Drug intelligence / Profile preview

pexastimogene devacirepvec + cemiplimab

Development stage
Phase 2
Lead developer
SillaJen
Modality
Oncolytic Viruses → Oncolytic Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous, Intratumoral
01

Overview

Combination immunotherapy consisting of **pexastimogene devacirepvec (Pexa-Vec)**, an engineered oncolytic vaccinia virus, and **cemiplimab** (a monoclonal antibody checkpoint inhibitor targeting programmed cell death protein 1 [PD-1]). Pexa-Vec selectively infects and lyses tumor cells, expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) to induce systemic anti-tumor immune responses. Cemiplimab blocks PD-1-mediated immune suppression, restoring T-cell activity against tumors. In clinical studies, this combination has shown an acceptable safety profile, promising overall response rates, and evidence of durable responses in metastatic or unresectable renal cell carcinoma[5][7][9]. The main indications under investigation are metastatic renal cell carcinoma; the drug is being trialed in other solid tumors.

Brand names
Libtayo (cemiplimab)Pexa-Vec (pexastimogene devacirepvec)
Other names
pexastimogene devacirepvecJX-594JX594JX 594Pexa-VeccemiplimabREGN2810REGN-2810REGN 2810Libtayo
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)TK1 (Thymidine kinase 1)GM-CSF (Granulocyte-macrophage colony-stimulating factor)

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