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PDS Biotechnology Announces Translational Data Showing Strong Immunological and Clinical Activity of PDS0101 and PDS01ADC Presented at SITC 2025

Core Insights - PDS Biotechnology Corporation announced positive clinical and translational data for its investigational immunotherapies PDS0101 and PDS01ADC at the 2025 Society for Immunotherapy of Cancer Annual Meeting, highlighting their potential in treating advanced cancers [1][3][13] Group 1: Clinical Data and Presentations - The studies were conducted under a collaborative research and development agreement with the National Cancer Institute, featuring one rapid oral abstract and two poster presentations at SITC 2025 [2] - PDS0101 demonstrated strong clinical activity across three phase 2 trials, establishing a link between immune signatures and clinical response, supporting future biomarker-guided optimization [6][4] Group 2: Mechanisms of Action - PDS01ADC reprograms natural killer (NK) cells to enhance their cancer-killing capabilities and promotes the generation of stem cell-like killer T cells and memory T cells, contributing to long-lasting anti-tumor activity [8][11] - Analysis of 50 patients with advanced HPV16-positive cancers showed significant immune activation and increases in pro-inflammatory cytokines, which are crucial for T cell recruitment and potency [9] Group 3: Future Development and Trials - PDS Biotech is advancing PDS0101 in a phase 3 clinical trial in combination with Keytruda for HPV16-positive recurrent/metastatic head and neck cancer, while PDS01ADC is being evaluated in multiple phase 2 trials for various cancer types [13][17] - The findings from SITC 2025 strengthen the scientific foundation of the company's immunotherapy platforms and support ongoing regulatory and clinical milestones [13][17]