NetScientific PLC's portfolio company, PDS Biotech, has revealed a strategic update and financial results for 2023. The company's focus will be on the triple combination of PDS01ADC, PDS0101 (Versamune® HPV), and KEYTRUDA® in advanced head and neck cancer. The decision is based on compelling data from Phase 2 trials, including long-term survival data from the National Cancer Institute (NCI)-led triple combination trial. The company aims to address the unmet medical need in recurrent metastatic HPV+ head and neck squamous cell cancer (HNSCC) and establish its proprietary combination as a transformative oncology treatment.
The decision to prioritize the triple combination over the VERSATILE-003 trial is supported by favorable safety and extended survival results seen in both ICI naïve and resistant patients in the VERSATILE-002 trial. PDS Biotech is in discussions with the U.S. Food and Drug Administration (FDA) on the design of a potentially pivotal clinical trial to treat HPV+ HNSCC, expected to commence in 2024. The Phase 2 NCI-led triple combination clinical trial data for the treatment of recurrent/metastatic ICI naïve and ICI resistant HPV16-positive cancers, including head and neck, anal, cervical, vaginal, and vulvar cancers, have shown promising results, with 75% of patients remaining alive at 36 months and an overall response rate (ORR) of 75%.
The decision to prioritize the triple combination has been guided by discussions with key opinion leaders in HNSCC, who have highlighted the clear unmet need in HPV+ HNSCC. The company aims to address the growing incidence of advanced HPV+ HNSCC, a devastating, hard-to-treat cancer with no approved HPV-related treatment currently available. The upcoming controlled randomized clinical trial will build upon the current data and is expected to provide further insights into the potential of this unique combination to treat HNSCC.