Molecular Partners reports Phase 1 MP0317 data and Phase 2 trial start

Molecular Partners AG announced the publication of Phase 1 clinical data for MP0317, a tumor-localized CD40 agonist, in Nature Cancer. The study (NCT05098405) evaluated MP0317 in 46 patients with advanced solid tumors, demonstrating a favorable safety profile and proof-of-mechanism for tumor-localized CD40 activation via fibroblast activation protein (FAP) anchoring. Results showed evidence of tumor microenvironment (TME) remodeling, with one unconfirmed partial response and 14 instances of stable disease. The pharmacokinetic profile supports weekly or every-three-week dosing, making it suitable for combination therapies. Following these positive results, a randomized Phase 2 investigator-initiated trial (NCT07036380) has commenced. This multicenter study in France will evaluate MP0317 in combination with standard-of-care (durvalumab plus gemcitabine-cisplatin) versus standard-of-care alone in 75 patients with front-line advanced cholangiocarcinoma. The Phase 2 study aims to assess clinical benefits, specifically focusing on improving the 12-month progression-free survival rate by leveraging MP0317's ability to modulate the TME.