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

  • Second immuno-oncology DARPin candidate to enter the clinic; combines immune stimulation with validated tumor-localizing technology
  • Preclinical data support potential to deliver tumor-localized immune activation while avoiding systemic toxicity seen with other CD40-targeting agents

ZURICH-SCHLIEREN, Switzerland and CONCORD, MA, USA I November 04, 2021 IMolecular 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.

About Molecular Partners’ Immuno-oncology Product Candidates
Molecular Partners is developing several candidates designed to activate the immune system to fight cancer while reducing damage to healthy cells. These candidates use multiple novel DARPin technologies potentially applicable against a wide range of tumor types, including DARPin candidates with the ability to restrict immune activation to the tumor microenvironment, the ability to target intracellular disease-associated proteins, and multiple novel control mechanisms for immune activation designed to direct immune attack to the right cells, at the right place, and at the right time. These capabilities can be combined during candidate design through the inherent modularity of the DARPin platform, to provide precise control over immune activation and potentially enable more effective cancer immunotherapies.

About Molecular Partners AG 
Molecular Partners AG is a clinical-stage biotech company developing DARPin therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin therapeutics in the areas of infectious disease, oncology and ophthalmology, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. www.molecularpartners.com; Find us on Twitter - @MolecularPrtnrs

1. AACR 2021, Poster 1733 - MP0317, a CD40xFAP targeting multi-specific DARPin® therapeutic, drives immune activation and reverts myeloid-mediated T-cell suppression in vitro and ex vivo

SOURCE: Molecular Partners

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