Drug intelligence / Profile preview

mRNA-4359

Development stage
Phase 2
Lead developer
Moderna
Modality
mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Vaccines & Immunotherapeutics, Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
Administration
Intramuscular
01

Overview

mRNA-4359 is an investigational mRNA-based cancer vaccine developed by Moderna for the treatment of advanced solid tumors. It encodes instructions for the production of two proteins—indoleamine 2,3-dioxygenase (IDO1) and programmed cell death ligand 1 (PD-L1)—which are involved in immune regulation and tumor immune evasion. Delivered via lipid nanoparticles, mRNA-4359 aims to stimulate the immune system to recognize and attack cancer cells expressing these targets. The drug is being evaluated both as a monotherapy and in combination with pembrolizumab (an anti-PD-1 antibody) in Phase 1/2 clinical trials for various advanced solid tumors, including melanoma, non-small cell lung carcinoma, bladder cancer, head and neck squamous cell carcinoma, microsatellite stable colorectal cancer, basal cell carcinoma, and triple negative breast cancer[1][3][5][7].

Other names
mrna-derived ido/pd-l1-targeted vaccine
02

Targets

IDO1 (Indoleamine 2,3-dioxygenase 1)CD274 (Programmed cell death protein 1 ligand 1)

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