Molecular Partners AG

Molecular Partners has dosed the first patients in an investigator-initiated Phase 2 proof-of-concept study of MP0317 combined with chemoimmunotherapy for first-line treatment of advanced biliary tract carcinoma. The randomized, multicenter TACTIC study in France aims to recruit 75 patients, with 50 in the experimental arm receiving MP0317 plus standard-of-care durvalumab and gemcitabine-cisplatin chemotherapy, and 25 in the control arm receiving standard-of-care alone. Nine trial sites are now active and patient treatment is ongoing, with a data update expected in 2027 and trial completion in 2028. A trial-in-progress poster will be presented at the ESMO Congress 2026 in October. MP0317 is a FAP-localized CD40 agonist designed to remodel the tumor microenvironment, and the company believes it could improve 12-month progression-free survival in this setting.

Molecular Partners highlighted its bispecific Radio-DARPin approaches at the Gordon Research Conference on Radionuclide Theranostics for the Management of Cancer. The presentation outlined how DARPins can be engineered to match target and disease biology, and the company is developing multispecific Radio-DARPins that engage multiple tumor targets simultaneously to address tumor heterogeneity. These can be formatted as bispecific molecules with two DARPins each binding an individual target, or as a 2-in-1 DuoDARPin where one DARPin binds two tumor targets in an either/or manner. Molecular Partners' lead Radio-DARPin candidate MP0712, co-developed with Orano Med and targeting DLL3, is in a multicenter US Phase 1/2a trial, while a second candidate MP0726 targets mesothelin MSLN and is expected to generate first human imaging data this year. A third Radio-DARPin program targeting a different tumor target is expected to be announced in 2026.

Molecular Partners plans to advance MP0726 towards first-in-human imaging in the second half of 2026. The company also provided an update on MP0712, noting that patient dosing is ongoing in the first cohort of a US multicenter Phase 1/2a study, with initial data expected within the next few months and a more comprehensive dataset on safety and efficacy expected in 2027. Additionally, Molecular Partners intends to file two INDs for targeted cancer therapeutics in 2027 and nominate a new RDT target in the second half of 2026. As of March 31, 2026, the company held CHF 79 million in cash and cash equivalents, which it believes will fund operations into late 2027.

Molecular Partners and Orano Med announced that the first patients have been dosed in the US multicenter Phase 1/2a study of MP0712, a DLL3-targeting Radio-DARPin carrying the therapeutic payload lead-212. The study is currently recruiting at five US sites, with additional sites planned to open this year, and dosing is ongoing in cohort 1 with patients moving to repeat dosing. MP0712 targets DLL3, a protein expressed in over 85% of small cell lung cancer tumors and other aggressive neuroendocrine tumors, while expression in healthy tissues is low. The trial employs a matched-pair approach using a diagnostic imaging agent with 203Pb-labeled MP0712 to predict tumor uptake before patients receive up to four doses of 212Pb-labeled MP0712 across up to four dose levels. Initial data are expected in the coming months, with comprehensive safety and efficacy data anticipated in 2027.