NEU-002

NEU-002 is a first-in-class, systemically delivered biologic drug candidate developed by Onchilles Pharma for the treatment of solid tumors. It leverages the ELANE pathway, a novel innate immune mechanism discovered by Dr. Lev Becker, in which neutrophil elastase (ELANE) selectively kills cancer cells while sparing healthy tissue. NEU-002 is specifically engineered for intravenous administration and overcomes inhibition from serine protease inhibitors in blood, maintaining full enzymatic activity and enhanced substrate specificity. Its primary mechanism involves cleaving CD95 on cancer cells to induce immunogenic cell death (ICD), leading to both immediate tumor cell killing and mobilization of an adaptive anti-tumor immune response with potential for durable immunity. Preclinical studies have demonstrated selective killing of primary human cancer cells (including ovarian and breast cancers), sparing adjacent healthy tissues and critical immune cells, as well as complete responses with resistance to tumor rechallenge in mouse models[3][4][7][10].