Drug intelligence / Profile preview

pBI-11 + TA-HPV + pembrolizumab

Development stage
Approved
Lead developer
Vanderbilt-Ingram Cancer Center
Modality
DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Viral Vector Vaccines → Recombinant Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intramuscular, Intravenous
01

Overview

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.

Brand names
Keytruda
Other names
DNA vaccine-Michael K. Gibson-oropharyngeal cancerpBI-11 and TA-HPV with PembrolizumabpBI11 and TA-HPV with PembrolizumabpBI 11 and TA-HPV with Pembrolizumab
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)Human papillomavirus type 16 and 18 E6 and E7 oncoproteinsHsp70 (70 kDa heat shock protein)

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