PDS Biotechnology Delivers Strong Q4 2025 Results, Advancing Clinical Programs with Promising Treatments for HPV-16 Positive Head and Neck Cancer and Metastatic Castration-Resistant Prostate Cancer
PDS Biotechnology Corporation has reported a successful fourth quarter of 2025, marked by significant progress across its clinical programs. The company's management team, comprising Dr. Frank Bedu-Addo (Chief Executive Officer), Dr. Kirk Shepherd (Chief Medical Officer), and Lars Boesgaard (Chief Financial Officer), provided an update on the company's recent highlights during a conference call on March 30, 2026.
Dr. Bedu-Addo highlighted the company's achievement in advancing its clinical programs, with a focus on PDS0101 for HPV-16 positive head and neck cancer. The VERSATILE-003 trial protocol amendment aims to create a more efficient path to accelerated approval, shortening the trial duration, reducing costs, and accelerating the timeline to regulatory submission while preserving overall survival as the basis for full approval.
The company also announced early results from a National Cancer Institute-led trial investigating PDS-01ADC, an investigational IL-12 tumor-targeted immunocytokine. In patients with metastatic castration-resistant prostate cancer, the combination of PDS-01ADC and standard of care docetaxel demonstrated encouraging median progression-free survival (PFS) of 9.6 months and a median prostate-specific antigen (PSA) decline of 40%. Notably, six out of 16 patients achieved greater than 50% PSA decline.
Dr. Shepherd provided further insight into the VERSATILE-003 trial amendment, citing the strength of the final data from the VERSATILE-002 phase II trial and the sub-analysis announced in September as key factors driving the strategic decision to seek an amendment to include progression-free survival (PFS) as a primary endpoint.
PDS Biotechnology has also strengthened its intellectual property estate for PDS0101 with new patents granted in the United States and Japan. The new U.S. patent, combined with anticipated biologics exclusivity for PDS0101, extends market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets.
Dr. Shepherd noted that the data and rationale behind the decision to amend the study protocol were driven by the strength of the final data from the VERSATILE-002 trial and the sub-analysis announced in September, leading to a strategic decision to seek an amendment to include progression-free survival (PFS) as a primary endpoint.
The company's focus on advancing its clinical programs with promising treatments for HPV-16 positive head and neck cancer and metastatic castration-resistant prostate cancer positions it well for future growth. PDS Biotechnology's commitment to delivering innovative solutions for patients in need continues to drive the company forward.
