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Highlights:
- Optimized Phase 3 Trial Design: PDS Biotech revises VERSATILE-003 trial for cost and timeline efficiency, seeking FDA clearance.
- Promising Clinical Data: Versamune® HPV shows strong safety and efficacy in ongoing studies, including cervical cancer treatment.
- Portfolio Stake for EMV Capital: EMV Capital holds a 2.8% direct stake in PDS Biotech, highlighting its interest in the company’s pipeline progress.
EMV Capital (LSE:EMVC) has reported encouraging progress from its portfolio company, PDS Biotechnology, as part of its third-quarter update. PDS Biotech, focused on innovative immunotherapies, announced key advancements in its clinical trials, including the VERSATILE-003 Phase 3 study and ongoing evaluations of its Versamune® HPV platform.
Revised VERSATILE-003 Trial to Cut Costs and Accelerate Completion
PDS Biotech’s CEO, Frank Bedu-Addo, provided updates on the VERSATILE-003 Phase 3 trial, a study designed to evaluate the combination of Versamune® HPV and pembrolizumab against pembrolizumab alone for first-line treatment of recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).
"Following consultations with investors and input from leading clinicians, we have refined the VERSATILE-003 trial design to streamline costs and expedite data collection," Bedu-Addo stated. The modifications are aimed at reducing overall expenses and shortening the time to achieve an interim data readout.
The company recently submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), with a decision expected by mid-December. If approved, PDS Biotech plans to initiate site activation in the first quarter of 2025.
Promising Data from IMMUNOCERV Phase 2 Trial
In addition to the VERSATILE-003 update, PDS Biotech presented positive data from its IMMUNOCERV Phase 2 trial at the American Society for Radiation Oncology (ASTRO) annual meeting. This study evaluates the use of Versamune® HPV in combination with chemoradiation for treating locally advanced cervical cancer.
The results demonstrated strong clinical activity with a compelling safety profile, reinforcing the potential of Versamune® HPV to enhance treatment outcomes across various HPV-related cancers. Bedu-Addo noted that continued research by PDS Biotech and independent investigators has shown the platform’s versatility in combining effectively with other therapeutic agents to improve patient survival while maintaining low toxicity.
EMV Capital’s Stake in PDS Biotech
EMV Capital, listed on AIM, holds a 2.8% direct equity stake in PDS Biotechnology, underscoring its interest in the company’s innovative pipeline. The progress reported by PDS Biotech aligns with EMV Capital’s strategy of investing in high-growth, cutting-edge healthcare companies.
"We look forward to seeing the advancements made by PDS Biotech as they continue to push the boundaries of cancer immunotherapy," EMV Capital stated in its update, signaling confidence in the ongoing development of PDS Biotech’s clinical programs.
Looking Ahead
PDS Biotech’s updates reflect a strategic pivot to optimize its clinical trials and leverage positive early-phase data. As the company moves closer to obtaining FDA clearance for its Phase 3 study and continues to explore new therapeutic applications of its Versamune® HPV platform, investors and stakeholders are closely watching its progress. The streamlined trial design, coupled with strong preliminary results, sets a promising stage for PDS Biotech’s future developments in the oncology space.
