MOLN - Molecular Partners to Present Initial Data from Ongoing Phase 1/2a Trial of MP0533 for Patients with Relapsed/Refractory AML and AML/MDS at the 65th ASH Annual Meeting and Exposition | Benzinga
- MP0533 shows acceptable safety profile in first three dose cohorts (5 patients total, data cut-off July 20); reported adverse reactions are of Grade 1/2 and no dose-limiting toxicity observed to date
- Emerging evidence of antitumor activity observed in dose cohort three, with one responder noted
- Data from ASH abstract released today support clinical proof of concept of MP0533 as a novel tetra-specific T cell engager
- Expanded data from the first three cohorts and data from fourth cohort will be presented at the ASH Annual Meeting and Exposition
ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR 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, will present preliminary data from its ongoing Phase 1/2a trial of MP0533, a novel tetra-specific T cell engager at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held from December 9–12 in San Diego, California. MP0533 is in development for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndrome (AML/MDS).
As of data cut-off (20 July 2023) of the abstract published today, five patients across three dosing regimens had been treated. The preliminary data reported indicate an acceptable safety profile, with no dose-limiting toxicity or Grade ?3 adverse reactions. Grade 1/2 events considered related to MP0533 included infusion-related reactions and cytokine release syndromes. One of the two patients evaluable for MP0533 antitumor activity in the third treatment cohort achieved a response. The study is currently enrolling its fifth cohort with up to seven dose-escalating cohorts planned and a total enrollment of up to 45 patients. The Company anticipates to present data including from the fourth dose cohort at the ASH Annual Meeting and Exposition in December this year.
"The data from the ASH abstract represent the beginning of an exciting and encouraging clinical journey for the MP0533 program. We are now able to show initial clinical activity of the first tetra-specific, non-antibody-based T cell engager, MP0533, in patients with r/r AML and MDS/AML," said Patrick Amstutz, Ph.D., Molecular Partners' CEO. "We see both an acceptable tolerability profile at initial doses, as well as the emergence of single-agent anti-tumor activity at relatively low dose levels and we look forward to presenting additional data on MP0533's potential to treat this particularly intractable blood ...