PDS Biotech Updates on VERSATILE-002 Phase 2 Head and Neck Cancer Trial

PDS Biotechnology Corporation, a late-stage immunotherapy company, has released new data from its VERSATILE-002 Phase 2 clinical trial. This study is focused on evaluating the combination of Versamune® HPV and pembrolizumab (KEYTRUDA®) in patients with HPV16-positive head and neck squamous cell carcinoma (HNSCC). The recent data update, based on a cut-off date of May 17, 2024, provides significant insights into the survival outcomes for patients who have not previously been treated with immune checkpoint inhibitors (ICIs).

The Kaplan-Meier analysis in the ongoing VERSATILE-002 trial includes data from 53 enrolled ICI-naïve patients. As of the latest follow-up, the median overall survival (mOS) remains at 30 months, consistent with earlier data presented in May 2024. Specifically, 27 patients continue to live and await further clinical assessment, while 18 patients have died. Additionally, six patients have withdrawn consent for further follow-up, and two patients have been lost to follow-up. The 95% confidence interval for mOS is between 19.7 months and an upper limit that has not yet been determined, given that most patients are still being monitored for survival.

Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, highlighted the challenging landscape of treating recurrent and/or metastatic HNSCC, where the standard of care typically results in survival rates of less than 18 months. He underscored the importance of the VERSATILE-002 trial in providing critical data to design the primary endpoint for an upcoming Phase 3 trial.

PDS Biotechnology is advancing a three-arm registrational trial for the first-line treatment of HPV16-positive recurrent/metastatic HNSCC. This planned trial will include two active arms: one with the Versamune® HPV and pembrolizumab combination and another with Versamune® HPV, PDS01ADC, and pembrolizumab. PDS01ADC is a tumor-targeted IL-12-fused antibody-drug conjugate that has shown promise in ongoing Phase 2 trials, including one under the National Cancer Institute's oversight.

PDS Biotech is committed to transforming cancer treatment and infectious disease vaccine development through its innovative immunotherapy approaches. The company is preparing to launch a pivotal clinical trial in 2024 to further its lead program targeting advanced head and neck squamous cell cancers. This program combines the IL-12 fused ADC PDS01ADC with the T-cell activator Versamune® HPV in a regimen that includes a standard immune checkpoint inhibitor.

The company believes that its dual-acting combination therapy can effectively disrupt a tumor's internal defenses while generating potent, targeted killer T-cells to attack the tumor externally. Data from clinical trials involving more than 350 patients across various tumor types and treatment regimens have supported the potential broad utility of PDS Biotech's platforms.

Overall, PDS Biotechnology is making significant strides in the immunotherapy field, with promising survival data from its VERSATILE-002 trial bolstering its clinical strategy for future treatment of HPV16-positive cancers.