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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) | Cmax (μg/mL) | AUC0-168h (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 |
AUC0-168h, area under the concentration-time curve from 0 to 168 hours; Cmax, maximum serum concentration observed; CL, total clearance; FAP-IL2v, fibroblast activation protein-α -targeted interleukin 2 variant (IL2v) immunocytokine; hu, humanized; IV, intravenous.
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| [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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