PDS0101 is an investigational HPV-targeted immunotherapy from PDS Biotech, administered subcutaneously in combination with other cancer therapies. It is designed to induce targeted anti-tumor T-cell responses in HPV-positive cancers. Company pipeline information describes ongoing multi-study Phase 2 evaluation across HPV-associated tumor types.
PDS Biotechnology will report 2025 financial results and provide clinical updates on March 30, 2026. The company faces critical regulatory decisions for its Phase 3 VERSATILE-003 trial in HPV16-positive head and neck cancer and is expanding its immunotherapy platform to prostate cancer and other solid tumors.
PDS Biotechnology adopted an amended protocol for its Phase 3 VERSATILE-003 trial, adding progression-free survival as an interim primary endpoint to support potential accelerated approval of PDS0101 in HPV16-positive head and neck cancer.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07090174 |
Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV |
NOT_YET_RECRUITING | PHASE2 |
| NCT04287868 |
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
