Drug intelligence / Profile preview

PDS0101

Development stage
Phase 2
Lead developer
PDS Biotech
Modality
Nanoparticles → Drug Delivery Systems, Peptides, Vaccines & Immunotherapeutics
Administration
Subcutaneous
01

Overview

**PDS0101** is an investigational HPV16-targeted therapeutic cancer vaccine developed by PDS Biotechnology. It comprises six HPV16 E6 and E7 peptide antigens formulated with the cationic lipid nanoparticle R-DOTAP, which promotes antigen uptake and cross-presentation by antigen-presenting cells to induce HPV16-specific CD4-positive and cytotoxic CD8-positive T-cell responses against tumor cells expressing the E6 and E7 oncoproteins. It is administered subcutaneously and is in pivotal Phase 3 development with pembrolizumab for first-line recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma; it is also being evaluated in Phase 2 studies across other HPV-associated cancers. ([cancer.gov](https://www.cancer.gov/publications/dictionaries/cancer-drug/def/liposomal-hpv-16-e6-e7-multipeptide-vaccine-pds0101))

Brand names
Versamune HPV
Other names
immunoMAPK-RDOTAP / HPV-16 E6/E7 peptide antigen vaccineliposomal HPV-16 E6/E7 multipeptide vaccine
02

Targets

HPV16 L2CD4 (T lymphocyte surface antigen)

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