PDS Biotechnology, a portfolio company of NetScientific PLC (AIM:NSCI), has announced an update on its clinical strategy alongside its full-year financial results for 2023.
PDS's approach was to combine PDS01ADC with Versamune, which demonstrated a three-year survival rate of 75% and an overall response rate of 75% in a trial for advanced head and neck cancer.
Based on these promising results, the company will concentrate its late-stage clinical strategy on a triple combination therapy of PDS01ADC, PDS0101 (Versamune HPV), and Merck immunotherapy, KEYTRUDA, for treating advanced head and neck cancer.
This groundbreaking strategy emerged following a successful meeting with the Food and Drug Administration (FDA), where PDS Biotech received guidance on trial design and the regulatory pathway for a pivotal randomised trial.
The trial will focus on the triple combination therapy in recurrent metastatic human papillomavirus (HPV)-positive head and neck squamous cell carcinoma (HNSCC), a type of cancer that affects the mouth, nose, and throat areas, often associated with HPV infections.
PDS chief executive, Frank Bedu-Addo, said: "We have obtained compelling data from several phase II trials in the fourth quarter of 2023, including long-term survival data from the National Cancer Institute (NCI)-led triple combination trial of PDS01ADC in combination with Versamune HPV (PDS0101) and an investigational immune checkpoint inhibitor (ICI), as well as our VERSATILE-002 study.
"We now have a better understanding of how our drug platform technology works in advanced cancer, and we have therefore made the strategic, data-driven decision to add our novel, investigational IL-12 fused antibody-drug conjugate, PDS01ADC, to the promising combination of Versamune HPV and KEYTRUDA to advance the triple combination as our top clinical development priority."