CD38+++/++)
Method Description
IMGN529 induces efficient tumor cell killing in cell line-derived models B-cell NHL of cells with lower CD27 expression, dosed at 10 ug/kg , 2 qw3.
In Vivo Model CD37-positive NHL and CLL model
In Vitro Model Non-Hodgkin lymphoma Non-Hodgkin lymphoma cells Homo sapiens
Chronic lymphocytic leukemia Chronic lymphocytic leukemia cells Homo sapiens
Experiment 4 Reporting the Activity Date of This ADC [2]
Efficacy Data Tumor Growth Inhibition value (TGI)
100.00% (10 mg/kg)
Positive CD38 expression (CD38+++/++)
Method Description
The inhibitory activity of SGN-LIV1A against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 1 day.
In Vivo Model DoHH2 CDX model
In Vitro Model Diffuse large B-cell lymphoma WSU-NHL cells CVCL_1793
Revealed Based on the Cell Line Data
Click To Hide/Show 5 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) < 0.10 nM
Method Description
In vitro cytotoxicity was measured by incubating 5000 target cells with indicated agents in complete RPMI-1640 media for 5 days at 37°C. The viability of remaining cells was determined by a colorimetric WST-10 assay.
In Vivo Model DoHH2 CDX model
In Vitro Model Diffuse large B-cell lymphoma germinal center B-cell type DoHH2 cells CVCL_1179
Experiment 2 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) < 0.10 nM
Method Description
In vitro cytotoxicity was measured by incubating 5000 target cells with indicated agents in complete RPMI-1640 media for 5 days at 37°C. The viability of remaining cells was determined by a colorimetric WST-11 assay.
In Vivo Model DoHH2 CDX model
In Vitro Model Mantle cell lymphoma Granta-519 cells CVCL_1818
Experiment 3 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) < 0.10 nM
Method Description
In vitro cytotoxicity was measured by incubating 5000 target cells with indicated agents in complete RPMI-1640 media for 5 days at 37°C. The viability of remaining cells was determined by a colorimetric WST-8 assay.
In Vivo Model DoHH2 CDX model
In Vitro Model Burkitt lymphoma BJAB cells CVCL_5711
Experiment 4 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) < 0.10 nM Positive CD38 expression (CD38+++/++)
Method Description
In vitro cytotoxicity was measured by incubating 5000 target cells with indicated agents in complete RPMI-1640 media for 5 days at 37°C. The viability of remaining cells was determined by a colorimetric WST-9 assay.
In Vivo Model DoHH2 CDX model
In Vitro Model Diffuse large B-cell lymphoma Farage cells CVCL_3302
Experiment 5 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) < 1.00 nM
Method Description
In vitro cytotoxicity was measured by incubating 5000 target cells with indicated agents in complete RPMI-1640 media for 5 days at 37°C. The viability of remaining cells was determined by a colorimetric WST-12 assay.
In Vivo Model DoHH2 CDX model
In Vitro Model Mantle cell lymphoma JVM-2 cells CVCL_1319
References
Ref 1 Safety, tolerability, and preliminary activity of IMGN529, a CD37-targeted antibody-drug conjugate, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a dose-escalation, phase I study. Invest New Drugs. 2018 Oct;36(5):869-876.
Ref 2 A novel anti-CD37 antibody-drug conjugate with multiple anti-tumor mechanisms for the treatment of B-cell malignancies. Blood. 2013 Nov 14;122(20):3500-10.

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