Gold bars to be exempt from tariffs, White House clarifies
PRINCETON, N.J. - PDS Biotechnology Corporation (NASDAQ:PDSB), a late-stage immunotherapy company with a market capitalization of $63 million, has announced new data from its ongoing Phase 3 clinical trial for a treatment targeting HPV16-positive head and neck squamous cell carcinoma (HNSCC). According to InvestingPro data, while the company maintains a stronger cash position than debt, it faces challenges with rapid cash burn rates typical of clinical-stage biotech firms. The study results, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, revealed a median overall survival (mOS) of 30.0 months in patients with recurrent/metastatic (1L r/m) HPV16-positive HNSCC.
The trial, named VERSATILE-003, is unique as it exclusively addresses this specific patient population, which represents over 50% of HNSCC cases in the United States. The stakes are particularly high for PDSB, whose stock has experienced a significant decline of over 53% in the past year, though InvestingPro analysis suggests the company may be undervalued at current levels. HPV16-positive HNSCC is considered a distinct and more severe disease compared to HPV-negative HNSCC, with a rapidly growing number of cases and a pressing medical need for targeted therapies.
PDS Biotech’s Versamune® HPV, also known as PDS0101, is the investigational immunotherapy at the center of the study. It aims to stimulate a robust T cell response against tumors expressing HPV16 E6 and E7 proteins. The ongoing trial has reached complete enrollment with 53 patients across 31 sites in the US and Europe, and 22 patients are still being followed for survival outcomes.
The mOS has remained stable at 30.0 months, with the lower limit of the 95% confidence interval for mOS increasing from 18.4 months in 2023 to 23.9 months, indicating the durability of the clinical responses induced by Versamune® HPV. The trial has reported no new safety concerns.
These findings are significant as they compare favorably to previously reported survival rates with pembrolizumab monotherapy and combinations in similar patient populations. Dr. Jared Weiss, Section Chief of Thoracic and Head/Neck Oncology at the University of North Carolina, highlighted the encouraging nature of the mOS results for patients with advanced HPV16-positive HNSCC.
Dr. Kirk Shepard, Chief Medical Officer of PDS Biotech, emphasized the importance of overall survival as the gold standard for oncology approvals. He expressed optimism for the upcoming interim survival data readouts and the final OS results from the Phase 3 study. This optimism appears to be shared by Wall Street analysts, with InvestingPro reporting strong buy recommendations and price targets ranging from $4.50 to $13.00 per share. Subscribers to InvestingPro can access the complete financial health analysis, along with 7 additional ProTips and detailed metrics in the comprehensive Pro Research Report available for PDSB and 1,400+ other US stocks.
The U.S. Food and Drug Administration (FDA) has recommended the development of a companion diagnostic to accurately identify and treat patients with HPV16-positive HNSCC, which is included in the VERSATILE-003 trial.
The information reported here is based on a press release statement from PDS Biotechnology Corporation.
In other recent news, PDS Biotechnology Corporation has reported new data from its Versamune® HPV studies, demonstrating extended survival times in patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma. The Phase 2 trial, VERSATILE-002, indicated a median overall survival of 39.3 months for patients with a Combined Positive Score of 20 or higher, surpassing previous benchmarks set by pembrolizumab alone. The company is currently enrolling patients for a Phase 3 trial, VERSATILE-003, to further evaluate the efficacy of this combination treatment. Additionally, PDS Biotech has announced its first-quarter 2025 financial results, showing a reduced net loss of $8.5 million, down from $10.6 million in the same period the previous year.
The company’s strategic focus on innovative cancer therapies is reflected in decreased research and development expenses, which fell to $5.8 million from $6.7 million. PDS Biotech also maintains a cash balance of $40 million as of March 31, 2025. The company continues to advance its VERSAL-three trial, with data expected to be presented at the 2025 ASCO meeting. The ongoing development of a universal flu vaccine and MUC1-targeted cancer therapy further underscores PDS Biotech’s position in the biotech sector. Analysts from B. Riley Securities have shown optimism about the company’s strategic initiatives and reduced financial losses.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.