PRINCETON, N.J. - PDS Biotechnology (NASDAQ:PDSB) Corporation (NASDAQ:PDSB), a late-stage immunotherapy company, announced a strategic update focusing on a triple combination therapy for advanced head and neck cancer, following positive results from Phase 2 clinical trials. The company will concentrate its late-stage clinical strategy on the combination of PDS01ADC, PDS0101 (Versamune® HPV), and KEYTRUDA® in treating recurrent metastatic HPV-positive head and neck squamous cell cancer (HNSCC).
The decision comes after the National Cancer Institute (NCI)-led trial demonstrated a three-year survival rate of 75% and an overall response rate of 75% with the triple combination therapy. These outcomes suggest a significant improvement over current treatments for HNSCC, a disease with limited effective options, particularly in HPV-positive cases.
PDS Biotech's Chief Executive Officer, Dr. Frank Bedu-Addo, highlighted the data-driven decision to prioritize the triple combination, citing its potential to transform oncology treatment. The company's Chief Medical Officer, Dr. Kirk V. Shepard, acknowledged the clear unmet medical need in this patient population and expressed confidence in the triple combination's ability to address it.
The company reported a net loss for the year ended December 31, 2023, of approximately $42.9 million, with research and development expenses decreasing from the previous year and general and administrative expenses increasing. The cash balance as of December 31, 2023, was $56.6 million.
PDS Biotech plans to initiate a pivotal clinical trial in 2024, building on the positive long-term survival data and the favorable safety profile demonstrated in previous studies. The company has engaged with the FDA for guidance on trial design and regulatory pathways for the upcoming trial.
The company's lead program combines an antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune® HPV with a standard-of-care immune checkpoint inhibitor. This combination has shown promising survival results and tumor shrinkage, indicating tolerability and a potential inside-out mechanism to disrupt tumor defenses and generate targeted killer T-cells.
This article is based on a press release statement from PDS Biotechnology Corporation.
InvestingPro Insights
As PDS Biotechnology Corporation (NASDAQ:PDSB) gears up for pivotal clinical trials in its fight against advanced head and neck cancer, the financial metrics and analyst perspectives from InvestingPro shed light on the company's market position and future prospects.
InvestingPro Data highlights a market capitalization of $139.36 million, reflecting the company's current valuation in the market. Despite a challenging financial performance with an operating income of approximately negative $51.46 million over the last twelve months as of Q3 2023, PDS Biotech holds more cash than debt, which could provide some financial flexibility as it advances its clinical programs. The company's stock has experienced volatility, with a 1-month price total return showing a significant decline of 26.56%.
InvestingPro Tips for PDS Biotech include an observation that analysts have revised their earnings upwards for the upcoming period, signaling potential optimism about the company's future performance. However, analysts also note that PDS Biotech is not expected to be profitable this year, which is a crucial consideration for investors. Additionally, PDS Biotech does not pay a dividend, which may influence investment decisions for those seeking income-generating stocks.
For investors seeking deeper insights into PDS Biotechnology Corporation, InvestingPro offers additional tips that can be accessed at https://www.investing.com/pro/PDSB. There are currently 9 additional InvestingPro Tips available for PDSB, which can help investors make more informed decisions. To enrich your investment analysis, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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