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ITI-5000 TNBC Vaccine + pembrolizumab is an investigational combination therapy being evaluated for the treatment of early-stage triple-negative breast cancer (TNBC). ITI-5000 is a self-amplifying RNA (saRNA) vaccine delivered via lipid nanoparticles (LNPs). It encodes a fusion protein consisting of two tumor-associated antigens, Human Endogenous Retrovirus-K (HERV-K) and Cancer/Testis Antigen 83 (CT83), fused with Lysosomal-Associated Membrane Protein 1 (LAMP-1) to enhance immune presentation. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking monoclonal antibody. The combination aims to stimulate a robust T-cell response against TNBC cells while overcoming immune checkpoint-mediated suppression.
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