PDS Biotech’s Versamune® HPV Shows Promising Results in HPV16-Positive Cancer

PDS Biotechnology has announced promising new data on its lead immunotherapy candidate, Versamune® HPV, published in Clinical Cancer Research. The study showed that the treatment significantly accelerated the clearance of HPV16-positive tumor DNA from the bloodstream in patients with locally advanced cervical cancer. This early elimination of circulating tumor DNA (ctDNA) was linked to improved survival and lower cancer recurrence, reinforcing the potential of Versamune® HPV as a groundbreaking treatment. Encouraged by these findings, PDS Biotech is preparing to launch a Phase 3 trial targeting HPV16-positive head and neck squamous cell carcinoma (HNSCC) in the coming months.

Frank Bedu-Addo, PhD, CEO of PDS Biotech, emphasized the significance of the results, noting that the correlation between ctDNA clearance and survival could pave the way for regulatory discussions, including the potential for Breakthrough Therapy designation. The trial demonstrated that 100% of patients receiving Versamune® HPV plus chemoradiation had undetectable ctDNA at follow-up, compared to only 50% in the control group. These compelling findings not only support the further clinical development of Versamune® HPV but also highlight its potential to improve outcomes for patients battling HPV-related cancers.