PDS Biotechnology Corp. (PDSB:NASDAQ) has announced positive updated data from its IMMUNOCERV trial, showcasing enhanced survival rates in patients with advanced cervical cancer treated with PDS0101 in combination with standard chemoradiation. The results, presented at the ASTRO '24 conference, have led H.C. Wainwright to maintain a Buy rating on PDS Biotechnology with a price target of US$21.00.
The IMMUNOCERV trial, a Phase 2 study conducted in partnership with MD Anderson, evaluated the safety and efficacy of PDS0101 combined with chemoradiation in patients with locally advanced cervical cancer. The 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.
Key Findings from the IMMUNOCERV Trial
The study's findings revealed an 84.4% overall survival (OS) rate at 36 months. Notably, the overall survival rate increased to 100% for the eight patients who received all five doses of Versamune HPV. This compares favorably to historical data, which shows approximately a 64% overall survival rate at 36 months with chemoradiation alone in this patient population.
Progression-free survival (PFS) rates were also promising, with a 74.9% PFS rate at 36 months among all patients. Similar to the OS results, the PFS rate reached 100% for those patients who received all five doses of Versamune HPV. Historical data indicates a 36-month PFS rate of approximately 61% with chemoradiation alone.
Furthermore, the trial reported a complete metabolic response in 88% of the participants. Versamune HPV was well-tolerated, with the most common treatment-related side effects being injection site reactions, affecting 71% of the patients.
Analyst Perspective
H.C. Wainwright analyst Dr. Joseph Pantginis highlighted the significance of these results, stating that the combination of PDS0101 and chemoradiation appears safe with minimal toxicity, and the OS and PFS outcomes significantly beat historical controls. He also noted the absence of FDA-approved HPV-targeted immunotherapies for this tumor type, emphasizing the potential of PDS0101 in cervical cancer treatment.
Strategic Implications for PDS Biotechnology
The positive outcomes from the IMMUNOCERV trial suggest that PDS0101 could address a significant unmet need in the treatment of HPV-related cancers. The company is also exploring the potential of Versamune HPV therapy in combination with KEYTRUDA, with updated clinical trial data showing a median overall survival of 30 months.
PDS Biotechnology has entered into an agreement allowing the sale of up to $50 million of its common stock, and the company is planning 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, signaling a positive outlook for future developments.
