PRINCETON, N.J. - PDS Biotechnology (NASDAQ:PDSB) Corporation (NASDAQ:PDSB), a late-stage immunotherapy company, announced positive outcomes from its Phase 2 IMMUNOCERV clinical trial, assessing the efficacy of Versamune® HPV in combination with chemoradiation for treating locally advanced cervical cancer. The results were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024.
The trial, which enrolled 17 high-risk patients with large tumors, showed an 84.4% overall survival rate at 36 months, rising to 100% among the eight patients who received all five doses of Versamune® HPV. The 36-month progression-free survival rate was 74.9% for all participants, reaching 100% for those who completed the full treatment regimen. These rates compare favorably to historical data where the 36-month overall survival rate is approximately 64%, and progression-free survival is around 61% with chemoradiation alone.
Additionally, a complete metabolic response was observed in 88% of the patients. The treatment was generally well-tolerated, with the most common side effects being injection site reactions, affecting 71% of the patients.
Dr. Ann Klopp of The University of Texas MD Anderson Cancer Center highlighted the lack of FDA-approved HPV-targeted immunotherapies for cervical cancer and suggested that the data warrant further investigation into Versamune® HPV's safety and efficacy.
Frank Bedu-Addo, CEO of PDS Biotech, expressed satisfaction with the clinical activity and safety profile demonstrated in the trial. He noted that the company is looking forward to advancing Versamune® HPV's development for treating locally advanced cervical cancer.
PDS Biotechnology plans to initiate a pivotal clinical trial in 2024 for its lead program in advanced HPV16-positive head and neck squamous cell cancers. Versamune® HPV is also being developed in combination with other therapeutic agents, including immune checkpoint inhibitors and an IL-12 fused antibody drug conjugate (ADC).
The results from the IMMUNOCERV trial are based on a press release statement from PDS Biotechnology Corporation.
In other recent news, PDS Biotechnology Corporation has been making significant strides in the medical field. The company recently reported updated clinical trial data for its Versamune® HPV therapy, showing a median overall survival of 30 months, a notable improvement from previous results. The Versamune® HPV therapy, combined with KEYTRUDA®, is being tested for treating HPV16-positive head and neck squamous cell carcinoma (HNSCC). The company plans to initiate a Phase 3 clinical trial, VERSATILE-003, later this year to further evaluate the efficacy of this combination therapy.
In addition to its clinical advancements, PDS Biotech has also entered into an Amended and Restated At Market Issuance Sales Agreement with B. Riley Securities, Inc. and H.C. Wainwright & Co., LLC. This agreement allows the company to sell up to $50 million of its common stock in at-the-market offerings. The company has the right to instruct the agents regarding the sale of the shares, including price, timing, and size of the transactions.
During a recent earnings call, PDS Biotech outlined plans for upcoming Versamune HPV trials, aiming to enroll 400-450 patients. The FDA has shown support for the company's trial designs, which include both double and triple drug combinations. The company has emphasized the favorable safety profile observed in earlier trials and the potential for accelerated approval through fast-track designation. The company is advancing its lead program into a registrational trial in 2024. These are the latest developments for PDS Biotechnology Corporation.
InvestingPro Insights
PDS Biotechnology Corporation's (NASDAQ:PDSB) recent positive clinical trial results align with some encouraging financial metrics and analyst sentiments. According to InvestingPro data, the company has seen a significant return over the last week, with a 20.46% price total return. This short-term boost likely reflects the market's positive reaction to the IMMUNOCERV trial outcomes.
Despite the promising clinical results, it's important to note that PDSB is currently not profitable, with a negative operating income of -$39.71 million over the last twelve months as of Q2 2023. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year. However, the company's strong cash position is a positive factor, with another InvestingPro Tip highlighting that PDSB holds more cash than debt on its balance sheet.
The company's market capitalization stands at $134.39 million, reflecting its status as a smaller, development-stage biotech firm. While PDSB's stock has shown volatility, as noted in an InvestingPro Tip, it has demonstrated strong returns over the last month (14.06%) and three months (23.73%), potentially indicating growing investor confidence in the company's pipeline.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for PDSB, providing a deeper understanding of the company's financial health and market position.
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