Drug intelligence / Profile preview

mRNA-4650

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

Overview

mRNA-4650 is a personalized, investigational cancer vaccine based on messenger RNA (mRNA) technology. Developed by Moderna in collaboration with the National Cancer Institute (NCI), it is designed to encode up to 15–20 tumor-associated antigens (TAAs) and neoantigens that are specifically expressed by an individual patient's cancer cells[1][2][3][6]. The vaccine's mechanism involves delivering synthetic mRNAs encoding these selected antigens into antigen-presenting cells, which then express the encoded peptides and present them via MHC molecules. This process stimulates both cytotoxic and memory T-cell responses targeting the patient’s unique tumor mutations, aiming to induce a robust anti-tumor immune response[1][3][6]. Clinical trials have shown that mRNA-4650 can elicit neoantigen-specific CD8+ and CD4+ T cell responses with an acceptable safety profile; no dose-limiting toxicities or serious adverse events related to the drug have been reported so far[4]. The vaccine is administered intramuscularly in cycles for patients with metastatic epithelial cancers such as melanoma, gastrointestinal, genitourinary, colorectal, liver cancers, among others[2][4].

Other names
mRNA-based personalized cancer vaccine NCI-4650
02

Targets

MAGEA8 (Melanoma-associated antigen 8)pMHC (Peptide-MHC complex family)

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