Key Takeaways
- PDS Biotechnology has launched a Phase III trial, VERSATILE-003, to evaluate Versamune HPV combined with pembrolizumab for treating HPV16-positive head and neck cancer.
- The trial aims to enroll approximately 350 participants, focusing on overall survival as the primary endpoint.
- Versamune HPV has received fast track designation from the FDA, potentially expediting its review process for market approval.
Clinical Trial Launch
PDS Biotechnology has initiated the VERSATILE-003 Phase III clinical trial to assess the efficacy and safety of an innovative combination therapy: Versamune HPV and pembrolizumab. This therapy targets patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for HPV16.
The global, multi-centre trial is designed to involve around 350 participants. These subjects will be randomly assigned in a 2-to-1 ratio to either receive the investigational combination of Versamune HPV and pembrolizumab or to the control group receiving only pembrolizumab. The primary endpoint of the trial will be overall survival, while secondary endpoints will focus on progression-free survival, objective response rate, duration of response, and disease control rate.
Dr. Katharine Price, an associate professor at Mayo Clinic Comprehensive Cancer Center’s Oncology, Head and Neck Disease Group, will lead the trial as the principal investigator. Frank Bedu-Addo, CEO and president of PDS Biotechnology, expressed enthusiasm about the trial’s progress, noting that the first trial site has been activated, with plans to open additional sites soon. He commented on the promising outcomes observed in the previous VERSATILE-002 Phase II study and conveyed confidence in the potential of the combination therapy to enhance patient care.
Versamune HPV is a subcutaneous immunotherapy that has shown effectiveness in stimulating significant immune responses, particularly in activating CD8+ and CD4+ T cells, which are crucial for fighting HPV-related tumors. The therapy has received fast track designation from the US Food and Drug Administration (FDA), a status that could facilitate a priority review of its eventual biologics license application (BLA) based on data from the earlier Phase II trial.
Additionally, PDS Biotechnology is working on expanding the application of Versamune HPV beyond its current use with pembrolizumab. The company is exploring its use in a triple-combination therapy approach, incorporating an Interleukin-12 (IL-12)-fused antibody-drug conjugate (ADC) known as PDS01ADC, alongside standard immune checkpoint inhibitors. This innovative strategy aims to maximize therapeutic efficacy in advanced HPV16-positive HNSCC patients.
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