General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0JOHND
ADC Name
Gemtuzumab ozogamicin
Brand Name
Mylotarg
Synonyms
CDP-771; CL-555201; CMA-676; WAY-CMA-676; Anti-CD33-monoclonal-antibody-calicheamicin; Anti-CD33-monoclonal-antibody-p67-6-calicheamicin-conjugate; HP67-6-N-acetyl-gamma-dimethyl-acbut; hP67.6-calicheamicin; Human-anti-CD33-monoclonal-antibody-P67-6-calicheamicin-conjugate
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Organization
Pfizer Inc.; Wyeth Pharmaceuticals LLC
Drug Status
Approved (FDA): May 17, 2000; Withdrawn (FDA): Jun 21, 2010; Approved (FDA): Sep 2, 2017
Indication
In total 2 Indication(s)
Acute myelogenous leukemia [ICD11:2B33]
Approved
Leukemia [ICD11:2A60-2B33]
Terminated in phase 2
Drug-to-Antibody Ratio
2-3
Structure
Antibody Name
Gemtuzumab
 Antibody Info 
Antigen Name
Myeloid cell surface antigen CD33 (CD33)
 Antigen Info 
Payload Name
N-acetyl-gamma-calicheamicin
 Payload Info 
Therapeutic Target
Human Deoxyribonucleic acid (hDNA)
 Target Info 
Linker Name
AcButDMH
 Linker Info 
Conjugate Type
Random conjugation through nucleophilic lysines.
Combination Type
Ozogamicin
Absorption
In pediatric patients (9 mg/m2), the peak plasma concentration (Cmax) was approximately 3.47±1.04 (mg/L) with the AUC of 136 ±107 (mg x h/L).
Distribution
The volume of distribution at steady state (Vss) was approximately 6.5±5.5 L in pediatric patients receiving a dose level of 9mg/m2.
Metabolism
Metabolic studies indicate hydrolytic release of the calicheamicin derivative from gemtuzumab ozogamicin. The drug is most likely removed by opsonization via the reticuloendothelial system. In pediatric patients receiving a dose level of 9mg/m2, the half life was approximately 64±44 h after the first dose.
Elimination
The mean clearance rate was approximately 0.12±0.15 L/h/m2 in pediatric patients receiving a dose level of 9 mg/m2.
Toxicity
Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen.
Special Approval(s)
Accelerated approval(FDA); Orphan drug(FDA); Orphan drug(EMA)
Puchem SID
472422752 , 481101643 , 404336834 , 135302348 , 17397412 , 53787868 , 103771356 , 50067182 , 46505767 , 472227241 , 535599 , 329976984 , 349720813 , 178103381 , 441072532 , 440790288 , 468568988
Drugbank ID
DB00056
DrugMap ID
DMJ2O7B
TTD ID
D06EWO
DRESIS ID
DG00540
ChEBI ID
CHEMBL1201506
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Two-year Overall Survival (OS)  NCT00893399
Phase 3
Phase III study of chemotherapy in combination with atra with or without gemtuzumab ozogamicin in patients with acute myeloid leukemia and npm1 gene mutation.
Objective Response Rate (ORR)  NCT00909168
Phase 3
Induction, consolidation and intensification therapy for patients younger than 66 years with previously untreated CD33 positive acute myeloid leukemia (AML) (MYFLAI07).
