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ELVN-002 is a potent, highly selective, irreversible small molecule inhibitor of the human epidermal growth factor receptor 2 (HER2), designed to target both wild-type and mutant forms of HER2—including Exon 20 insertion mutations—while sparing wild-type EGFR. It is central nervous system (CNS) penetrant and aims to avoid EGFR-related toxicities seen with other tyrosine kinase inhibitors. ELVN-002 inhibits HER2-mediated signaling pathways, leading to cell death in HER2-expressing tumor cells. Preclinical data show robust anti-tumor activity in models of HER2-driven cancers and enhanced efficacy when combined with antibody-drug conjugates or trastuzumab. The drug is being developed primarily for the treatment of advanced solid tumors harboring HER2 alterations, including non-small cell lung cancer (NSCLC), breast cancer, colorectal cancer, and other HER2-positive solid tumors[1][3][4][6].
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