PDS announces preliminary study results of subset of patients in VERSATILE-002

PDS Biotechnology announced immune response data from a preliminary analysis of a subset of patients in VERSATILE-002, the Phase 2 clinical trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA in patients with human papillomavirus 16-positive recurrent or metastatic head and neck squamous cell carcinoma, HNSCC. The data presented during the European Society for Medical Oncology Congress 2023 provided preliminary insight to the pre-existing immune responses in advanced HPV-positive HNSCC patients and potential changes to the immune profile after treatment. “Generation of multifunctional, anti-tumor T cells with the relevant cytokine and chemokine profiles are necessary for effective long-term control of tumor growth and clinical outcomes. This initial study focused on understanding the immunological profile of advanced head and cancer patients in the blood,” said Kevin Harrington, PhD, Professor of Biological Cancer Therapies, The Royal Marsden. “This preliminary study suggests that PDS0101 may promote a TH1 predominant cytokine profile as well as induction of important T cell activating chemokines. Such studies could be helpful in providing further insight into how PDS0101 in combination with KEYTRUDA alters T cell cytokine and chemokine profiles to promote improved clinical outcomes.” Highlights of the analysis include: combination of PDS0101 and KEYTRUDA appears to lead to changes towards a TH1 predominant cytokine profile reported to be associated with improved killer T cell activity; Combination of PDS0101 and KEYTRUDA(R) resulted in increased polyfunctionality reflected in T cells expressing 5 or more cytokines. Increased polyfunctionality is typically associated with enhanced killing function and anti-tumor activity.