H.C. Wainwright has reaffirmed its Buy rating and $21.00 price target for PDS Biotechnology Corp (NASDAQ: NASDAQ:PDSB), following an update from the company's IMMUNOCERV trial.
The Phase 2 study, in partnership with MD Anderson, evaluates the safety and antitumor efficacy of PDS0101 combined with standard of care chemo-radiation in patients with locally advanced cervical cancer.
The IMMUNOCERV trial enrolled 17 patients with large tumors, who received at least two doses of Versamune HPV, with a median follow-up time of 19 months.
The study's findings revealed an 84.4% overall survival rate at 36 months, which increases to 100% for patients who received all five doses of the treatment. This compares favorably to a historical 36-month overall survival rate of approximately 64% with chemoradiation alone.
Additionally, a 36-month progression-free survival rate stood at 74.9% among all patients, reaching 100% in those who completed the full Versamune HPV regimen, surpassing the historical rate of around 61%.
The trial also reported a complete metabolic response in 88% of the participants. Versamune HPV was noted to be safe and well-tolerated, with the most common treatment-related side effects being injection site reactions, affecting 71% of the patients. This safety profile is significant as there are currently no FDA-approved HPV-targeted immunotherapies for cervical cancer.
The positive outcomes from the IMMUNOCERV trial indicate that the combination of PDS0101 and chemoradiation not only demonstrates safety with minimal toxicity but also significantly outperforms historical data in terms of overall survival and progression-free survival rates.
In other recent news, PDS Biotechnology Corporation reported positive outcomes from its Phase 2 IMMUNOCERV clinical trial assessing the efficacy of Versamune® HPV in treating locally advanced cervical cancer.
The trial demonstrated an 84.4% overall survival rate at 36 months, which increased to 100% for patients who received all five doses of the treatment. The company also released updated clinical trial data for its Versamune® HPV therapy in combination with KEYTRUDA®, showing a median overall survival of 30 months.
PDS Biotech has entered into an Amended and Restated At Market Issuance Sales Agreement with B. Riley Securities, Inc. and H.C. Wainwright & Co., LLC, allowing the sale of up to $50 million of its common stock. In an earnings call, the company 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.
InvestingPro Insights
PDS Biotechnology Corp's (NASDAQ:PDSB) recent positive trial results are reflected in its market performance. According to InvestingPro data, the company has seen a significant 31.31% return over the last week and a 36.09% return over the last month, indicating strong investor confidence in the wake of the IMMUNOCERV trial update.
Despite these promising clinical outcomes, it's important to note that PDSB is not yet profitable. An InvestingPro Tip reveals that analysts do not anticipate the company will be profitable this year. This is typical for biotech companies in the development stage, as they often incur substantial research and development costs before generating revenue from approved products.
Another relevant InvestingPro Tip highlights that PDSB holds more cash than debt on its balance sheet. This financial position could be crucial for funding further clinical trials and potential commercialization efforts for PDS0101.
For investors seeking a more comprehensive analysis, InvestingPro offers 10 additional tips for PDSB, providing a deeper understanding of the company's financial health and market position.
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