Antibody Information

General Information of This Antibody
Antibody ID
ANI0HNBAQ
Antibody Name
Anti-TIM1 CDX-014 mAb
Antibody Type
Monoclonal antibody (mAb)
Antibody Subtype
Humanized IgG1-kappa
Antigen Name
Hepatitis A virus cellular receptor 1 (HAVCR1)
  Antigen Info 
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Heavy Chain Sequence
MEFGLSWLFLVAILKGVQCQVQLVESGGGVVQPGRSLRLSCAASGFIFSRYGMHWVRQAP
GKGLKWVAVIWYDGSNKLYADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDYY
DNSRHHWGFDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVT
VSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRV
ESKYGPPCPSCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWY
VDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISK
AKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVL
DSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
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Light Chain Sequence
METPAQLLFLLLLWLPDTTGDIVMTQTPLSLPVTPGEPASISCRSSRSLLDSDDGNTYLD
WYLQKPGQSPQLLIYTLSYRASGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCMQRVEF
PITFGQGTRLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNAL
QSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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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
CDX-014 [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 Partial Response (PR)
6.20%
Patients Enrolled
Advanced clear cell or papillary renal cell carcinoma (RCC) who experienced progression after at least two lines of systemic therapy, including at least one TKI were included; Additional main inclusion criteria included measurable disease by Response Criteria in Solid Tumors (RECIST) 1.1 criteria, a Karnofsky performance status 70%, and adequate renal, hepatic, and hematological laboratory values.

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Administration Dosage
Intravenously at doses ranging from 0.15 to 2.00 mg/kg every 2 or 3 weeks until progression or unacceptable toxicity.
Related Clinical Trial
NCT Number NCT02837991  Clinical Status Phase 1
Clinical Description
A phase l open-label, dose escalation and cohort expansion study, to assess the safety and activity of the antibody-drug conjugate CDX-014 in advanced or metastatic renal cell carcinoma (RCC) and advanced or metastatic ovarian clear cell carcinoma (OCCC).
Primary Endpoint
One patient (6.20%) treated at 0.3 mg/kg every 3 weeks exhibited PR as best overall response,ongoing after 17 months on therapy; this patient had been on single agent PD-1 inhibition prior to initiating therapy with CDX-014. Five patients (31.00%) exhibited clinical benefit from CDX-014. PFS and OS were 2.70 months (95%CI 1.2-8.0) and 12.6 months (95%CI 5.7-12.6),respectively.

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Other Endpoint
Partial response (PR) = 6.00% of one patient treated at 0.30 mg/kg every 3 weeks as best overall response, clinical benefit from CDX-014 of five patients = (31.25%) exhibited of at least 6 months. PFS = 2.7 months (95%CI, 1.20-8.00) ,OS =12.6 months (95%CI, 5.70-12.60).
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) ≈ 20.00% Positive TIM1 expression (TIM1+++/++)
Method Description
Anti-TIM-1-vcMMAE (CDX-014=300 g), CDX-014 inhibited the increase in tumor volumes relative to saline control treatment.
In Vivo Model IGROV-1 xenograft mouse models
In Vitro Model Ovarian endometrioid adenocarcinoma IGROV-1 cells CVCL_1304
Experiment 2 Reporting the Activity Date of This ADC [2]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 21.00% Positive TIM1 expression (TIM1+++/++)
Method Description
Anti-TIM-1-vcMMAE (CDX-014=300 g).
In Vivo Model A549 xenograft mouse models
In Vitro Model Lung adenocarcinoma A-549 cells CVCL_0023
Experiment 3 Reporting the Activity Date of This ADC [2]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 22.90% Positive TIM1 expression (TIM1+++/++)
Method Description
Anti-TIM-1-vcMMAE (CDX-014=300 g).
In Vivo Model Caki-1 xenograft mouse model
In Vitro Model Clear cell renal cell carcinoma Caki-1 cells CVCL_0234
Experiment 4 Reporting the Activity Date of This ADC [2]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 40.50% Positive TIM1 expression (TIM1+++/++)
Method Description
Extended dosing of CDX-014 ADC in the A549 tumor model. Three cycles of four doses of CDX-014 prolong the inhibition of tumor growth.
In Vivo Model A549 xenograft mouse models
In Vitro Model Lung adenocarcinoma A-549 cells CVCL_0023
References
Ref 1 Safety and efficacy of CDX-014, an antibody-drug conjugate directed against T cell immunoglobulin mucin-1 in advanced renal cell carcinoma. Invest New Drugs. 2020 Dec;38(6):1807-1814.
Ref 2 Development of a Novel Antibody-Drug Conjugate for the Potential Treatment of Ovarian, Lung, and Renal Cell Carcinoma Expressing TIM-1. Mol Cancer Ther. 2016 Dec;15(12):2946-2954.

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