Discovered Using Cell Line-derived Xenograft Model
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type Value Units Cell Line Disease Model
Tumor Growth Inhibition value (TGI) 
≈ 13.81
%
MV4-11 cells
Childhood acute monocytic leukemia
Revealed Based on the Cell Line Data
Click To Hide/Show 40 Activity Data Related to This Level
Standard Type Value Units Cell Line Disease Model
Half Maximal Inhibitory Concentration (IC50) 
20
pM
ML-2 cells
Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
30
pM
MOLM-13 cells
Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
30
pM
EoL-1 cells
Chronic eosinophilic leukemia
Half Maximal Inhibitory Concentration (IC50) 
40
pM
SKNO-1 cells
Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
70
pM
MV4-11 cells
Childhood acute monocytic leukemia
Half Maximal Inhibitory Concentration (IC50) 
90
pM
HL-60 cells
Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
90
pM
OCI-AML-1 cells
Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
0.1
nM
OCI-AML-4 cells
Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
0.1
nM
AML-193 cells
Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
0.1
nM
Kasumi-6 cells
Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 0.41
nM
KOPN-8 cells
Leukemia
Half Maximal Inhibitory Concentration (IC50) 
0.43
nM
MOLT-4 cells
Adult T acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
0.45
nM
SKM-1 cells
Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
0.52
nM
HNT-34 cells
Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
0.56
nM
RS4
11 cells
Adult B acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
0.58
nM
Reh cells
B acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
1.47
nM
LC4-1 cells
B acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
1.78
nM
SUP-B15 cells
B-lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
2.57
nM
THP-1 cells
Childhood acute monocytic leukemia
Half Maximal Inhibitory Concentration (IC50) 
2.92
nM
TALL-1 cells
T acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
3.31
nM
LOUCY cells
Adult T acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
8.02
nM
NALM-16 cells
Childhood B acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
8.03
nM
ATN-1 cells
T acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
8.56
nM
CCRF-CEM cells
T acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
8.61
nM
SUP-T1 cells
T lymphoblastic lymphoma
Half Maximal Inhibitory Concentration (IC50) 
8.91
nM
ARH-77 cells
Leukemia
Half Maximal Inhibitory Concentration (IC50) 
10.2
nM
Jurkat E6.1 cells
Leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
F-36P cells
Myelodysplastic syndrome
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
Kasumi-6 cells
Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
AML-193 cells
Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
Kasumi-3 cells
Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
KG-1a cells
Leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
NOMO-1 cells
Acute monocytic leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
Kasumi-1 cells
Myeloid leukemia with maturation
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
OCI-M1 cells
Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
PLB-985 cells
Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
CMK-11-5 cells
Acute megakaryoblastic leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
KU812 cells
Chronic myeloid leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
TF-1a cells
Acute erythroid leukemia
Half Maximal Inhibitory Concentration (IC50) 
> 20
nM
GDM-1 cells
Acute myeloid leukemia
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Two-year Overall Survival (OS)
69.00% (standard group); 73.00% (gemtuzumab ozogamicin group)
Patients Enrolled
Eligible participants were 18 years or older and had newly diagnosed NPM1-mutated acute myeloid leukaemia and an Eastern Cooperative Oncology Group performance status of 0-2.
Administration Dosage
Participants received two cycles of induction therapy plus all-trans retinoic acid (ATRA) followed by three consolidation cycles of high-dose cytarabine and ATRA, without or with gemtuzumab ozogamicin (3 mg/m2 i.v.on day 1 of induction cycles 1 and 2, and consolidation cycle 1).
Related Clinical Trial
NCT Number NCT00893399  Clinical Status Phase 3
Clinical Description Phase III study of chemotherapy in combination with atra with or without gemtuzumab ozogamicin in patients with acute myeloid leukemia and npm1 gene mutation.
Primary Endpoint
Short-term event-free survival at 6-month follow-up, 53.00% in the standard group and 58.00% in the gemtuzumab ozogamicin group.
Other Endpoint
CRi rates, n=267 (90%) in the standard group vs n=251 (86%) in the gemtuzumab ozogamicin group.
Experiment 2 Reporting the Activity Date of This ADC [2]
Efficacy Data Objective Response Rate (ORR) 85.00% Positive CD33 expression (CD33+++/++)
Patients Enrolled
Previously untreated primary or secondary acute myeloid leukemia (with bone marrow blasts 20%), express CD33 on blast cells.
Administration Dosage
3 mg/sqm single dose on day 6.
Related Clinical Trial
NCT Number NCT00909168  Clinical Status Phase 3
Clinical Description Induction, consolidation and intensification therapy for patients younger than 66 years with previously untreated CD33 positive acute myeloid leukemia (AML) (MYFLAI07).
Primary Endpoint
Objective response rate=85.00%, comprising 82.00% complete responses and 3.00% partial responses.
Other Endpoint
median DFS=61 months, median OS=63 months.
Discovered Using Cell Line-derived Xenograft Model
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 13.81% (Day 18) Positive CD33 expression (CD33+++/++)
Method Description
Subcutaneous tumor model MV4-11 human acute myelocytic leukemia cells (1x10 cells in 0.1 mL) were subcutaneously inoculated into the right flank of female athymic nude mice. Mice were treated with ADCs (iv, 0.1 mg/kg x 1) when tumors reached 150 mm3 and mouse body weight were measured twice per week.
