PDS Biotechnology to prioritize triple combination in place of VERSATILE-003

PDS Biotechnology announced an update to its clinical development strategy and reported its financial results for the year ended December 31, 2023. “We have obtained compelling data from several Phase 2 trials in the fourth quarter of 2023, including long-tem survival data from the National Cancer Institute-led triple combination trial of PDS01ADC in combination with Versamune HPV and an investigational immune checkpoint inhibitor, as well as our VERSATILE-002 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “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. By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV+ head and neck squamous cell cancer, we strongly believe this approach may rapidly establish our proprietary combination of PDS01ADC and Versamune HPV as a transformative oncology treatment. The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. It may also significantly increase the rates of durable tumor shrinkage or overall responses. We are grateful to the patients and physicians who participated in the clinical trials which have helped inform our understanding of how the drug therapies may be used most effectively to safely address advanced cancer, and our decision to prioritize the triple combination.” With the recent long-term survival Phase 2 data from the NCI-led triple combination trial, together with favorable safety and extended survival results seen in both ICI naive and resistant patients in our VERSATILE-002 trial, PDS Biotech has decided to prioritize the triple combination in place of the VERSATILE-003 trial. This decision enables PDS Biotech to focus its resources on the drug regimen it believes has the highest potential to benefit patients with HNSCC and to drive shareholder value.