PRINCETON, N.J. — November 10, 2025 — Leads & Copy — PDS Biotechnology Corporation (Nasdaq: PDSB) announced positive clinical and translational data that were presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, showcasing immune-driven mechanisms and biomarkers that underscore the clinical activity of its HPV16-targeted immunotherapy PDS0101 and immunocytokine PDS01ADC.
The studies, part of a collaborative research agreement with the National Cancer Institute (NCI) Center for Cancer Research (CCR), included presentations such as a rapid oral abstract and two poster presentations at SITC 2025.
Frank Bedu-Addo, Ph.D., President and CEO of PDS Biotech, stated that the data validate the scientific basis of their immunotherapy platforms and confirm the effectiveness of their development approach. He added that the findings enhance understanding of how the immunotherapies generate promising results in advanced cancers, boosting confidence in the programs and supporting the regulatory strategy for commercialization.
Key highlights from the PDS0101 data, derived from a rapid oral abstract presentation, included an analysis of 50 patients with HPV16-positive cancers treated with a combination of PDS0101, PDS01ADC, and an immune checkpoint inhibitor. The analysis demonstrated broad immune activation and increased pro-inflammatory cytokines, which are essential for T cell recruitment and potency.
The findings also revealed that measurements of immunological proteins in the blood could accurately predict clinical benefit, supporting the continued evaluation of these biomarkers and validation of predictive models in future clinical trials. These translational results further reinforce the clinical activity observed across three Phase 2 trials, providing a strong rationale for biomarker-guided optimization of immunotherapy combinations based on PDS0101.
Data highlights from PDS01ADC, an IL-12 tumor-targeting immunocytokine, showed that monotherapy promoted multi-functional NK cell generation, which correlated with clinical responses in patients with solid tumors. Furthermore, specific types of NK cells linked to effective killing increased, while those associated with poor anti-tumor response decreased, both contributing to improved clinical outcomes.
Additional findings indicated that PDS01ADC monotherapy increased stem-like memory T cells with self-replicating properties, and this increase was associated with disease stabilization in 28 patients with advanced solid tumors. These data show that PDS01ADC promotes specific self-replicating T cells that enhance the durability of anti-tumor immunity.
According to Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, the immune signatures observed with PDS0101 and PDS01ADC deepen the understanding of how these therapies create an anti-tumor immune response. The presented translational data validate the company’s platforms and will help design future studies and combination approaches.
PDS Biotech is progressing the development of PDS0101 with Keytruda® in a Phase 3 trial for recurrent/metastatic head and neck cancer. Additionally, PDS01ADC is being advanced through NCI-led Phase 2 trials in metastatic colorectal cancer, cholangiocarcinoma, biochemically recurrent prostate cancer, and castration-resistant and castration-sensitive prostate cancer.
PDS Biotechnology is focused on developing immunotherapies that target and kill cancers, with a focus on HPV-related cancers and other solid tumors.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email: david.schull@russopartnersllc.com
Source: PDS Biotechnology Corporation