In Vivo Model MV411 CDX model
In Vitro Model Childhood acute monocytic leukemia MV4-11 cells CVCL_0064
Revealed Based on the Cell Line Data
Click To Hide/Show 40 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 20.00 pM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute myeloid leukemia ML-2 cells CVCL_1418
Experiment 2 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 30.00 pM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Adult acute myeloid leukemia MOLM-13 cells CVCL_2119
Experiment 3 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 30.00 pM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Chronic eosinophilic leukemia EoL-1 cells CVCL_0258
Experiment 4 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 40.00 pM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Adult acute myeloid leukemia SKNO-1 cells CVCL_2196
Experiment 5 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 70.00 pM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Childhood acute monocytic leukemia MV4-11 cells CVCL_0064
Experiment 6 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 90.00 pM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Adult acute myeloid leukemia HL-60 cells CVCL_0002
Experiment 7 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 90.00 pM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Adult acute myeloid leukemia OCI-AML-1 cells CVCL_5228
Experiment 8 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 0.10 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute myeloid leukemia OCI-AML-4 cells CVCL_5224
Experiment 9 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 0.10 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute myeloid leukemia AML-193 cells CVCL_1071
Experiment 10 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 0.10 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute myeloid leukemia Kasumi-6 cells CVCL_0614
Experiment 11 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Leukemia KOPN-8 cells CVCL_1866
Experiment 12 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 0.43 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Adult T acute lymphoblastic leukemia MOLT-4 cells CVCL_0013
Experiment 13 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 0.45 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute myeloid leukemia SKM-1 cells CVCL_0098
Experiment 14 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 0.52 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute myeloid leukemia HNT-34 cells CVCL_2071
Experiment 15 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 0.56 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Adult B acute lymphoblastic leukemia RS4;11 cells CVCL_0093
Experiment 16 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 0.58 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model B acute lymphoblastic leukemia Reh cells CVCL_1650
Experiment 17 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 1.47 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model B acute lymphoblastic leukemia LC4-1 cells CVCL_1374
Experiment 18 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 1.78 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model B-lymphoblastic leukemia SUP-B15 cells CVCL_0103
Experiment 19 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 2.57 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Childhood acute monocytic leukemia THP-1 cells CVCL_0006
Experiment 20 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 2.92 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model T acute lymphoblastic leukemia TALL-1 cells CVCL_1736
Experiment 21 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 3.31 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Adult T acute lymphoblastic leukemia LOUCY cells CVCL_1380
Experiment 22 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 8.02 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Childhood B acute lymphoblastic leukemia NALM-16 cells CVCL_1834
Experiment 23 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 8.03 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model T acute lymphoblastic leukemia ATN-1 cells CVCL_1073
Experiment 24 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 8.56 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model T acute lymphoblastic leukemia CCRF-CEM cells CVCL_0207
Experiment 25 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 8.61 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model T lymphoblastic lymphoma SUP-T1 cells CVCL_1714
Experiment 26 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 8.91 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Leukemia ARH-77 cells CVCL_1072
Experiment 27 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) 10.20 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Leukemia Jurkat E6.1 cells CVCL_0367
Experiment 28 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Myelodysplastic syndrome F-36P cells CVCL_2037
Experiment 29 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute myeloid leukemia Kasumi-6 cells CVCL_0614
Experiment 30 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute myeloid leukemia AML-193 cells CVCL_1071
Experiment 31 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Adult acute myeloid leukemia Kasumi-3 cells CVCL_0612
Experiment 32 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Leukemia KG-1a cells CVCL_1824
Experiment 33 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute monocytic leukemia NOMO-1 cells CVCL_1609
Experiment 34 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Myeloid leukemia with maturation Kasumi-1 cells CVCL_0589
Experiment 35 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute myeloid leukemia OCI-M1 cells CVCL_2149
Experiment 36 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Positive CD33 expression (CD33+++/++)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Adult acute myeloid leukemia PLB-985 cells CVCL_2162
Experiment 37 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute megakaryoblastic leukemia CMK-11-5 cells CVCL_0217
Experiment 38 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Chronic myeloid leukemia KU812 cells CVCL_0379
Experiment 39 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute erythroid leukemia TF-1a cells CVCL_3608
Experiment 40 Reporting the Activity Date of This ADC [3]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 20.00 nM Negative CD33 expression (CD33-)
Method Description
The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model Acute myeloid leukemia GDM-1 cells CVCL_1230
References
Ref 1 Intensive chemotherapy with or without gemtuzumab ozogamicin in patients with NPM1-mutated acute myeloid leukaemia (AMLSG 09-09): a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2023 Jul;10(7):e495-e509. doi: 10.1016/S2352-3026(23)00089-3. Epub 2023 May 12.
Ref 2 Flai (fludarabine, cytarabine, idarubicin) plus low-dose Gemtuzumab Ozogamicin as induction therapy in CD33-positive AML: Final results and long term outcome of a phase II multicenter clinical trial. Am J Hematol. 2018 May;93(5):655-663. doi: 10.1002/ajh.25057. Epub 2018 Mar 2.
Ref 3 Neodegrader conjugates; 2021-10-07.

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