BOSTON, MA, USA I December 11, 2024 I Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced the closing of the Company’s previously announced global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160.

Under the terms of the agreement, Novartis will obtain exclusive worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1 MGDs and will be responsible for all clinical development and commercialization, starting with Phase 2 clinical studies. Monte Rosa remains responsible for completing the ongoing Phase 1 clinical study of MRT-6160.i Novartis has agreed to pay Monte Rosa $150 million up front. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies, as well as tiered royalties on ex-U.S. net sales. Monte Rosa will co-fund any Phase 3 clinical development and will share any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S.

MRT-6160 is a potent, highly selective, and orally bioavailable investigational degrader of VAV1, a key signaling protein downstream of both the T- and B-cell receptors. Preclinical studies have demonstrated deep degradation of VAV1, resulting in a significant decrease in cytokines linked to immune-mediated conditions, with no detectable effects on other proteins. MRT-6160 has shown promising activity in preclinical models of multiple immune-mediated conditions.ii,iii

About Monte Rosa
Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to identify degradable protein targets and rationally design MGDs with unprecedented selectivity. The QuEEN discovery engine enables access to a wide-ranging and differentiated target space of well-validated biology across multiple therapeutic areas. Monte Rosa has developed the industry’s leading pipeline of MGDs, which spans oncology, autoimmune and inflammatory disease and beyond. Monte Rosa has a global license agreement with Novartis to advance VAV1-directed molecular glue degraders and a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug. For more information, visit www.monterosatx.com.

i Details about the study, MRT-6160 in a First-in-human Study in Healthy Subjects, can be found at ClinicalTrials.gov under the identifier NCT06597799.
ii Cartwright A et al. MRT-6160, a VAV1-Directed Molecular Glue Degrader, Reduces Joint Inflammation
and Autoantibody Production in a Collagen-Induced Arthritis Autoimmune Disease Model. Poster presented at: Digestive Disease Week 2024; May 21, 2024; Washington, DC.
iii Cartwright A et al. MRT-6160, a VAV1-Directed Molecular Glue Degrader, Inhibits Disease Progression in a T-cell Transfer Mediated Colitis Model Concomitant with Reduced Calprotectin Expression. Poster presented at: EULAR 2024 – Annual European Congress of Rheumatology; June 14, 2024; Vienna, Austria.

SOURCE: Monte Rosa Therapeutics