On October 30, 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 corporate highlights and unaudited financial results for the third quarter of 2025.
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"We are excited to present initial clinical imaging data this November on MP0712, the 1st Radio-DARPin targeting DLL3, from compassionate care use in South Africa. The IND application for MP0712 has been filed and we see the alpha-targeting approaches for DLL3 in lung cancer as a valuable new modality for patients. Building on that progress, we are establishing a pipeline of additional Radio-DARPins with our partner Orano Med for selected targets, including mesothelin for ovarian cancer," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "MP0533 is the first-ever tetraspecific T-cell engager to demonstrate safety and efficacy in AML. We will report additional data on optimized dosing and a deeper understanding on the ideal patient profile for MP0533. This understanding is important to plan next steps and is supportive of positioning of our drug in the treatment landscape."
Research & Development Highlights
MP0712 (212Pb x DLL3), Radio-DARPin Pipeline and Collaboration 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 small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers, has been filed. Dialogue with the FDA is ongoing and, pending regulatory clearance, the Phase 1 trial is expected to initiate before the end of 2025.
Molecular Partners presented preclinical data in April at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, showing high tumor uptake, promising efficacy and a favorable safety profile for MP0712 in mouse models matching clinically-relevant DLL3 expression levels.
In H1 2025, Molecular Partners accepted a request from the Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa to provide MP0712 for imaging use under the legal framework in South Africa for compassionate care (also referred to as Section 21 of the Medicines and Related Substances Act). This approach enables the generation of initial images applying MP0712 labeled with 203Pb in patients with SCLC and other DLL3-expressing neuroendocrine cancers. As per courtesy of NuMeRI, the Company will present first images from the MP0712 compassionate care program at the Targeted Radiopharmaceuticals (TRP) Summit EU in November. The NuMeRI team, lead by Dr. Mike Sathekge, plans to report the full imaging and dosimetry data of MP0712 at the Theranostics World Conference (TWC) in January 2026.
203Pb and 212Pb are an element-equivalent pair of lead (Pb) isotopes, with 203Pb primarily used for imaging and 212Pb for therapeutic applications (targeted alpha therapy, TAT). As a "matched pair", pre-treatment imaging with 203Pb provides a prediction of treatment behavior with 212Pb.
In January 2025, Molecular Partners and Orano Med expanded their agreement to co-develop up to ten radiotherapy programs. In addition to its world class expertise and capabilities in the development of TAT with 212Pb, Orano Med will ensure the production of the 212Pb-based Radio-DARPins for clinical trials and commercialization. Orano Med possesses virtually unlimited source material for 212Pb production and has established robust and independent supply and manufacturing capabilities required for the seamless delivery of TAT to clinical sites internationally.
The second RDT program slated for clinical development is MP0726, targeting mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN, which has hampered the development of other MSLN-targeted therapeutics. The Company presented preclinical data on MP0726 at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in June. The Company is planning to progress several programs in 2026, including MP0726.
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 (NCT05673057). Molecular Partners presented updated data from the study at the 30th Annual European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June, with promising antitumor activity observed in cohort 8. Three of 8 (>30%) evaluable patients in this cohort achieved a clinical response after the first cycle, and two patients maintained their responses for over three months, including one patient still on treatment today (>12 months response duration). Cohort 8 benefited from a higher starting dose and a faster step-up dosing schedule, leading to improved exposure within the predicted therapeutic range and notable blast reduction in most patients, with an acceptable safety profile after dose adjustment.
Encouraged by these results, Molecular Partners amended the dosing scheme for cohorts 9 and 10 by further accelerating the step-up dosing, increasing the dosing frequency and introducing anti-CD20 premedication to achieve higher cumulative exposure as well as enhanced depth and duration of responses. Cohort 9 is exploring a lower target dose than cohort 8 to assess the safety of up to daily dosing in the first 14 days of treatment. Data from cohort 9 will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025. Cohort 10, which aims at reaching the same target dose as cohort 8 while exposing patients to more drug over time, is now enrolling and dosing patients.
MP0533 continues to show broad activity in a mutation-agnostic manner, with initial blast reductions in a majority of patients treated, and an acceptable safety profile. 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. Molecular Partners plans to explore MP0533 in combination settings, both in patients with relapsed/refractory disease as well as in front-line setting, should favorable antitumor activity continue to be observed. Several consortia have approached Molecular Partners expressing interest in conducting such studies. The Company is engaging with key opinion leaders and regulators to discuss next steps.
MP0317 (Tumor-Localized Agonist; FAP x CD40)
Molecular Partners is supporting an investigator-initiated trial of MP0317, for which a study protocol has been approved (NCT07036380). This proof-of-concept randomized Phase 2 study, to be conducted by an expert network in France, is designed for the treatment of patients with advanced cholangiocarcinoma in combination with anti-PD-L1 therapy (durvalumab) and gemcitabine-cisplatin-based chemotherapy. The main objective of the study is to assess the 12-month progression free survival (PFS) in the experimental arm (N = 50 patients).
MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies. Molecular Partners presented comprehensive biomarker analyses from the completed Phase 1 dose escalation trial of the localized CD40 agonist MP0317 in solid tumors at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2024.
Switch-DARPins (Next-Generation Immune Cell Engagers)
By employing a multi-specific Switch-DARPin, Molecular Partners aims to increase the safety and potency of T cell engagers (TCEs). Preclinical proof-of-concept for a novel CD3 Switch-DARPin TCE with CD2 costimulation was presented at AACR (Free AACR Whitepaper) in April 2025. The data show the feasibility of conditional T cell activation with potent co-stimulation in solid tumors, but not in healthy tissues. In addition, data showed that the CD3 Switch-DARPin activates T cells specifically in the presence of cells co-expressing the tumor targets MSLN and EpCAM, thereby increasing tumor specificity. The Company will present an update on the CD3 Switch-DARPin program at SITC (Free SITC Whitepaper) in November 2025.
Corporate Governance Highlights
Molecular Partners appointed Martin Steegmaier, Ph.D., as Chief Scientific Officer (CSO) and member of its Executive Committee, effective October 1, 2025. Martin brings a wealth of experience in oncology drug development, having previously contributed to the advancement of several innovative cancer therapies at major biotech and pharmaceutical companies.
(Press release, Molecular Partners, OCT 30, 2025, View Source [SID1234657157])