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PDS Biotech Announces Final Topline Survival Data from VERSATILE-002 Phase 2 Trial in Head and Neck Cancer

PDS Biotechnology Corporation (PDSB) | August 25, 2025

By Olivia Collins

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PDS Biotech announced final topline survival data from the VERSATILE-002 Phase 2 clinical trial.

The median overall survival (mOS) was 39.3 months in patients with CPS \\(\geq 1\\\), showcasing promising outcomes.

Durable patient survival was linked to the generation of high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101.

Survival Outcome

mOS of 39.3 months in patients with CPS \\(\geq 1\\\), demonstrating potential clinical impact.

Immunotherapy Advances

PDS0101 shows promise in treating HPV16-positive head and neck cancer with notable survival benefits.

Leadership Positioning

PDS Biotech positioned for leadership in the rapidly growing segment of HPV16-positive head and neck squamous cell cancer.

Trial Details

VERSATILE-002 Phase 2 trial assessed PDS0101 efficacy in combination with pembrolizumab for unresectable HPV16-positive HNSCC patients.

Targeted Therapy Need

Urgent need for targeted therapies in HPV16-positive HNSCC, highlighting the potential of PDS0101 in addressing this unmet medical need.

  • PDS0101 in combination with pembrolizumab demonstrates durable and promising survival outcomes in treating HPV16-positive head and neck cancer.
  • The results position PDS Biotech as a key player in addressing the significant unmet medical need in HPV16-positive HNSCC.
  • The VERSATILE-002 trial's success highlights the potential of targeted immunotherapies in transforming cancer treatment approaches.

The final survival data from the VERSATILE-002 trial reinforces the potential of PDS0101 in improving patient outcomes in HPV16-positive head and neck cancer. PDS Biotech's innovative approach signifies a step forward in addressing the urgent need for effective targeted therapies in this rapidly growing segment of cancer patients.