PDSB News & Events

PDS Biotechnology announced the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes PFS as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the trial's primary endpoint for full approval, consistent with the Company's prior regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration. Following the FDA's standard 30-day wait period since filing of the amended protocol to the Investigational New Drug Application, without objection, the Company is proceeding with the amended protocol.

PDS Biotechnology announced that results of a National Cancer Institute-led study of the Company's investigational Interleukin-12 tumor targeted immunocytokine, PDS01ADC, were presented at the American Association of Cancer Research, AACR, special conference on prostate cancer research, held in Boston, MA on January 20-22, 2026. The study, titled Docetaxel and the Tumor-Targeting Interleukin-12 PDS01ADC in Patients with Metastatic Castration-Resistant Prostate Cancer, was presented by Melissa Abel, MD., Assistant Research Physician, Genitourinary Malignancies Branch, Center for Cancer Research, at the NCI, part of the National Institutes of Health. The clinical study is being done to evaluate the ability of PDS01ADC to enhance responses to docetaxel in advanced prostate cancer, based on the potential synergy of PDS01ADC with the necrosis inducing chemotherapeutic agent. The study was performed in advanced cancer patients, the majority of whom had failed 2nd line treatment with androgen deprivation therapy and an androgen pathway inhibitor, and therefore had few remaining treatment options. Results showed median progression-free survival of 9.6 months for the combination therapy in mCRPC patients. Additionally, a promising median PSA decline of 40% was observed, with 6 of 16 patients achieving greater than 50% decline.

PDS Biotechnology announced that the U.S. Patent Office has issued a Notice of Allowance for the Company's lead asset, PDS0101. "This patent reinforces the value of our proprietary Versamune platform and our lead asset PDS0101 as we advance through late-stage development," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "With VERSATILE-003 progressing and a robust intellectual property portfolio now extending across multiple major markets, we are well-positioned to bring this promising immunotherapy to patients with head and neck cancers."

PDS Biotechnology announced that the Company has submitted a protocol amendment to the U.S. FDA for its Phase 3 VERSATILE-003 clinical trial. The proposed amendment to the VERSATILE-003 Phase 3 trial changes the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power, potentially providing the basis for accelerated approval of PDS0101. Median overall survival remains the primary endpoint for full approval as originally recommended by FDA. The submission follows a constructive Type C meeting held with the FDA in December 2025 to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The amendment is supported by positive final results from the Company's VERSATILE-002 trial, which showed promising mOS and durable PFS.