PDS Biotechnology has commenced the randomised, multi-centre Phase III clinical trial, VERSATILE-003, to assess the efficacy and safety of Versamune HPV plus pembrolizumab for head and neck squamous cell carcinoma (HNSCC).
The combination therapy is intended for use as a first-line treatment of individuals with recurrent or metastatic HPV16-positive HNSCC.
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According to the company, the open-label, global and controlled trial is structured for enrolling nearly 350 subjects. They will be assigned to either the investigational arm or to a control arm, receiving only pembrolizumab at a 2:1 ratio.
Overall survival is the primary endpoint, with secondary endpoints being progression-free survival, objective response rate, duration of response, and disease control rate.
Mayo Clinic Comprehensive Cancer Center Oncology, Head and Neck Disease Group associate professor Katharine Price is set to oversee the trial as principal investigator.
PDS Biotechnology CEO and president Frank Bedu-Addo said: “We are thrilled to share that the first trial site has been initiated, and activation of additional clinical sites continues.
“Considering the strength and durability of the clinical responses in our VERSATILE-002 study, we are pleased to get this registrational trial underway. We are confident in the potential of our innovative combination therapy to improve patient outcomes and enhance the standard of care.”
Versamune HPV is a subcutaneous immunotherapy that has demonstrated “potential” in stimulating high levels of HPV16-specific cluster of differentiation 8 +(CD8+) and CD4+ T cells, activating several immune pathways.
It received fast track designation from the US Food and Drug Administration (FDA). This status could result in a priority review for the biologics license application (BLA) when submitted.
This decision by the US regulator is supported by data from the multicentre VERSATILE-002 Phase II trial.
The company is advancing its lead programme in advanced HPV16-positive head and neck squamous cell cancers with the pivotal trial.
PDS stated that Versamune HPV is being developed not only in conjunction with a standard-of-care immune checkpoint inhibitor, but also in a triple combo therapy that includes the Interleukin-12 (IL-12) IL-12 fused antibody-drug conjugate (ADC), PDS01ADC, and a standard-of-care immune checkpoint inhibitor.
