Clinical Read2026-06-30

MP0533

Molecular Partners AGMOLN
Indication
Acute myeloid leukemia (AML)
Stage
phase1
Event
Interim Data
Details

March 12, 2026: Molecular Partners AG (SIX/NASDAQ: MOLN) reported FY2025 results and provided R&D updates, highlighting progress in targeted alpha radiotherapy and immune oncology.

MP0712 (DLL3-targeting Radio-DARPin Therapy with 212Pb; with Orano Med): Initiated a US multi-center Phase 1/2a trial (NCT07278479) in small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers; recruitment is open. The study includes pre-treatment imaging/dosimetry using 203Pb-labeled MP0712 and aims to assess safety and determine a recommended Phase 2 dose. Initial clinical data are expected in 2026. The company presented first patient imaging/dosimetry data (5 evaluable patients) at the 8th Theranostics World Congress (Jan 2026), showing specific tumor uptake/accumulation with limited healthy-tissue uptake.

MP0726 (MSLN-targeting Radio-DARPin; with Orano Med): Advancing toward first-in-human imaging; preclinical data were presented at SNMMI 2025. Nomination of new Radio-DARPin candidates is anticipated mid-2026.

Radio-DARPin isotopes/partnership: Signed a non-exclusive development agreement with Eckert & Ziegler to enable use of multiple isotopes including 225Ac; plans to present preclinical multi-isotope data at the 3rd Global Radiopharmaceuticals Development Summit (March 2026, Shanghai).

MP0317 (tumor-localized CD40 agonist): Investigator-initiated randomized Phase 2 trial in advanced cholangiocarcinoma (France; NCT07036380) is open with two sites activated; patient dosing is ongoing (75 patients; MP0317 + durvalumab + gemcitabine/cisplatin vs SoC).

MP0533 (tetra-specific T cell engager): Phase 1/2a in r/r AML and MDS/AML (NCT05673057) continues; ASH 2025 data suggested densified dosing is tolerable with improved exposure and antitumor activity; update and clinical-path plan expected in H1 2026.

Switch-DARPin TCE (MSLN/EpCAM): Lead candidate nomination planned in H1 2026; program update planned at AACR 2026.