MOLN News & Events

Molecular Partners announced the publication of Phase 1 clinical data in Nature Cancer demonstrating the potential of the tumor-localized CD40 agonist, MP0317, to modulate the tumor microenvironment. MP0317 is designed to activate immune cells specifically within the TME by anchoring to fibroblast activation protein, which is expressed in high amounts in the stroma of various solid tumors. This tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies. The peer-reviewed paper published by Steehgs et al., entitled "Tumor-localized CD40 agonism with MP0317, a FAPxCD40 DARPin, reprograms the tumor microenvironment - results of a Phase 1 monotherapy study", reports the positive results from the completed Phase 1 dose escalation study of MP0317. The comprehensive biomarker data confirm proof-of-mechanism for MP0317, including tumor-localized activation of the CD40 pathway and evidence of TME remodeling in patients with advanced solid tumors. MP0317 displayed a favorable safety profile up to the highest tested dose and serum pharmacokinetics confirmed suitability for dosing either weekly or every three weeks. Of the 46 patients in the study, one patient achieved an unconfirmed partial response and 14 patients stable disease in this heterogeneous population with advanced diseases. Data were presented at the 2024 Annual Meetings of the American Society of Clinical Oncology and of the Society for Immunotherapy of Cancer.

Molecular Partners announced the presentation of new preclinical data across three posters at the American Association for Cancer Research, AACR, Annual Meeting 2026. The first poster outlines preclinical data supporting proof-of-concept for MP0632, a logic-gated Switch-DARPin CD3 T cell engager with CD2 co-stimulation designed to selectively kill cells co-expressing mesothelin and epithelial cell adhesion molecule. MP0632 leads to regression of established tumors expressing both EpCAM and MSLN, with minimal impact on tumors expressing only one antigen, indicating a favorable therapeutic window. In addition, the Switch-DARPin candidate allowed for safe use of potent costimulation for efficient tumor cell killing with low cytokine release profile. The data support MP0632's potential as clinical lead candidate for the treatment of ovarian cancer and other MSLN- and EpCAM-positive solid tumors. The second poster presents a computational workflow to identify and prioritize tumor-associated antigen pairs for improved tumor-selectivity and safety in support of designing novel Switch-DARPin candidates, such as MP0632. This scalable, data-driven platform provides a strong foundation for the discovery of next-generation multispecific immunotherapies. The third poster outlines the molecular characteristics of MP0712, the Company's first 212Pb-based Radio-DARPin candidate, with high affinity binding to DLL3 and optimized half-life extended properties.

Molecular Partners announced it has entered into an agreement with Eckert & Ziegler to enable the development and manufacturing of Radio-DARPin therapeutics. Under the non-exclusive agreement, Eckert & Ziegler will support Molecular Partners with a range of services covering development activities for Radio-DARPins with Actinium-225 and Lutetium-177 payloads. The development agreement will leverage Eckert & Ziegler's laboratories, including its newly established Alpha Laboratory in Berlin, Germany, dedicated exclusively to work with alpha emitters.

Molecular Partners announced the presentation of first patient imaging and dosimetry data of MP0712, its DLL3-targeted Radio-DARPin candidate co-developed with strategic partner Orano Med, at the Theranostics World Congress, taking place in Cape Town, South Africa on January 29-February 1. The data, presented in two posters and an oral presentation, are supportive of the clinical development plans of MP0712 carrying the therapeutic isotope 212Pb for patients with small cell lung cancer and other DLL3-expressing neuroendocrine cancers. The data from five evaluable patients were generated with MP0712 carrying the diagnostic isotope 203Pb as part of a Named Patient Access Program under the legal framework for compassionate care in South Africa. The images show specific uptake as well as robust accumulation of MP0712 in tumor lesions, with limited uptake in healthy tissues, as intended. MP0712 is half-life engineered to promote tumor uptake over time via the DLL3 internalization and replenishment mechanism. Biodistribution of MP0712 in patients with various DLL3-expressing cancers, including small cell lung, urothelial, and other neuroendocrine cancers, provides a strong rationale for broad clinical development of MP0712 in SCLC and neuroendocrine cancers. The dosimetry extrapolations support the Phase 1/2a study design of MP0712 with 212Pb as therapeutic radioactive payload. The Phase 1/2a study of MP0712 is a multi-center study in the U.S., with the objectives to assess safety and determine a recommended phase 2 dose for MP0712 carrying the potent therapeutic isotope 212Pb. The study, which contains an imaging and dosimetry step with 203Pb-labeled MP0712, is ongoing with initial clinical data expected in 2026.