Molecular Partners reports financial results and highlights recent clinical pipeline progress for H1 2025
MP0533 data presented at European Hematology Association (EHA) highlights improved response rates and antitumor activity in low disease burden patients; additional data under amended dosing scheme expected in Q4 2025
IND filing on first radio-DARPin program MP0712 and initiation of Phase 1 trial expected by end 2025; update on early imaging work planned in Q4 2025; expanded strategic radiotherapy partnership with Orano Med
Appointed Martin Steegmaier, Ph.D. as CSO and member of Executive Committee
Cash and cash equivalents and short-term time deposits total of CHF 114 million as of June 30, 2025, extending runway into 2028.
ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Aug. 25, 2025 (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 ("Molecular Partners" or the "Company"), today announced corporate highlights and unaudited financial results for the first half of 2025.
"Molecular Partners continues to make good progress towards key development milestones, notably in our two clinical programs. Following the expansion of our strategic radiotherapy partnership with Orano Med in January, we are advancing our lead program MP0712 towards its first-in-human trial. With the data package complete, we anticipate the IND filing and Phase 1 initiation in 2025, and initial clinical data in H1 2026. Our multispecific T cell engager MP0533 is making progress in its Phase 1/2a trial for acute myeloid leukemia. Recently presented data show both increased response rates and greater depth of responses and we look forward to presenting the first data under the amended study protocol in Q4 2025. We also strengthened our leadership with the appointment of Martin Steegmaier, Ph.D., as CSO, further underlining our commitment to delivering improved treatment options for patients and significant value for our stakeholders. Our finances remain robust with funding projected into 2028," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.
Research & Development Highlights
MP0533 (Multispecific T Cell Engager; CD33 x CD123 x CD70 x CD3)
MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)/AML (ClinicalTrials.gov: NCT05673057). Molecular Partners presented updated data from the study at the 30th Annual European Hematology Association (EHA) Congress in June, outlining the impact of accelerated step-up dosing regimen of MP0533 on exposure and clinical responses in cohort 8, providing the rationale for further optimization to the dosing regimen implemented in the ongoing cohort 9.Initial data from cohort 8 show promising antitumor activity: 3 of 8 (>30%) evaluable patients with relapsed/refractory disease achieved a clinical response after the first cycle, with one complete response and two complete responses with partial hematologic recovery. Notably, two patients maintained their responses for over three months, including one patient still responding after more than six months at data cutoff (14 April 2025) and still on treatment today. This cohort benefited from a higher starting dose and a faster step-up dosing schedule, leading to prolonged exposure within the predicted therapeutic range and notable blast reduction in most patients, with an acceptable safety profile after dose adjustments in cohort 8.
Encouraged by these results, Molecular Partners amended the study protocol for cohorts 9 and 10 by further accelerating the step-up dosing, increasing the dosing frequency and introducing anti-CD20 premedication for greater cumulative exposure. These changes aim to enhance both the depth and duration of patient responses. Cohort 9 is exploring a lower target dose than cohort 8 to assess the safety of up to daily dosing for the first 14 days of treatment, leading to significantly denser dosing; cohort 10 aims at reaching the same target dose as cohort 8 while exposing patients to more drug over time. Initiation of cohort 10 is anticipated to start in the coming weeks, pending appropriate approvals. Cohort 9 is now fully recruited, with initial data expected to be presented in Q4 2025.
MP0533 continues to show broad activity, with initial blast reductions in a majority of patients treated. The data continue to indicate that the patients more likely to see durable responses will be those who initiate therapy with a lower level of blasts at baseline. Looking forward, Molecular Partners plans to explore future cohorts of MP0533 in combination settings, both in relapsed/refractory as well as in front-line patients, should favorable antitumor activity continue to be observed. The company is engaging with regulators such as the U.S. Food and Drug Administration (FDA) to discuss next steps.
MP0712 (212Pb x DLL3), Radio-DARPin Pipeline and Global Partnership with Orano Med
The Phase 1 Investigational New Drug (IND) application for MP0712, a 212Pb-based Radio-DARPin therapy (RDT) candidate targeting the tumor-associated protein delta-like ligand 3 (DLL3), co-developed with Orano Med for the treatment of ...
