Drug intelligence / Profile preview

cemiplimab + ISA101b

Development stage
Unknown
Lead developer
Regeneron Pharmaceuticals
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Administration
Intravenous, Subcutaneous
01

Overview

cemiplimab + ISA101b is an investigational combination therapy comprising **cemiplimab**, a fully human monoclonal antibody targeting PD-1 (Programmed cell death protein 1), and **ISA101b** (peltopepimut-S), a therapeutic peptide vaccine targeting oncogenic E6 and E7 proteins of HPV16. Cemiplimab blocks the PD-1/PD-L1 interaction, thereby enhancing T-cell mediated immune response against cancer cells, while ISA101b induces HPV16-specific CD4+ and CD8+ T-cell responses. The combination aims to provide a synergistic anti-tumor effect, especially for HPV16-positive malignancies, such as oropharyngeal and cervical cancers, including recurrent/metastatic disease and patients resistant to prior PD-1 inhibitor therapies. The combination is under development and has demonstrated clinical benefit, particularly in patients with high PD-L1 expression or high combined positive score (CPS) for PD-L1[1][2][3][5].

Brand names
Libtayo + ISA101b
Other names
peltopepimut-S + cemiplimabcemiplimab + peltopepimut-S
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)HPV16 E6 oncoproteinHPV16 E7 (Human papillomavirus 16 E7 protein)

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