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P004 is a biosimilar monoclonal antibody candidate developed by Omexa Biologics, designed to match the reference biologic denosumab. Its primary mechanism of action is the inhibition of the Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). By binding to RANKL, P004 prevents it from activating its receptor, RANK, on the surface of osteoclasts and their precursors. This blockade inhibits osteoclast formation, function, and survival, which in turn decreases bone resorption and increases bone mineral density. P004 is being developed for the treatment of osteoporosis and the prevention of skeletal-related events in patients with bone metastases from solid tumors.
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