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Wednesday, June 18, 2025

Aptevo Mipletamig Demonstrates Compelling Clinical Activity in Frontline AML

Aptevo Therapeutics (NASDAQ:APVO) reported promising clinical data from its Phase 1b/2 RAINIER trial evaluating mipletamig, a CD123 x CD3 bispecific antibody, combined with venetoclax and azacitidine for frontline AML patients unfit for intensive chemotherapy. The triplet therapy achieved an impressive 85% remission rate across two trials, significantly outperforming competitor studies. Notable safety outcomes include no cytokine release syndrome (CRS) in cohorts 1 and 2. Three patients with poor prognosis achieved complete remission, with one successfully proceeding to transplant. The trial's Cohort 3 is nearing full enrollment at the highest dose level. Mipletamig's unique CRIS-7 binding domain engineering strategy demonstrates potential in mitigating cytokine-related toxicity while maintaining anti-cancer activity.

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