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Interleukin-12 protein (rHuIL-12) is a recombinant human cytokine biologic being developed by ICaPath for the treatment of pleomorphic neoplastic diseases, osteosarcomas, and Stage 4 metastatic cancers. As a pro-inflammatory heterodimeric protein composed of p35 and p40 subunits, it acts as an agonist of the interleukin-12 receptor pathway to induce systemic immunostimulation. Its mechanism of action involves the activation of T cells and natural killer (NK) cells, promoting a robust anti-tumor immune response, and it may also exert anti-angiogenic effects. The program is currently in the preclinical stage, and the protein serves as the active ingredient for ICaPath's lead therapeutic candidate, ICP-001, which encapsulates the cytokine in PLGA nanoparticles for controlled systemic delivery. An FDA pre-IND meeting for the program was completed in 2022.
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