PDS0101 + pembrolizumab

**PDS0101 + pembrolizumab** is a combination regimen comprising two agents: - **PDS0101**: A molecularly targeted immunotherapy formulated as an enantiospecific cationic lipid nanoparticle vaccine, containing synthetic peptides derived from HPV16 E6/E7 neoantigens. It is designed to induce robust, long-lasting, multifunctional HPV16-specific CD8 and CD4 T cell responses by upregulating Type I interferons, enhancing antigen processing and cross-presentation, and reversing immune evasion caused by HPV oncoproteins[1][3][4][6]. - **Pembrolizumab**: An intravenous monoclonal antibody checkpoint inhibitor that blocks PD-1 (programmed cell death protein 1) on T cells, thereby preventing tumor-induced immune suppression and enhancing antitumor T-cell activity. This combination aims to address recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC), leveraging complementary immunologic mechanisms to improve patient survival and tumor response rates. PDS0101 is administered subcutaneously in several cycles combined with regular IV pembrolizumab infusions[1][2][3][4][6].

Brand names

KeytrudaVersamune HPV

Other names

PDS0101 plus pembrolizumabPDS-0101 plus pembrolizumabPDS 0101 plus pembrolizumab