On March 24, 2022 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 the publication of preclinical data from MP0317 in Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Molecular Partners, MAR 24, 2022, View Source [SID1234610918]). MP0317 is the Company’s second immuno-oncology program to enter clinical studies and is designed to target both FAP (fibroblast activation protein), a protein found in high density around tumors, and the immunostimulatory protein CD40, to enable tumor-localized immune activation.
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The CD40 receptor, which is expressed on dendritic cells, B cells and macrophages, is an attractive target for cancer immunotherapy. However, administration of CD40-targeting monoclonal antibodies has challenges with achieving a meaningful clinical response. Low concentrations result in minimal efficacy, but higher concentrations rapidly lead to systemic toxicity, limiting the therapeutic window achievable with systemic CD40 activation. The DARPin therapeutic candidate MP0317 is designed to specifically induce CD40-mediated immune activation only in the FAP-rich local tumor environment, preventing systemic immune activation.
The published study confirms that MP0317 is inducing FAP-dependent CD40-mediated B and myeloid cell activation, thus supporting the candidate intended mechanism of action of tumor-localized immune activation without the systemic toxicity observed with other CD40-targeting agents. This study suggests that MP0317, as a DARPin therapeutic candidate, has the potential for a broader therapeutic window and thus improved clinical activity compared to CD40 agonist antibodies. The publication can be found in this link.
MP0317 is currently being tested in a Phase 1 clinical trial sponsored by the Company. The open-label dose escalation study is designed to assess the safety and tolerability as well as pharmacokinetics and pharmacodynamics of MP0317 as a monotherapy in patients with solid tumors known to express FAP. In addition to evaluating monotherapy dynamics, the study will gather biomarker data to support the establishment of combination studies of MP0317 with other therapies in specific indications.
Initial data from the ongoing Phase 1 clinical trial are expected in the second half of 2022.