Drug intelligence / Profile preview

VPM1002

Development stage
Phase 3
Lead developer
Serum Institute of India
Modality
DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Administration
Intradermal, Intravesical
01

Overview

VPM1002 is a genetically modified recombinant Bacille Calmette–Guérin (BCG) vaccine derived from Mycobacterium bovis BCG Danish subtype Prague. It is engineered by replacing the urease C gene with the listeriolysin O (LLO) encoding gene from Listeria monocytogenes, resulting in a strain that expresses listeriolysin and is deficient in urease. This modification allows for enhanced phagosome acidification and optimal activity of listeriolysin O, which perforates phagosomal membranes to facilitate the release of mycobacterial antigens into the cytosol. The released antigens trigger autophagy, inflammasome activation (notably AIM2), apoptosis, and improved antigen presentation via MHC I pathways—leading to robust CD4+ and CD8+ T-cell responses[1][2][3][7]. VPM1002 was developed as an improved TB vaccine for newborn immunization and post-exposure prophylaxis in adults to prevent tuberculosis recurrence[4]. It has also been investigated as an immunotherapy for non-muscle invasive bladder cancer after failure of standard BCG therapy[5]. Clinical trials have demonstrated increased safety and immunogenicity compared to conventional BCG vaccines, including in HIV-exposed newborns[6].

Brand names
VPM1002BCVPM-1002BCVPM 1002BC
Other names
recombinant BCG vaccine expressing listeriolysinrBCGΔureC::Hly+recombinant Bacille Calmette–Guérin vaccine

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