PDS Biotechnology announces publication of PDS0301 study

PDS Biotechnology announced that clinical research conducted by the NCI, one of the Institutes of the National Institutes of Health, was published in the peer-reviewed journal, International Immunopharmacology. The clinical study assessed immune changes in relation to the dose level and dosing schedule of PDS0301, NHS-IL12, a novel investigational fusion protein consisting of a tumor-targeting antibody conjugated to Interleukin 12. The study also evaluated the correlation of several treatment-related immunological changes with clinical responses. As described in the paper, titled, "Immune correlates with response in patients with metastatic solid tumors treated with a tumor-targeting immunocytokine NHS-IL12," the researchers at the NCI evaluated a subset of 23 patients with advanced cancers who participated in a Phase 1 clinical trial of PDS0301. Patients were dosed every 2 weeks with PDS0301 at one of two levels – 12.0 mcg/kg and 16.8 mcg/kg – or every 4 weeks at 16.8 mcg/kg to identify dosing amounts and regimens of PDS0301 that correlate with higher levels of immune activation, including quantities of CD8 T cells, immune suppressive T regulatory cells, natural killer cells and natural killer T cells. The ability to limit exposure of IL-12 in the circulating blood, and to increase its presence within the tumors constitutes a significant advancement in the development of cytokine-based immunotherapy. "The research published by the NCI demonstrates the potential of PDS0301 as a tumor-targeting IL-12 and its ability to stimulate immune activation and increase the frequency of CD8 T cells and certain NK cell subsets to potentially overcome the immunosuppressive tumor microenvironment," stated Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "Importantly, this study appears to demonstrate the safety and tolerability of biologically active doses of PDS0301 and reports increases in specific immune cells that were associated with PDS0301 administration and improved clinical outcomes."