PDS Biotech Announces Positive Clinical Data Demonstrating Compelling Survival and Clinical Responses in Recurrent/Metastatic HPV-Associated Cancers Published in JAMA Oncology

Core Insights - PDS Biotechnology Corporation announced promising clinical results for its immunotherapy, Versamune® HPV, in combination with PDS01ADC and a PD-L1 immune checkpoint inhibitor for treating recurrent/metastatic HPV-associated cancers [1][2][4] Group 1: Clinical Results - The median overall survival (mOS) for immune checkpoint inhibitor (ICI) naïve patients was reported at 42.4 months, significantly higher than the historical range of 7-12 months [1][5] - In HPV16-positive ICI resistant patients, the mOS was 17 months, compared to the historical result of 3-4 months [1][9] - The objective response rate (ORR) for HPV16-positive ICI naïve patients was 75%, while the historical ORR for this group was 11-24% [1][5] Group 2: Trial Details - The clinical trial was a single-center, non-randomized study led by the National Cancer Institute (NCI), involving 50 patients with recurrent/metastatic HPV-positive cancers [2][6] - Among the enrolled patients, 52% were men, with a median age of 56 years, and 37 patients were HPV16-positive [2][6] - The trial evaluated Versamune® HPV at a fixed dose, PDS01ADC at both high (16.8 ug/kg) and low (8.0 ug/kg) doses, and bintrafusp alfa (BA) at high and low doses [3] Group 3: Future Directions - The company plans to initiate the VERSATILE-003 Phase 3 trial of Versamune® HPV combined with pembrolizumab for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma [2][7] - The results support the continued investigation of both Versamune® HPV and PDS01ADC in ongoing and future clinical trials [6][7]