PDS Biotech Announces Positive Extended Follow-Up Data for VERSATILE-002 and Additional Trials Evaluating Versamune HPV to be Presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

- Median overall survival for CPS ≥1 is 30.0 months

Phase 3: Versamune HPV with pembrolizumab as 1L treatment of r/m HPV16-positive HNSCC

- Trial-in-progress currently enrolling patients

Conference call on Friday, May 23 at 8:00 a.m. ET to discuss ASCO abstract data sets

PRINCETON, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced publication of three Versamune HPV abstracts now available on the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting website. These abstracts summarize Versamune HPV (PDS0101) studies to be presented during the Head and Neck Cancer Poster Session taking place May 30-June 3, 2025, in Chicago, Illinois.

Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech stated, “We continue to be excited about the strength and durability of the VERSATILE-002 data showing the longest survival reported to date in 1L recurrent/metastatic (r/m) head and neck cancer (HNSCC). These results further strengthen our confidence in the ongoing VERSATILE-003 trial, which is the only registrational trial for the rapidly growing population of patients with HPV16-positive r/m HNSCC. Based on our estimates¹, HPV16-positive patients are as likely to progress to recurrent and/or metastatic stage as HPV-negative patients, and HPV16-positive patients currently comprise 40-60% of patients in the ICI-naïve r/m HNSCC population in the US.”

VERSATILE-002: Overall Survival of HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients Treated with T Cell Stimulating Immunotherapy PDS0101 and Pembrolizumab (Abstract #6037) - Poster Presentation. June 2, 2025, 9:00 a.m.-12:00 p.m. CDT

• Enrollment in the trial (n=53) is complete; 23 patients (including 3 still on treatment) continue to be followed for survival. No new safety signals have emerged
• Survival Results:
  • 39.3 months mOS in patients with CPS ≥ 20 (95% Confidence interval, lower limit of 18.4 months, upper limit net yet estimable (NE)); published mOS for pembrolizumab is approximately 15 months
  • 30.0 months mOS (95% CI 23.9, NE) in patients with CPS ≥ 1; published result for pembrolizumab is approximately 12 months
  • 29.5 months mOS (95% CI 15.3, NE) in patients with CPS 1-19; published result for pembrolizumab is approximately 10 months
• Median follow up of 18.4 months (range 0.2-42.7 months) represents one of the most extended follow-up periods to date of subjects receiving a therapy for HPV16-positive r/m HNSCC.
• Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at University of North Carolina, and Principal Investigator of the VERSATILE-002 Phase 2 clinical trial, will present the poster.

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Michl83 28.04.25, 16:12