Molecular Partners: Expanding Radiopharma Pipeline and Strengthening Strategic Focus in 2025

Molecular Partners, a clinical-stage biotech company specializing in DARPin therapeutics, has outlined its clinical expansion plans and strengthened its radiopharmaceutical strategic focus for 2025 at the 43rd Annual J.P. Morgan Healthcare Conference. The company's updates highlight key developments in its Radio-DARPin and Switch-DARPin programs, as well as its financial position.



Molecular Partners has expanded its strategic partnership with Orano Med, ensuring access to 212Pb for up to 10 products. The company is co-developing up to 10 212Pb-based Radio-DARPins with Orano Med, with commercialization rights to the most advanced program, MP0712, and the second nominated candidate targeting Mesothelin (MSLN). Orano Med will produce the 212Pb-based Radio-DARPins for clinical trials and commercialization.

MP0712, the most advanced Radio-DARPin targeting DLL3, is moving into clinical development in 2025. The company anticipates submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in H1 2025, with the first-in-human study to follow regulatory clearance. Preclinical results for MP0712 have shown high affinity and specificity for DLL3, a highly relevant target for radiopharmaceutical therapy with homogeneous expression in small cell lung cancer tumors and low expression in healthy tissues.

Molecular Partners has selected Mesothelin as the second target in its Orano Med partnership. The company has developed unique DARPin binders that selectively bind to the membrane-proximal portion of MSLN present on cells, making them less susceptible to the high shedding of MSLN that has historically hampered the development of therapeutics against this target. This approach allows for more effective targeting of MSLN-expressing cancers, such as ovarian cancer, with potentially improved treatment outcomes.

The company's MP0533 candidate in relapsed or refractory acute myeloid leukemia (AML) has shown encouraging results in cohort 8, with improved response rates and depth using a steeper step-up and more frequent dosing strategy. Additional dose densification is planned for cohort 9, with updates expected in 2025. The CD3 Switch-DARPin platform has demonstrated proof-of-concept in solid tumors, showing conditional T cell activation and CD2 co-stimulation, with further data expected in Q2 2025.

Molecular Partners reported cash and cash equivalents of CHF 149 million as of December 31, 2024, providing an estimated 18-24 month runway for key clinical milestones through 2025-2026. The multiple catalysts expected in 2025, including MP0533 data and Radio-DARPin program advancement, could drive significant value creation for the company.

In conclusion, Molecular Partners' clinical expansion plans and strengthened radiopharmaceutical strategic focus for 2025 demonstrate the company's commitment to advancing its DARPin therapeutic platform and expanding its pipeline. The expanded Orano Med partnership, key clinical milestones for MP0712 and MP0533, and the unique DARPin approach to targeting Mesothelin position the company well for future growth and success in the biopharmaceutical industry.