EMV Capital (AIM:EMVC) has noted the clinical progress update from portfolio company PDS Biotechnology alongside its third-quarter update.
Frank Bedu-Addo, PDS chief executive, said: "Since our last update in August, we have been actively engaged with investors and clinicians to discuss our strategy and funding requirements for our VERSATILE-003 Phase 3 trial of Versamune® HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell cancer (HNSCC).
“Based on investor feedback, discussions with key opinion leaders involved with the study and other experts, we have made minor modifications to the VERSATILE-003 trial design to reduce the overall cost and time required to achieve an interim data readout and trial completion."
After submitting an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) this week, PDS Biotech expects the clearance decision by mid-December, allowing PDS Biotech to initiate site activation in the first quarter of 2025.
Bedu-Addo added: "Elsewhere in our pipeline, we were pleased with the data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV with chemoradiation to treat locally advanced cervical cancer presented at the American Society for Radiation Oncology (ASTRO) annual meeting.
"The presented data demonstrated promising clinical activity and a compelling safety profile.
"Based on continued research in various HPV-positive cancers conducted by PDS Biotech and independent researchers who recognize its potential, Versamune® HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with favourable toxicity.”
EMV Capital (AIM:EMVC) has a 2.8% direct holding in PDS Biotech.