PDS Biotechnology Corporation (PDSB) has reaffirmed its guidance for the first quarter initiation of the VERSATILE-003 Phase 3 clinical trial. This trial will investigate the efficacy of Versamune® HPV in combination with pembrolizumab for the first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell carcinoma (HNSCC).
The FDA has cleared the amended trial design, allowing PDS Biotech to proceed with the study. The first site initiation is expected in Q1 2025.
VERSATILE-003 Trial Design
The VERSATILE-003 trial is designed to evaluate the combination of Versamune® HPV, a T-cell activating immunotherapy, with pembrolizumab, a PD-1 inhibitor, in patients with R/M HNSCC who are positive for HPV16. This patient population often faces limited treatment options and poor prognosis, highlighting the unmet medical need that this trial aims to address.
Background on Versamune® HPV
Versamune® HPV is PDS Biotech's lead product candidate. It is designed to stimulate a robust T-cell response against HPV16-positive cancer cells. The combination with pembrolizumab is intended to enhance the anti-tumor immune response, potentially leading to improved clinical outcomes.
Previous Clinical Data
Updated results from the VERSATILE-002 Phase 2 clinical trial were presented at ESMO 2024, demonstrating a median overall survival of 30 months, an objective response rate of 36%, and a disease control rate of 77%. Notably, 21% of patients experienced 90-100% tumor shrinkage. These data support the rationale for advancing Versamune® HPV into a Phase 3 trial.
IMMUNOCERV Trial Results
Data from the IMMUNOCERV Phase 2 clinical trial, presented at ASTRO Annual Meeting 2024, showed a 36-month overall survival rate of 84.4% in locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiation. Furthermore, 100% 36-month overall survival (OS) and progression-free survival (PFS) rates were observed in patients fully treated with Versamune® HPV combined with chemoradiation (N=8), and 88% (15/17) of patients had a complete metabolic response.
PDS01ADC + Xtandi® Trial
PDS Biotech also announced the presentation of the rationale and design of a first recurrent prostate cancer trial to combine an Androgen Receptor Pathway Inhibitor with an Immunocytokine. The study will evaluate PDS01ADC + Xtandi® (Enzalutamide) versus Xtandi® alone.
