On November 3, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported it will present updated data from a Phase 1/2a trial of MP0533, a novel, multispecific T cell engager for acute myeloid leukemia (AML) patients, in a poster at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida, and online.
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The poster will outline latest results of this first-in-human, multicenter, open-label study evaluating MP0533 in relapsed/refractory AML and myelodysplastic syndrome (MDS)/AML patients (ClinicalTrials.gov: NCT05673057). MP0533 shows an acceptable safety profile across DR 1–9. Based on initial data, densified MP0533 dosing as used in DR 8 and 9 appears tolerable, and preliminary antitumor activity signs are encouraging. The study is currently dosing patients in DR 10.
MP0533 is a novel tetra-specific T cell-engaging DARPin, which simultaneously targets three tumor-associated antigens CD33, CD123 and CD70 on AML cells as well as the immune activator CD3 on T cells. AML cells commonly co-express at least two of the three target antigens, whereas most healthy cells only express one or none. MP0533 binds with increasing avidity as the number of its target antigens present increases, thereby preferentially binding to AML cells over healthy cells. This unique mode of action is designed to enable T cell-mediated killing of AML cells while preserving a therapeutic window that minimizes damage to healthy cells.
Details of the presentation
Title: Phase 1/2 study of MP0533, a tetra-specific T cell engager (CD33 x CD123 x CD70 x CD3), in patients with relapsed/refractory AML or MDS/AML: Initial results from optimized treatment regimen including densified MP0533 dosing and adapted premedication
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II
Session Date: December 7, 2025
Presentation Time & Location: 6:00– 8:00 PM ET; OCCC, West Halls B3–B4
Publication Number: 3419
The full abstracts will be available on the ASH (Free ASH Whitepaper) website from 9:00 am ET on Monday November 3, 2025.
(Press release, Molecular Partners, NOV 3, 2025, View Source [SID1234659288])