Molecular Partners presents positive data from ongoing Phase 1/2a trial of MP0533 in AML at EHA 2025

Core Viewpoint - Molecular Partners AG announced positive updated data from a Phase 1/2a trial of its tetraspecific T-cell engager MP0533 for relapsed/refractory acute myeloid leukemia (AML) at the EHA Congress in Milan [1][2] Group 1: Trial Results - In cohort 8, 3 out of 8 evaluable patients (over 30%) achieved a clinical response after the first cycle, including 1 complete response and 2 complete responses with partial hematologic recovery [3] - Patients in cohort 8 maintained exposure to MP0533 for over 4 days within the predicted therapeutic range, with 5 out of 8 patients showing more than 50% blast reduction [4] - The safety profile of MP0533 was deemed acceptable after the adjustment of the target dose in cohort 8 [9] Group 2: Dosing Regimen - Cohort 8 implemented a higher starting dose and an additional day of dosing, reaching the target dose by day 12 instead of day 15, which contributed to improved clinical responses [3][6] - The amended protocol for cohort 9 includes further acceleration of the step-up dosing, increased frequency of dosing, and the introduction of anti-CD20 premedication to enhance therapeutic exposure and response duration [7][9] - Initial data from cohort 9, which is currently dosing patients, is expected in the second half of 2025 [8] Group 3: Company Overview - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, with oncology as its main area of focus [10] - The company was founded in 2004 and operates in both Zurich, Switzerland, and Concord, Massachusetts, USA [10]