Business
PDS: Q4 Results and Clinical Programs Update
PDS: Q4 Results and Clinical Programs Update.
About this update from Emv Capital Plc
[{"type":"text","content":"\n\nFor immediate release\n \nEMV Capital plc\n \n(\"EMVC\" or the \"Company\")\n \nPDS Biotech Reports Full Year 2024 Financial Results and Provides Clinical Programs Update\nInitiated VERSATILE-003 Phase 3 Clinical Trial Evaluating Versamune® HPV in HPV16-Positive Head and Neck Cancer\n \nEMV Capital plc (AIM: EMVC), the deeptech and life sciences VC investment group, reports that its portfolio company PDS Biotechnology Corporation (Nasdaq: PDSB) - a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, and in which it holds a 2.3% direct holding - has provided a clinical programs update and reported financial results for the full year ended December 31, 2024.\n \nFrank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech, said:\n \n\"We are pleased with the progress made over the past year and in recent weeks, culminating with the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating Versamune® HPV in recurrent/metastatic (\"R/M\") HPV16-positive head and neck squamous carcinoma (\"HNSCC\"). Patients with HPV16-positive HNSCC represent a large and rapidly growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. Considering the strength and durability of the clinical responses observed in our VERSATILE-002 study, we are excited that this registrational trial is underway and are confident in the potential of our innovative combination therapy to improve patient outcomes and enhance the standard of care. In the coming weeks, we expect to continue activating additional clinical sites, and look forward to the progression of this registrational trial.\"\n \nClinical Strategy Summary\n· Phase 3 VERSATILE-003 Trial in HPV16-positive first-line recurrent and/or metastatic HNSCC\n· Announced activation of the first site in March 2025\n· Trial designed to include approximately 350 patients\n· PDS Biotech is aligned with the U.S. Food and Drug Administration (\"FDA\") on the design of the registrational trial and clinical endpoints.\n§ Two-arm controlled trial with 2:1 randomisation\n§ Median overall survival is primary endpoint\n§ Design based on strong and dur...