ADC ID	DRG0KFPTZ
ADC Name	CDX-0125-TEI
Synonyms	CDX-0125 TEI    Click to Show/Hide
Drug Status	Investigative
Indication	In total 1 Indication(s) Neuroblastoma [ICD11:2A00] Investigative
Drug-to-Antibody Ratio	2.7
	3D MOL			2D MOL
Antibody Name	Anti-ALK mAb DX-0125					Antibody Info
Antigen Name	ALK tyrosine kinase receptor (ALK)					Antigen Info
Payload Name	NMS-P945					Payload Info
Therapeutic Target	Human Deoxyribonucleic acid (hDNA)					Target Info
Linker Name	Undisclosed

Standard Type	Value	Units	Animal Model (No. of PDX)
Tumor Growth Inhibition value (TGI)	≈ 10.13	%	Neuroblastoma PDX model (PDX: COG-N-424x)
Tumor Growth Inhibition value (TGI)	≈ 15.15	%	Neuroblastoma PDX model (PDX: ALK F1174L)
Tumor Growth Inhibition value (TGI)	≈ 39.21	%	Neuroblastoma PDX model (PDX: ALK F1245C)
Tumor Growth Inhibition value (TGI)	≈ 44.99	%	Neuroblastoma PDX model (PDX: ALK F1245C)
Tumor Growth Inhibition value (TGI)	≈ 54.55	%	Neuroblastoma PDX model (PDX: ALK F1174L)
Tumor Growth Inhibition value (TGI)	≈ 71.66	%	Neuroblastoma PDX model (PDX: ALK F1174L)
Tumor Growth Inhibition value (TGI)	≈ 85.83	%	Neuroblastoma PDX model (PDX: ALK F1245C)
Tumor Growth Inhibition value (TGI)	≈ 86.39	%	Neuroblastoma PDX model (PDX: COG-N-424x)

Standard Type	Value	Units	Cell Line	Disease Model
Tumor Growth Inhibition value (TGI)	≈ 11.43	%	NBL-S cells	Neuroblastoma
Tumor Growth Inhibition value (TGI)	≈ 89.71	%	NBL-S cells	Neuroblastoma

Standard Type	Value	Units	Cell Line	Disease Model
Half Maximal Inhibitory Concentration (IC50)	4.7	pM	IMR-32 cells	Neuroblastoma
Half Maximal Inhibitory Concentration (IC50)	5.8	pM	NB-1 cells	Buccal mucosa squamous cell carcinoma
Half Maximal Inhibitory Concentration (IC50)	21.7	pM	SK-N-SH cells	Neuroblastoma
Half Maximal Inhibitory Concentration (IC50)	> 1000	pM	SK-N-AS cells	Neuroblastoma

Experiment 1 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 10.13% (Day 15)	Positive ALK expression (ALK+++/++)
Method Description	The in vivo efficacy of CDX-0125-TEI was evaluated in female CB17 SCID mice bearing COG-N-424x (ALK wild-type). Upon enrollment, mice (n = 10 per group) were intraperitoneally injected with 10 mg/kg CDX-0125-TE on day 0 of enrollment and on day 7.
In Vivo Model	Neuroblastoma PDX model (PDX: COG-N-424x)
Experiment 2 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 15.15% (Day 21)	Moderate ALK expression (ALK++)
Method Description	Mice (n = 10 per group) were intraperitoneally injected with the following drugs: IgG, unconjugated CDX-0125, or CDX-0125-TEI once a week for two consecutive weeks at a range of doses 1 mg/kg.
In Vivo Model	Neuroblastoma PDX model (PDX: ALK F1174L)
Experiment 3 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 39.21% (Day 19)	Positive ALK expression (ALK+++/++)
Method Description	Mice (n = 10 per group) were intraperitoneally injected with the following drugs: IgG, unconjugated CDX-0125, or CDX-0125-TEI once a week for two consecutive weeks at a range of doses 1 mg/kg.
In Vivo Model	Neuroblastoma PDX model (PDX: ALK F1245C)
Experiment 4 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 44.99% (Day 19)	Positive ALK expression (ALK+++/++)
Method Description	Mice (n = 10 per group) were intraperitoneally injected with the following drugs: IgG, unconjugated CDX-0125, or CDX-0125-TEI once a week for two consecutive weeks at a range of doses 3 mg/kg.
In Vivo Model	Neuroblastoma PDX model (PDX: ALK F1245C)
Experiment 5 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 54.55% (Day 21)	Moderate ALK expression (ALK++)
Method Description	Mice (n = 10 per group) were intraperitoneally injected with the following drugs: IgG, unconjugated CDX-0125, or CDX-0125-TEI once a week for two consecutive weeks at a range of doses 3 mg/kg.
In Vivo Model	Neuroblastoma PDX model (PDX: ALK F1174L)
Experiment 6 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 71.66% (Day 21)	Moderate ALK expression (ALK++)
Method Description	Mice (n = 10 per group) were intraperitoneally injected with the following drugs: IgG, unconjugated CDX-0125, or CDX-0125-TEI once a week for two consecutive weeks at a range of doses 10 mg/kg.
In Vivo Model	Neuroblastoma PDX model (PDX: ALK F1174L)
Experiment 7 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 85.83% (Day 19)	Positive ALK expression (ALK+++/++)
Method Description	Mice (n = 10 per group) were intraperitoneally injected with the following drugs: IgG, unconjugated CDX-0125, or CDX-0125-TEI once a week for two consecutive weeks at a range of doses 10 mg/kg.
In Vivo Model	Neuroblastoma PDX model (PDX: ALK F1245C)
Experiment 8 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 86.39% (Day 15)	Positive ALK expression (ALK+++/++)
Method Description	The in vivo efficacy of CDX-0125-TEI was evaluated in female CB17 SCID mice bearing COG-N-424x (ALK wild-type). Upon enrollment, mice (n = 10 per group) were intraperitoneally injected with 15 mg/kg CDX-0125-TE on day 0 of enrollment and on day 7.
In Vivo Model	Neuroblastoma PDX model (PDX: COG-N-424x)

