PDS Biotech VERSATILE-002 Phase 2 Clinical Trial Meets Primary Study Endpoints in First Line Recurrent/Metastatic HPV16-Positive Head and Neck Cancer

30 month median overall survival (OS); median OS independent of patient CPS score

ORR 34% (CPS≥1); 48% (CPS≥20)

Phase 3 registrational trial planned to initiate in 2024

PRINCETON, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, 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. A replay of the event can be found here.

• 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.