Announcement • Jul 16
Molecular Partners AG Announces Clinical Progress In Phase 2 TACTIC Combination Trial Of MP0317 For Patients With Cholangiocarcinoma Molecular Partners AG announced the dosing of first patients in an investigator-initiated Phase 2 proof-of-concept study of MP0317 in combination with chemoimmunotherapy in first line treatment for patients with advanced biliary tract carcinoma (TACTIC), also known as cholangiocarcinoma. The randomized, multicenter TACTIC study (NCT07036380) in France aims to recruit 75 patients, with a 2-to-1 design, with 50 patients in the experimental arm and 25 in the control arm. The objective of the study is to assess the clinical benefit of MP0317 combined with standard-of-care comprising the immunotherapy durvalumab, an anti-PD-L1 checkpoint inhibitor, plus gemcitabine-cisplatin-based chemotherapy, compared to standard-of-care alone in frontline setting. Nine expert trial sites are now activated and patient treatment is ongoing. A data update from the trial is expected in 2027, and completion of the study in 2028. A trial-in-progress poster on the MP0317 Phase 2 study has been accepted for presentation at the European Society for Medical Oncology Congress 2026, taking place October 23-27 in Madrid, Spain. MP0317, a FAP-localized CD40 agonist designed to drive immune-mediated remodeling of the tumor microenvironment, is hypothesized to improve 12-month progression-free survival rate of patients with advanced cholangiocarcinoma compared to standard-of-care alone. The tumor microenvironment is known to play a crucial role in the development of cholangiocarcinoma and other solid tumors, as well as in their treatment resistance. Molecular Partners AG completed a Phase 1 dose-escalation study of MP0317 in patients with advanced solid tumors with 46 patients treated across 9 dose levels. Comprehensive biomarker analyses from the trial showed tumor-localized CD40 activation and tumor microenvironment remodeling as intended by design. The results of this Phase 1 study were recently published in Nature Cancer (Steeghs et al. 2026; DOI: 10.1038/s43018-026-01150-1). Announcement • Jul 15
Molecular Partners Showcases Bispecific Radio-DARPins Molecular Partners AG highlighted its approaches to overcoming target limitations in radioligand therapy (RLT) through Radio-DARPins, in a presentation at the Gordon Research Conference Radionuclide Theranostics for the Management of Cancer in Newry, Maine, US. The presentation outlines the ability of DARPins to match the biological characteristics of both the target and the disease, by optimizing their binding properties, systemic half-life, and biodistribution. To address tumor heterogeneity, Molecular Partners is also developing multispecific Radio-DARPins that can engage multiple tumor targets simultaneously, improving precision and therapeutic efficacy. Building on the success of its first “mono”-targeting Radio-DARPins, the Company is highlighting the ability to expand its impact in the field of RLT through multispecific DARPins. These can be formatted either as a bispecific (two DARPins each binding an individual target) or as a 2-in-1 DuoDARPin (one DARPin able to bind two tumor targets in an either/or manner). The Company’s multispecific approaches enable the design of radiopharmaceuticals for effective treatment of highly heterogenous cancers, with target expression variability across tumor lesions and patients. Such bispecific radiopharmaceuticals could allow to treat cancer indications in which two targets are co-expressed solely on tumor tissues, creating tumor-specific solutions for patients with limited therapeutic options. Molecular Partners’ lead Radio-DARPin candidate MP0712, co-developed with Orano Med and targeting delta-like ligand 3 (DLL3), is in a multicenter US Phase 1/2a trial, building on the successful generation of first imaging and dosimetry data from a compassionate care program. The second candidate MP0726, targeting mesothelin MSLN, is differentiated by its ability to selectively bind membrane-bound MSLN, and work towards first human imaging is expected this year. Molecular Partners expects to announce a third Radio-DARPin program, targeting a different tumor target, in 2026. Molecular Partners develops targeted alpha therapeutics leveraging its Radio-DARPins as isotope-agnostic vectors with the potential to unlock a broad range of cancer targets and indications. Molecular Partners designs its Radio-DARPin candidates matching disease and target biology with vector and isotope properties to address unmet medical needs. Building on the DARPins’ unique properties, Molecular Partners has developed a proprietary Radio-DARPin platform for precise delivery of potent radioactive payloads