PDS Biotechnology Corporation hosted a Key Opinion Leader event on May 8, 2024 during which prominent experts in head and neck squamous cell cancer (?HNSCC?) discussed positive, updated VERSATILE-002 data and the unmet need in HPV16-positive HNSCC. The VERSATILE-002 trial is evaluating Versamune® HPV + KEYTRUDA® (pembrolizumab) in patients with HPV16-positive HNSCC. Median overall survival (?mOS?) is 30 months (n=53) in first line recurrent metastatic HNSCC; Published results for immune checkpoint inhibitors are 7-18 months.

The immune checkpoint inhibitor (ICI) naïve cohort (n=53) met its primary endpoint of best overall response (BOR). BOR by investigator assessment is 34% (Combined Positive Score (CPS) =1; n=18/53); 48% (CPS=20; n=10/21); Published results for ICIs are <20% (CPS>1) and <25% (CPS=20). Progression free survival (?PFS?) is 6.3 months (CPS=1); 14.1 months (CPS=20); Published results for immune checkpoint inhibitors 2-3 months.

VERSATILE-002 data to date indicate a durable response in first line recurrent and /or metastatic HNSCC patients with CPS=1. The combination of Versamune® HPV + pembrolizumab was well tolerated. The Company announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune® HPV + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent metastatic HNSCC. PDS01ADC is the Company?s novel, investigational tumor-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune® HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.

Part one of the clinical trial will focus on dose optimization with a data readout based on safety and objective response rate. The randomized second part of the trial will include an interim data readout with OS as its primary endpoint.