NetScientific PLC (AIM:NSCI) announced that its portfolio company, PDS Biotechnology, has aligned with the US Food & Drug Administration on its phase III clinical trial of its drug to treat HPV16-positive head and neck cancer.
The trial will assess PDS's Versamune-based immunotherapy platform in combination with pembrolizumab and also a triple combination therapy.
The FDA supported the trial's design, requested additional safety analysis, and agreed to proceed with the double combination trial (VERSATILE-003). Versamune with pembrolizumab has received fast track designation. Dose optimisation will be done separately.
PDS CEO Frank Bedu-Addo said: "We appreciate the FDA's support in the development of both the double and triple Versamune HPV-based combinations. We are also pleased to have aligned on initiating the updated VERSATILE-003 study."
NetScientific holds a 3% stake in PDS Biotechnology.