Drug intelligence / Profile preview

autogene cevumeran + nivolumab

Development stage
Unknown
Lead developer
BioNTech
Modality
mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Administration
Intravenous, Intramuscular
01

Overview

**Autogene cevumeran + nivolumab** is an investigational combination therapy comprising a personalized, mRNA-based cancer vaccine (autogene cevumeran) and the PD-1 checkpoint inhibitor nivolumab. **Autogene cevumeran** is a uridine mRNA lipoplex vaccine custom-manufactured for each patient, encoding up to 20 neoantigens derived from the individual's tumor mutations, designed to stimulate strong CD4+ and CD8+ T cell responses against the patient’s cancer. **Nivolumab** is a human monoclonal antibody that blocks the PD-1 receptor on T cells, releasing inhibition on immune responses and enhancing anti-tumor activity. The combination is under investigation to increase immunogenicity and improve clinical outcomes versus checkpoint inhibitor alone in cancers such as high-risk muscle-invasive urothelial carcinoma (MIUC) and is being studied in a randomized clinical trial after bladder cancer surgery. Autogene cevumeran is produced using tumor sequencing and computational prediction of neoantigen targets, while nivolumab acts broadly to prevent immune evasion.

Other names
individualized neoantigen-specific mRNA vaccine + nivolumabautogene cevumeran + Opdivo
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)

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