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PDS0301 (formerly M9241, NHS-IL12, or PDS01ADC) is an investigational tumor-targeted immunocytokine developed by PDS Biotech. It consists of a human IgG1 monoclonal antibody (NHS76) fused to two interleukin-12 (IL-12) heterodimers. The NHS76 antibody component specifically targets histone-DNA complexes exposed in regions of cellular necrosis, which is a common feature of solid tumors, thereby delivering IL-12 preferentially to the tumor microenvironment. This localized delivery is designed to enhance the proliferation, potency, and longevity of T cells and natural killer (NK) cells while minimizing the systemic toxicities historically associated with recombinant IL-12 therapy. PDS0301 is being evaluated as a monotherapy and in combination with other cancer therapies, including chemotherapy (such as docetaxel), hepatic arterial infusion pump (HAIP) floxuridine, and other immunotherapies, for the treatment of various solid tumors, including metastatic colorectal cancer, prostate cancer, Kaposi sarcoma, and HPV16-positive cancers.
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