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BNT164b1

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

Overview

BNT164b1 is an investigational mRNA-based vaccine candidate developed for the prevention of tuberculosis. It is part of the BNT164 program and is designed to encode multiple *Mycobacterium tuberculosis* (Mtb) antigens to establish protection by targeting antigens expressed by Mtb in different environments and stages. The vaccine aims to elicit diverse immune effector functions, including both humoral and cellular immune responses, with epitopes intended to stimulate CD4+ and CD8+ T-cell responses across a range of human leukocyte antigen (HLA) types. The mechanism of action involves immunostimulation via mRNA delivery encoding Mtb antigens, leading to activation of the host immune system against tuberculosis. Developed using lipid nanoparticle technology for intramuscular administration, it is currently being evaluated in Phase 1/2 clinical trials as a prophylactic vaccine in healthy adults previously vaccinated with Bacillus Calmette-Guérin (BCG). It is being developed by BioNTech.

Other names
RNA-based tuberculosis vaccine 2BNT164bBNT-164bBNT 164b

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