to tumor lesions. Molecular Partners’ Radio-DARPins address historic limitations of radioligand therapy, such as kidney accumulation and suboptimal tumor uptake, through optimized half-life extension and surface engineering approaches, while preserving the advantages of the small protein format. Molecular Partners has established partnerships with industry leaders covering the full value chain for the development of its Radio-DARPin therapeutics, including a strategic collaboration with Orano Med – pioneer in the development of 212Pb-based targeted alpha therapies (TAT), a non-exclusive development agreement with Eckert & Ziegler – global leader in radiopharmaceutical manufacturing, and a supply agreement with PanTera – a leading 225Ac radioisotope producer. Announcement • Jul 06
Molecular Partners Provides Update on Clinical Progress Across Pipeline of Darpin Radiotherapeutics Molecular Partners has made significant progress in the first months of 2026, with its DLL3 radiotherapy candidate MP0712 progressing through Phase 1 initiation and dosing of patients in the first cohort. Dosing of patients is ongoing in the first cohort of the US multicenter Phase 1/2a study of MP0712 (ClinicalTrials.gov: NCT07278479). MP0712, targeting the tumor-associated protein delta-like ligand 3 (DLL3) and carrying the therapeutic payload Lead-212 (212Pb), is being developed for patients with small cell lung cancer and other neuroendocrine cancers, with strategic partner Orano Med. The Phase 1 study contains up to 4 dose levels (cohorts). Each patient will receive up to 4 doses of MP0712 within their assigned dose level. At present five centers are open and recruiting. Initial data from the MP0712 Phase 1/2a study are expected within the next months, with a more comprehensive dataset on safety and efficacy in 2027. Additional compassionate care work has been initiated by the Nuclear Medicine Research Institute in South Africa utilizing 225Ac-loaded DLL3 Radio-DARPin, highlighting the versatility of DARPins as isotope agnostic vectors. Dr. Mike Sathekge of the Nuclear Medicine Research Institute (NuMeRI) in South Africa has made a request for an early-access clinical program (under the legal framework for compassionate care in South Africa, Section 21 of the Medicines and Related Substances Act) with a DLL3-targeting Radio-DARPin, this time utilizing 177Lu/225Ac as theranostics pair to image and treat patients, respectively (referred to as MP0714). PanTera, a radioisotope producer, is among the suppliers of 225Ac for the use of MP0714 at NuMeRI. The Company’s ability to explore targets in an alpha isotope-agnostic manner is supported by preclinical data presented at the 3rd Global Radiopharmaceuticals Development Summit in March 2026 in Shanghai, China. The data show highly comparable biodistribution profiles of two Radio-DARPin candidates, each specific for a different tumor target, labeled with 177Lu or 203Pb. Imaging with 177Lu can be indicative of behavior with the therapeutic isotope 225Ac, and similarly with 203Pb for 212Pb. MP0726, the Company’s second Radio-DARPin candidate, targets mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need such as ovarian cancer. Molecular Partners plans to advance MP0726 towards first-in-human imaging in H2 2026. As part of its growing pipeline, the Company plans two INDs across its portfolio of targeted cancer therapeutics in 2027 and expects to nominate a new RDT target in the second half of this year. Molecular Partners develops targeted alpha therapeutics leveraging its Radio-DARPins as isotope-agnostic vectors with the potential to unlock a broad range of cancer targets and indications. Molecular Partners designs its Radio-DARPin candidates matching disease and target biology with vector and isotope properties to address unmet medical needs. Building on the DARPins’ unique properties, Molecular Partners has developed a proprietary Radio-DARPin platform for precise delivery of potent radioactive payloads to tumor lesions. Molecular Partners’ Radio-DARPins address historic limitations of radioligand therapy, such as kidney accumulation and suboptimal tumor uptake, through optimized half-life extension and surface engineering approaches, while preserving the advantages of the small protein format. Molecular Partners has established partnerships with industry leaders covering the full value chain for the development of its Radio-DARPin therapeutics, including a strategic collaboration with Orano Med – pioneer in the development of 212Pb-based targeted alpha therapies (TAT), a non-exclusive development agreement with Eckert & Ziegler – global leader in radiopharmaceutical manufacturing, and a supply agreement with PanTera – a radioisotope producer. 
