Preclinical Characterization of Efficacy and Pharmacodynamic Properties of Finotonlimab, a Humanized Anti-PD-1 Monoclonal Antibody

Preclinical Characterization of Efficacy and Pharmacodynamic Properties of Finotonlimab, a Humanized Anti-PD-1 Monoclonal Antibody

<b>Background/Objectives:</b> Finotonlimab (SCTI10A) is a humanized anti-PD-1 antibody tested in Phase III trials for several solid tumor types. <b>Methods</b>: This study characterized the in vitro and in vivo efficacy, Fc-mediated effector function, and non-clinical PK/PD p...

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Main Authors: Yunqi Yao, Xiaoning Yang, Jing Li, Erhong Guo, Huiyu Wang, Chunyun Sun, Zhangyong Hong, Xiao Zhang, Jilei Jia, Rui Wang, Juan Ma, Yaqi Dai, Mingjing Deng, Chulin Yu, Lingling Sun, Liangzhi Xie
Format: Article
Language:English
Published: MDPI AG 2025-03-01
Series:Pharmaceuticals
Subjects:
finotonlimab
anti-PD-1 antibody
preclinical
characterization
pharmacodynamics
Online Access:https://www.mdpi.com/1424-8247/18/3/395
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Summary:<b>Background/Objectives:</b> Finotonlimab (SCTI10A) is a humanized anti-PD-1 antibody tested in Phase III trials for several solid tumor types. <b>Methods</b>: This study characterized the in vitro and in vivo efficacy, Fc-mediated effector function, and non-clinical PK/PD properties of finotonlimab. <b>Results</b>: The results demonstrated that finotonlimab is effective in stimulating human T cell function in vitro and exhibits marked antitumor efficacy in vivo using both PD-1-humanized and PBMC-reconstructed mouse models. Additionally, finotonlimab exhibited minimal impact on the activation of effector cells via Fc receptor-dependent pathways, potentially facilitating PD-1<sup>+</sup> T cell killing. In cynomolgus monkeys, finotonlimab exhibited a nonlinear pharmacokinetic (PK) profile in a dose-dependent manner, and a receptor occupancy rate of approximately 90% was observed at 168 h following a single administration of 1 mg/kg. Finotonlimab’s PK profile (especially C<sub>max</sub>) was better than that of marketed antibodies. Following a 13-week successive administration of finotonlimab, a pharmacodynamic analysis revealed that a sustained mean receptor occupancy of PD-1 molecules on circulating T cells remained at or above 93% for up to 8 weeks, even at a dose of 3 mg/kg, and that there were higher antibody accumulations in different dose groups. <b>Conclusions</b>: Taken together, the preclinical findings are promising and provide the groundwork for evaluating the efficacy and pharmacodynamic characteristics of finotonlimab in clinical trials.
ISSN:1424-8247

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