Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0KJHHN
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| ADC Name |
IMGN779
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| Synonyms |
IMGN779
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| Organization |
ImmunoGen (Top20 MNC) (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
3
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| Structure |
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| Antibody Name |
Z4681A
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Antibody Info | ||||
| Antigen Name |
Myeloid cell surface antigen CD33 (CD33)
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Antigen Info | ||||
| Payload Name |
DGN462
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Payload Info | ||||
| Therapeutic Target |
Human deoxyribonucleic acid (hDNA)
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Target Info | ||||
| Linker Name |
Sulfo-SPDB
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
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| Acute myeloid leukaemia |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Discovered Using Cell Line-derived Xenograft Model
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients must have relapsed/refractory AML (dose escalation) or be unsuitable for induction therapy (expansion), excluding those with acute promyelocytic leukemia, active CNS involvement, prior IMGN779 exposure, or recent anticancer therapy (within 14 days/five half-lives), as well as pregnant/breastfeeding women. Hydroxyurea or leukapheresis is permitted for hyperleukocytosis control.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT02674763 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, Multi-center, Open-label Study of IMGN779 Administered Intravenously in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia | ||||
| Primary Endpoint |
The primary objective is to determine the maximum tolerated dose (MTD) of IMGN779 in patients with relapsed or refractory acute myeloid leukemia (AML) over a 28-day period during the dose escalation phase.
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| Other Endpoint |
Secondary endpoints include evaluating treatment-emergent adverse events, objective response rate (ORR), pharmacokinetic parameters (Cmax, AUC, t½), and immunogenicity (anti-drug antibodies) over a 12-month observation period to assess safety, efficacy, and drug exposure characteristics.
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Discovered Using Cell Line-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100% | Positive CD33 expression (CD33+++/++) | ||
| Method Description |
IMGN779 (0.5 mg/kg, a single dose) induces efficient tumor cell killing in cell line-derived models of MV4-11 cells with CD33 expression with high expression.
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| In Vivo Model | MV4-11 CDX model | ||||
| In Vitro Model | Childhood acute monocytic leukemia | MV4-11 cells | CVCL_0064 | ||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100% | Positive CD33 expression (CD33+++/++) | ||
| Method Description |
EOL-1 tumor-bearing mice received a single intravenous bolus administration of vehicle, IMGN779, or Ab-DGN462, with each conjugate molecule dosed at approximately 1.5 mg/kg ADC by antibody concentration (i.e., 10 or 30 ug/kg linked IGN).
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| In Vivo Model | EOL-1 CDX model | ||||
| In Vitro Model | Chronic eosinophilic leukemia | EoL-1 cells | CVCL_0258 | ||
References