Drug intelligence / Profile preview

REGN5668 + cemiplimab + fianlimab

Development stage
Unknown
Lead developer
Regeneron Pharmaceuticals
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

REGN5668 + cemiplimab + fianlimab is an investigational combination regimen evaluated in clinical trials for advanced cancers, notably ovarian and uterine cancer. REGN5668 is a bispecific monoclonal antibody that targets MUC16 (a tumor antigen, also known as CA-125) and CD28 (a co-stimulatory receptor on T cells), thus serving to enhance T-cell activation specifically within the tumor microenvironment. Cemiplimab is a fully human monoclonal antibody that targets the immune checkpoint programmed death-1 (PD-1) receptor, functioning as a checkpoint inhibitor to restore T-cell mediated antitumor immunity. Fianlimab is a monoclonal antibody targeting lymphocyte activation gene-3 (LAG-3), another immune checkpoint that negatively regulates T-cell function. The combination is designed to amplify antitumor immune responses through complementary engagement: costimulation (CD28), blockade of inhibitory PD-1 and LAG-3 pathways. The regimen is under early-phase testing for its safety, tolerability, dose determination, and preliminary antitumor activity in solid tumors, particularly ovarian and uterine cancers[1][3][4][7].

Other names
cemiplimabfianlimab
02

Targets

MUC16 (Mucin-16)CD28 (Cluster of Differentiation 28)PDCD1 (Programmed cell death protein 1 receptor)

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