MOLN · Molecular Partners AG

Molecular Partners announced the peer-reviewed publication of positive Phase 1 monotherapy data for MP0317, a FAPxCD40 DARPin designed for tumor-localized CD40 activation to remodel the tumor microenvironment while minimizing systemic toxicities. The study (NCT05098405) in 46 patients with advanced solid tumors demonstrated proof-of-mechanism through comprehensive biomarkers, showing localized CD40 pathway activation and TME changes. Safety was favorable up to the maximum tested dose, with pharmacokinetics enabling flexible dosing schedules suitable for combinations like checkpoint inhibitors. Clinical activity included one unconfirmed partial response and stable disease in 14 patients across a heterogeneous population. These results, previously presented at ASCO and SITC 2024, support MP0317's advancement, particularly in combination settings. An ongoing investigator-initiated Phase 2 trial (NCT07036380) in front-line cholangiocarcinoma, combining MP0317 with durvalumab, gemcitabine, and cisplatin versus standard of care alone, has activated eight sites in France and is dosing patients toward 75 total (50 experimental arm). Coordinating investigator Philippe Cassier highlighted MP0317's ability to activate cold tumors without untargeted CD40 agonist toxicities, positioning it for immunotherapy combinations. This publication in a high-impact journal like Nature Cancer enhances credibility and de-risks further development of Molecular Partners' DARPin platform.