PDS Biotech’s Versamune® HPV Shows Promising Results in JAMA Oncology Study

PDS Biotechnology Corporation (Nasdaq: PDSB) has announced compelling clinical results published in JAMA Oncology, showcasing the potential of its Versamune® HPV immunotherapy in treating recurrent/metastatic HPV-associated cancers. The study evaluated a triple combination therapy—Versamune® HPV, PDS01ADC (an IL-12 fused antibody-drug conjugate), and a PD-L1 checkpoint inhibitor—in patients with advanced cancers, including head and neck, cervical, anal, and penile cancers. The findings suggest a notable increase in response rates and survival outcomes, particularly in HPV16-positive patients, when compared to historical standard-of-care treatments.

The study, conducted by the National Cancer Institute (NCI), enrolled 50 patients, revealing an overall response rate (ORR) of 62.5% in HPV16-positive, immune checkpoint blockade (ICB)-naïve patients—significantly higher than the 12-24% response seen with standard therapies. For ICB-resistant patients, those receiving a high dose of PDS01ADC showed an ORR of 62.5%, far exceeding the historical 10% benchmark. With no treatment-related deaths reported and manageable toxicity, PDS Biotech now looks ahead to launching its VERSATILE-003 Phase 3 trial next month, further exploring Versamune® HPV in HPV16-positive head and neck squamous cell carcinoma.