Molecular Partners Announces First Patient Dosed with CD40 Therapeutic Candidate MP0317 in Phase 1 Clinical Trial

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) — 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, today announced dose administration for the first patient in a Phase 1 first-in-human study evaluating the safety and tolerability of MP0317, which targets both the fibroblast activation protein (FAP) and the immunostimulatory protein CD40 to enable tumor-localized immune activation. MP0317 is the second DARPin therapeutic candidate in the company’s immuno-oncology pipeline to enter clinical trials. Through this mechanism of action, MP0317 is designed to activate immune cells specifically within the tumor microenvironment, potentially delivering greater efficacy with fewer side effects compared to other CD40-targeting agents.

“The multispecificity afforded by DARPin technology allows us to design novel immuno-oncology candidates with additional control mechanisms for greater specificity and reduced systemic toxicity compared to monoclonal antibodies and other approaches,” said Nicolas Leupin, M.D., Ph.D., Chief Medical Officer of Molecular Partners. “Having previously demonstrated the ability of FAP-dependent tumor-localized immune engagement in our MP0310 program, we are excited to see how this mechanism translates to patient benefit in our second immuno-oncology program. MP0317 represents another step in the evolution of our DARPin platform to deliver increasingly sophisticated candidates that can potentially direct immune attack to the right cells, at the right place, and at the right time.”

Preclinical data from MP0317 in human tumor samples show that it activates B-cells, dendritic cells and macrophages, and induces a broad range of pro-inflammatory activities, including macrophage repolarization and reversion of T‑cell suppression. The multispecific design of MP0317 is expected to ensure that activation of CD40 will only occur in the presence of FAP, which is highly expressed in the connective tissue of a broad range of solid tumors. As previously presented1, the anti-tumor effect induced by MP0317 was comparable to that achieved by an anti-CD40 antibody. The Company believes these data support MP0317’s potential to deliver tumor-localized CD40-mediated immune cell activation while avoiding the systemic toxicity seen with other CD40-targeting agents.

The open-label dose escalation study announced today 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 and CD40. Enrollment will take place in the Netherlands and France. Up to 30 patients are expected to be enrolled across six dosing cohorts and up to 15 patients dosed in a dose expansion cohort. Patients will be dosed every three weeks. In addition to evaluating monotherapy dynamics, the study will gather a wide variety of biomarker data to support the establishment of combination therapies with MP0317 in specific indications.

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