PDS Biotech Seeks FDA Approval After New NCI Data

PDS Biotechnology said the National Cancer Institute will present three abstracts at the 2025 SITC Annual Meeting reporting clinical and translational findings from its platforms, including a tumor‑targeting IL‑12 antibody‑drug conjugate (PDS01ADC) and its lead Phase 3 HPV‑targeted immunotherapy PDS0101. One abstract reports that a tumor‑targeting IL‑12 immunocytokine increased peripheral natural killer (NK) cells with phenotypes associated with enhanced tumor‑cell lysis in patients with advanced solid tumors. CEO Frank Bedu‑Addo highlighted the company’s NCI collaboration and said the programs aim to engage both adaptive and innate immunity to improve outcomes for difficult‑to‑treat cancers. PDS Biotech has also requested a meeting with the FDA to explore an expedited approval pathway for PDS0101 in HPV16‑positive disease. These disclosures arrive amid a broadly active immuno‑oncology landscape, underscoring continued investment in checkpoint inhibitors and complementary immune approaches.