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**INI-4001 + cemiplimab** is an investigational combination therapy for advanced solid tumors. INI-4001 is a novel small molecule agonist of Toll-like receptor 7 and 8 (TLR7/8) optimized for nanoparticle delivery, developed by Inimmune. It is designed to activate innate immune responses, increasing antigen presenting cell (APC) activity, IFNα production, and stimulating CD8 T cell antitumor activity. Cemiplimab is an approved monoclonal antibody checkpoint inhibitor targeting PD-1, enhancing adaptive immune responses against tumors. The combination aims to leverage both innate and adaptive immune system activation in patients with advanced solid tumors who progress or have stable disease after initial INI-4001 monotherapy.
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