PDS Biotech Initiates Phase 3 HPV Therapy Trial, Reports Q1 2025 Results

PDS Biotechnology Corporation has initiated a Phase 3 clinical trial for its Versamune® HPV therapy targeting recurrent/metastatic HPV16-positive head and neck squamous carcinoma, with the Mayo Clinic joining as a trial site. The FDA has granted Fast Track designation to the combination of Versamune® HPV and pembrolizumab for this indication. Additionally, PDS Biotech received FDA clearance for an IND application to test a combination therapy involving Versamune® MUC1 and PDS01ADC in metastatic colorectal carcinoma, with the National Cancer Institute leading the trial. The company also shared promising preclinical data on its universal flu vaccine candidate, Infectimune®, at the IMMUNOLOGY2025™ Annual Meeting. Financially, PDS Biotech reported a net loss of $8.5 million for Q1 2025, an improvement from the previous year, and recently raised approximately $11 million through a securities offering with potential for additional funding. Several abstracts on their therapies will be presented at the upcoming ASCO Annual Meeting, underscoring ongoing research progress.