PDS Biotech begins phase 3 trial for HPV cancer therapy

PRINCETON, N.J. - PDS Biotechnology Corporation (NASDAQ:PDSB), an immunotherapy company with a market capitalization of $50 million, has announced the initiation of a Phase 3 clinical trial named VERSATILE-003, targeting HPV16-positive head and neck cancer. The company is now enrolling patients for this global, multi-center study. According to InvestingPro data, PDSB’s stock has experienced significant volatility, declining nearly 77% over the past year, though current analysis suggests the stock may be undervalued.

The trial aims to evaluate the safety and efficacy of the company’s proprietary immunotherapy, Versamune® HPV, in combination with pembrolizumab, compared to pembrolizumab alone in patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). Approximately 350 patients will be randomized into the trial at a 2:1 ratio, favoring the investigational arm. InvestingPro analysis reveals that while the company holds more cash than debt on its balance sheet, it’s currently burning through cash rapidly, with analysts not anticipating profitability this year.

Dr. Katharine Price of the Mayo Clinic Comprehensive Cancer Center will lead the trial as the Principal Investigator. The primary measure of the study’s success will be overall survival rates, with secondary endpoints including objective response rate, progression-free survival, disease control rate, and duration of response.

Versamune® HPV is a T cell stimulating immunotherapy that has previously shown potential in stimulating high levels of HPV16-specific CD8+ and CD4+ T cells. The U.S. Food and Drug Administration granted the treatment Fast Track designation after promising results from the VERSATILE-002 Phase 2 trial.

Dr. Frank Bedu-Addo, President and CEO of PDS Biotech, expressed confidence in the combination therapy’s potential to improve patient outcomes and set a new standard of care. Dr. Kirk Shepard, Chief Medical Officer, also conveyed optimism regarding the immunotherapy’s ability to enhance immune response and provide significant clinical benefits.

This move into Phase 3 represents a critical step for PDS Biotech in its mission to advance treatment options for patients with advanced HPV16-positive HNSCC. The trial’s results are highly anticipated, with the potential to significantly impact the treatment landscape for this patient population. With a current ratio of 2.84 and liquid assets exceeding short-term obligations, the company appears positioned to support its clinical development programs. Discover more comprehensive insights about PDSB and 1,400+ other stocks through detailed Pro Research Reports available on InvestingPro.

The information in this article is based on a press release statement from PDS Biotechnology Corporation.

In other recent news, PDS Biotechnology Corporation has announced a registered direct offering totaling approximately $11 million with healthcare-focused institutional investors and certain company directors. The offering involves the sale of over 7.3 million shares and warrants, with an exercise price of $1.50 per share, and is expected to close around February 28, 2025. PDS Biotech plans to use the proceeds for research and development expenses and general corporate purposes, particularly as it prepares for a pivotal clinical trial targeting advanced HPV16-positive head and neck cancers. Additionally, the company has received FDA approval for its VERSATILE-003 Phase 3 clinical trial design. This trial will evaluate Versamune® HPV in combination with pembrolizumab for treating recurrent and/or metastatic HPV16-positive head and neck squamous cell cancer. The trial has been granted Fast Track designation to expedite review. Dr. Frank Bedu-Addo, President and CEO of PDS Biotech, expressed readiness for the trial, highlighting its potential to improve patient outcomes. The company also plans to use a companion diagnostic test to confirm HPV16-positive status in patients, marking its first investigational use in a Phase 3 trial.

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