Drug intelligence / Profile preview

sonidegib + cemiplimab

Development stage
Phase 2
Lead developer
Regeneron Pharmaceuticals
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

**Sonidegib + cemiplimab** is an investigational combination therapy comprised of an oral Hedgehog pathway inhibitor (sonidegib) and an intravenous immune checkpoint inhibitor (cemiplimab)[1][7][3]. Sonidegib selectively inhibits the Smoothened (SMO) receptor, blocking Hedgehog signaling, a driver of basal cell carcinoma pathogenesis. Cemiplimab is a fully human monoclonal IgG4 antibody targeting the Programmed Cell Death Protein 1 (PD-1) receptor on T cells, thus blocking the interaction with PD-L1/PD-L2 ligands and releasing downregulated immune responses against tumor cells[3]. This combination is being evaluated in clinical trials for patients with unresectable, locally advanced, or metastatic basal cell carcinoma, cutaneous squamous cell carcinoma, or synchronous presentations of both, aiming to exploit potential synergism between targeted pathway inhibition and immune checkpoint blockade[1][7].

Other names
sonidegib + cemiplimabOdomzo + Libtayo
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)SMO (Smoothened)

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