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pBI-11 + TA-HPV + pembrolizumab is an investigational combination immunotherapy regimen being evaluated for the treatment of HPV-positive, PD-L1-positive recurrent or metastatic oropharyngeal cancer. The regimen employs a heterologous prime-boost vaccination strategy: pBI-11 is a circular DNA plasmid vaccine that primes the immune system, while TA-HPV is a recombinant vaccinia virus vaccine that boosts the response. Both vaccines target the E6 and E7 oncoproteins of HPV types 16 and 18 to stimulate a robust cytotoxic T-cell response against tumor cells. This vaccination approach is combined with pembrolizumab, a monoclonal antibody that inhibits the PD-1/PD-L1 checkpoint pathway, thereby preventing T-cell exhaustion and enhancing the overall anti-tumor efficacy. The therapy is currently being studied in a Phase II clinical trial (NCT05799144) led by Michael K. Gibson at the Vanderbilt-Ingram Cancer Center.
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