PDS Biotechnology Announces Achievement of Efficacy Threshold in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 and KEYTRUDA® in Head and Neck Cancer

PDS Biotechnology has achieved the efficacy threshold in Stage 2 of the VERSATILE-002 trial with PDS0101 and KEYTRUDA® for head and neck cancer. The trial evaluates PDS0101, an HPV-targeted immunotherapy, combined with Merck’s anti-PD-1 therapy for the treatment of unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer. Fourteen patients in the immune checkpoint inhibitor-naïve arm have experienced either a complete response or partial response on two consecutive scans, thus constituting a confirmed objective response. Additional patients are still being monitored for efficacy and safety.

Clinical-stage immunotherapy company PDS Biotechnology has announced that it has achieved the efficacy threshold in Stage 2 of its VERSATILE-002 clinical trial evaluating PDS0101, an HPV-targeted immunotherapy, combined with Merck's anti-PD-1 therapy KEYTRUDA®, for treating unresectable, recurrent or metastatic HPV16-positive head and neck cancer. Fourteen patients in the immune checkpoint inhibitor-naïve arm experienced either a complete or partial response on two consecutive scans to constitute a confirmed objective response