PRINCETON, N.J. - PDS Biotechnology (NASDAQ:PDSB) Corporation (NASDAQ:PDSB), a late-stage immunotherapy company, has released updated data from its VERSATILE-002 Phase 2 clinical trial for the treatment of HPV16-positive head and neck squamous cell cancer (HNSCC). The trial, which is ongoing, evaluates the efficacy of the combination of Versamune® HPV and KEYTRUDA® (pembrolizumab) in patients who have not previously received immune checkpoint inhibitors (ICIs).
According to the Kaplan-Meier analysis, the median overall survival (mOS) for the patient cohort is 30 months, consistent with previous reports. This figure remains unchanged from the data presented on May 9, 2024, and is based on the most recent data cut as of May 17, 2024. The survival data encompasses 53 enrolled patients, with 27 still alive and awaiting further assessment, 18 deceased, 6 who have withdrawn consent, and 2 lost to follow-up. The lower limit of the 95% confidence interval for mOS is 19.7 months, with the upper limit yet to be determined as the majority of patients are still being followed for survival.
Dr. Kirk Shepard, Chief Medical Officer at PDS Biotech, highlighted the significance of the findings, noting that survival rates under current standards of care are generally less than 18 months for recurrent and/or metastatic HNSCC. The company believes the VERSATILE-002 trial, along with a planned triple combination trial, will provide essential survival information to inform the design of a statistical primary endpoint for an upcoming Phase 3 trial.
PDS Biotech is advancing a clinical strategy that includes a three-arm registrational trial for first-line treatment of HPV16-positive recurrent/metastatic HNSCC. The trial will compare the double combination of Versamune® HPV and pembrolizumab with a triple combination that adds PDS01ADC, the company's tumor-targeted IL-12-fused antibody-drug conjugate (ADC), which has shown promise in ongoing Phase 2 trials.
The company's lead program combines PDS01ADC with the T-cell activator Versamune® HPV and a standard-of-care immune checkpoint inhibitor, aiming to disrupt tumor defenses and generate targeted killer T-cells. PDS Biotech expects to announce full data from the May 17, 2024 data cut in Q3 2024 and plans to initiate a pivotal clinical trial in 2024.
In other recent news, PDS Biotechnology Corporation experienced a revision in its share target, with B.Riley adjusting the price from $11 to $9 while retaining a buy rating. This adjustment follows the company's first-quarter results and a comprehensive review of the competitive landscape in immunotherapy treatments for HPV-positive head and neck cancers. PDS Biotechnology also reported a net loss of $42.9 million for the year-end 2023, but confirmed a cash balance sufficient to fund operations until Q4 2025.
The company announced a strategic shift towards a development strategy emphasizing a triplet regimen combining its tumor-activated IL-12 ADC with PDS0101 or Versamune HPV and Keytruda. PDS Biotechnology also appointed Stephan Toutain as Chief Operating Officer, a move that will contribute to the company's strategic vision and operational excellence as they prepare to initiate a pivotal clinical trial for advanced head and neck squamous cell cancers with their lead program in 2024.
These developments are part of a series of recent events that highlight the dynamic nature of the biotech industry and the ongoing efforts of PDS Biotechnology in its clinical strategy and financial management. B.Riley expressed optimism about PDS Biotechnology's registration strategy, particularly the potential for its triplet regimen to replicate the success seen with petosemtamab in the first-line treatment of HPV-positive HNSCC patients.
InvestingPro Insights
As PDS Biotechnology Corporation (NASDAQ:PDSB) continues to make strides in its clinical trials, investors and stakeholders are closely monitoring the company's financial health and market performance. With the latest data from InvestingPro, here are some key insights:
InvestingPro Data:
- PDS Biotech's market capitalization stands at a modest $101.23M, reflecting its status as a late-stage biotech company focused on immunotherapy development.
- The company's Price to Earnings (P/E) ratio is currently negative at -2.05, indicating that it is not generating net income at present—a common scenario for many clinical-stage biotech companies.
- PDS Biotech's stock has experienced significant volatility, with a 1 Week Price Total Return of -8.31%, and a 6 Month Price Total Return of -45.78%, which highlights the stock's recent downward trend in the market.
InvestingPro Tips:
- Two analysts have recently revised their earnings estimates upwards for PDS Biotech, suggesting a potential positive outlook for the company's financial performance in the upcoming period.
- Despite the challenges, PDS Biotech holds more cash than debt on its balance sheet, which may provide some financial flexibility as it continues to fund its clinical trials and research initiatives.
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