Experiment 1 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 11.43% (Day 11)	Positive ALK expression (ALK+++/++)
Method Description	The in vivo efficacy of CDX-0125-TEI was evaluated in female CB17 SCID mice bearing NBL-S cells (ALK wild-type). Upon enrollment, mice (n = 10 per group) were intraperitoneally injected with 15 mg/kg CDX-0125-TE on day 0 of enrollment and on day 7.
In Vivo Model	NBL-S CDX model
In Vitro Model	Neuroblastoma	NBL-S cells		CVCL_2136
Experiment 2 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 89.71% (Day 11)	Positive ALK expression (ALK+++/++)
Method Description	The in vivo efficacy of CDX-0125-TEI was evaluated in female CB17 SCID mice bearing NBL-S cells (ALK wild-type). Upon enrollment, mice (n = 10 per group) were intraperitoneally injected with 15 mg/kg CDX-0125-TE on day 0 of enrollment and on day 7.
In Vivo Model	NBL-S CDX model
In Vitro Model	Neuroblastoma	NBL-S cells		CVCL_2136

Experiment 1 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	4.70 pM	Positive ALK expression (ALK+++/++)
Method Description	Cells were seeded at 2000 cells per well in black 96-well proliferation plates and dosed with a titration of conjugates for 3 to 5 days, until control untreated cells reached 80 to 90% confluence.
In Vitro Model	Neuroblastoma	IMR-32 cells		CVCL_0346
Experiment 2 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	5.80 pM	Positive ALK expression (ALK+++/++)
Method Description	Cells were seeded at 2000 cells per well in black 96-well proliferation plates and dosed with a titration of conjugates for 3 to 5 days, until control untreated cells reached 80 to 90% confluence.
In Vitro Model	Buccal mucosa squamous cell carcinoma	NB-1 cells		CVCL_GZ01
Experiment 3 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	21.70 pM	Moderate ALK expression (ALK++)
Method Description	Cells were seeded at 2000 cells per well in black 96-well proliferation plates and dosed with a titration of conjugates for 3 to 5 days, until control untreated cells reached 80 to 90% confluence.
In Vitro Model	Neuroblastoma	SK-N-SH cells		CVCL_0531
Experiment 4 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 1000 pM	Negative ALK expression (ALK-)
Method Description	Cells were seeded at 2000 cells per well in black 96-well proliferation plates and dosed with a titration of conjugates for 3 to 5 days, until control untreated cells reached 80 to 90% confluence.
In Vitro Model	Neuroblastoma	SK-N-AS cells		CVCL_1700

Ref 1	An antibody-drug conjugate directed to the ALK receptor demonstrates efficacy in preclinical models of neuroblastoma. Sci Transl Med. 2019 Mar 13;11(483):eaau9732. doi: 10.1126/scitranslmed.aau9732.