Monte Rosa Therapeutics Announces Initial Participants Dosed in First Phase of MRT-6160 Study
Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a biotechnology firm in the clinical stage concentrating on innovative molecular glue degrader (MGD)-based treatments, has announced that it has administered doses to the first participants in a Phase 1, single ascending dose/multiple ascending dose (SAD/MAD) study involving healthy volunteers. This trial is evaluating MRT-6160, an MGD aimed at VAV1, intended for treating systemic and neurological autoimmune conditions. The Company anticipates initial results from this Phase 1 trial by the first quarter of 2025.
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"We are thrilled to commence our Phase 1 clinical trial of MRT-6160, a highly selective, potent, and orally bioavailable VAV1-focused MGD, which we believe is the inaugural rationally designed MGD targeting a non-oncology indication," stated Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics.
"Our MGD-based therapeutic strategy is adept at targeting proteins that conventional methods struggle to address. We see promising opportunities to apply our technology to well-defined targets such as VAV1, which were previously deemed undruggable. By degrading VAV1, a crucial regulator of T- and B-cell receptor activities, MRT-6160 may provide a unique approach to treating various autoimmune and inflammatory diseases. The Phase 1 trial of MRT-6160 is structured to gather early data on safety, pharmacokinetics, VAV1 protein degradation, and essential downstream pharmacodynamic markers such as CD69, IL-2, IL-6, and IL-17. This data will guide our clinical strategy further. We are eager to share the initial clinical findings in Q1 2025 and to subsequently launch anticipated proof-of-concept studies in ulcerative colitis, rheumatoid arthritis, and possibly other conditions."
The progression of MRT-6160 is supported by preclinical data in various models of autoimmune/inflammatory diseases and preclinical GLP toxicology data, suggesting a unique therapeutic profile for T-cell, T/B-cell, and Th17-mediated systemic and neurological autoimmune diseases. MRT-6160 has demonstrated potent and selective degradation of VAV1 in vitro in human T and B cells and shown promising outcomes in multiple preclinical studies of autoimmune diseases, including inflammatory bowel disease, rheumatoid arthritis, and multiple sclerosis models.
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According to the data provided by the Synapse Database, As of August 21, 2024, there are 2 investigational drugs for the VAV1 target, including 4 indications, 1 R&D institution involved, and as many as 653 patents.
MRT-6160 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader of VAV1, which in preclinical studies has shown deep degradation of its target with no detectable effects on other proteins. VAV1, a Rho-family guanine nucleotide exchange factor, is a key signaling protein downstream of both the T- and B-cell receptors. VAV1 expression is restricted to blood and immune cells, including T and B cells. Preclinical studies have shown that targeted degradation of VAV1 protein via an MGD modulates both T- and B-cell receptor-mediated activity. This modulation is evident both in vitro and in vivo, demonstrated by a significant decrease in cytokine secretion, proteins vital for maintaining autoimmune diseases.
