ChemicalBook CAS DataBase List 1776942-10-9

1776942-10-9

Name	Simlukafusp alfa
CAS	1776942-10-9

Chemical Properties

form	Liquid
color	Colorless to light yellow

Hazard Information

Uses

Simlukafusp alfa (FAP-IL2v) is an immunocytokine comprising an antibody against fibroblast activation protein α (FAPα) and an IL-2 variant that only binds IL-2Rβγ. Isotype: human IgG1[1].

in vivo

Simlukafusp alfa (FAP-IL2v) (1 mg/kg; i.v.; weekly for 4 weeks) is efficacious in combination with therapeutic antibodies in murine models of human cancer^[1].

Animal Model:	huCD16-transgenic SCID mice, lung orthotopic xenograft A549 model^[1]
Dosage:	1 mg/kg in combination with 25 mg/kg Cetuximab (HY-P9905) as single agents
Administration:	IV, weekly starting at Day 14 for 4 weeks
Result:	Achieved greater tumor control than either agent given as monotherapy. Reduced tumor volume and tumor growth.

Animal Model:

CD-1 mice^[1]

Dosage:

1, 2 or 4 mg/kg

Administration:

IV (Pharmacokinetic Analysis)

Result:

Pharmacokinetic parameters after first dose of human FAP-IL2v (huFAP-IL2v) in CD-1 mice
CD-1 mice (n=10 per group) were given 1, 2, and 4 mg/kg huFAP-IL2v by IV administration once weekly. Multiple IV doses at 1 and 2 mg/kg were administered QW for up to a maximum of three doses, at which point toxicity was observed. Only a single dose was administered to the 4-mg/kg IV treatment group because of toxicity in these treatment groups. Blood was sampled at 0.5, 6, 24, 48, 72, and 168 h.

huFAP-IL2v dose (mg/kg)	C_max (μg/mL)	AUC_0-168h (μg?h/mL per mg/kg)	CL (mL/d/kg)
1	19.0	557	40.0
2	36.3	479	46.8
4	78.7	541	38.7

AUC_0-168h, area under the concentration-time curve from 0 to 168 hours; C_max, maximum serum concentration observed; CL, total clearance; FAP-IL2v, fibroblast activation protein-α -targeted interleukin 2 variant (IL2v) immunocytokine; hu, humanized; IV, intravenous.

References

[1] Waldhauer I, et al. Simlukafusp alfa (FAP-IL2v) immunocytokine is a versatile combination partner for cancer immunotherapy. MAbs. 2021 Jan-Dec;13(1):1913791. DOI:10.1080/19420862.2021.1913791

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