PDS Biotech Reports Durable 30-Month Median Overall Survival In 1L Recurrent/Metastatic HNSCC, Highlights Urgent Need In Rapidly Rising HPV16-Positive Cases

Median overall survival data in first-line recurrent/metastatic (1L r/m) HNSCC remains durable at 30.0 months with additional follow-up of ~4.5 months beyond the initial abstract

HPV16-positive is the most rapidly increasing HNSCC in the US

VERSATILE-003 is the only ongoing Phase 3 clinical trial exclusively addressing 1L r/m HPV16-positive HNSCC

PRINCETON, N.J., June 02, 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 that were presented during the Head and Neck Cancer Poster Session taking place May 30-June 3, 2025, in Chicago, Illinois.

It is estimated that over 50% of head and neck squamous cell carcinoma (HNSCC) cases in the US are HPV16-positive.1 HPV-positive and HPV-negative HNSCC are two distinct diseases with different underlying causes, origin, risk factors, and contributions to the development of HNSCC. Multiple types of HPV are associated with HSNCC, and those cases are commonly identified with a p16 histochemistry test and referred to as p16-positive. A p16-positive test result suggests that the patient's cancer may be due to any of the over 100 types of HPV. PDS Biotech is specifically addressing HNSCC related to HPV type 16 (HPV16), the most carcinogenic type of HPV. 2 HPV16-positive HNSCC has been identified as a rapidly growing and severe medical need.3,4 HPV16 is a specific type of HPV that must be confirmed using a polymerase chain reaction (PCR) test.