On January 08, 2023 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported several developments in its infectious disease and oncology portfolios (Press release, Molecular Partners, JAN 8, 2023, View Source [SID1234626011]). These include:
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DARPin Radioligand Therapy platform progressing well. Disclosure of the tumor-associated protein Delta-like ligand 3 (DLL3) as the first target. Expression of DLL3 is low in healthy tissue but significantly increased in certain tumor types, providing an opportunity for selective targeting.
Year-end 2022 unaudited cash and short-term deposits ~CHF249m. Company continues to maintain expected cash runway into 2026.*
Molecular Partners and Novartis signed a non-binding letter of intent to negotiate a Research Framework Agreement with a primary focus on emerging infectious global health threats. The Parties agree that the Definitive Agreement if concluded, shall contain provisions covering research plans, governance, development and commercialization, intellectual property, and the potential to prioritize future pandemic projects
The company expects milestones in 2023 to include:
Q1 2023: The recruitment of the first patient in the company’s phase 1 study of MP0533 (CD33 X CD123 X CD70 X CD3), a novel tri-specific t-cell engager for the treatment of AML and High Risk MDS
1H 2023: Complete recruitment in the dose escalation of the Phase 1 trial of the company’s MP0317 (FAP X CD40) program for the treatment of solid tumors
H1 2023: Scientific presentations of DARPin radioligand therapies and their potential differentiation as tumor targeting moiety
Formal selection of DLL3 DARPin RLT clinical candidate
Q4 2023: A first data readout from the Phase 1 study of MP0533
Ensovibep Update:
Molecular Partners was informed by its partner Novartis that it has submitted a request to withdraw the Emergency Use Authorization (EUA) application from the U.S. Food and Drug Administration (FDA) for ensovibep, a DARPin therapeutic candidate to treat COVID-19.
As previously disclosed, ensovibep is not presently in clinical development.
Patrick Amstutz, CEO of Molecular Partners, will present at the 41st Annual JP Morgan Healthcare Conference on Wednesday, January 11 at 10:30 AM ET (4:30 PM CET). A webcast will be accessible on the Molecular Partners website, under the Events tab.
*Unaudited financials. YE audited results will be available March 9, 2023