Monte Rosa and Novartis Sign Global License for VAV1-targeted Molecular Glue Degraders

Monte Rosa Therapeutics, Inc., a biotech company in the clinical stage of development, has announced a significant global partnership with Novartis to develop and commercialize molecular glue degraders (MGDs), particularly focusing on VAV1 MGDs like MRT-6160. This collaboration aims to expedite the clinical development of MRT-6160, which is currently undergoing a Phase 1 study involving healthy volunteers to evaluate single ascending and multiple ascending doses for immune-mediated conditions. This agreement grants Novartis exclusive worldwide rights to the development, manufacturing, and commercialization of MRT-6160 and other related VAV1 MGDs, with Novartis assuming responsibility starting from Phase 2 clinical trials. Monte Rosa will continue to oversee the ongoing Phase 1 study.

Monte Rosa Therapeutics will receive an upfront payment of $150 million from Novartis and has the potential to earn up to $2.1 billion in milestone payments across development, regulatory, and sales phases, in addition to tiered royalties from sales outside the U.S. The two companies will share the development costs and profits associated with MRT-6160 in the U.S. This financial arrangement is anticipated to bolster Monte Rosa’s resources, enabling further advancement of their pipeline and supporting their operational runway towards achieving future milestones and proof-of-concept outcomes.

The CEO of Monte Rosa, Markus Warmuth, M.D., expressed enthusiasm about the partnership, highlighting the opportunity to accelerate and expand the development of MRT-6160. He emphasized the validation of Monte Rosa's QuEEN™ discovery engine, which utilizes AI-guided chemistry, structural biology, and proteomics to design highly selective and safe MGDs. This collaboration is expected to enhance Monte Rosa’s ability to develop treatments for previously undruggable targets across various therapeutic areas, including immunology, inflammation, metabolism, and genetic diseases.

Fiona Marshall, President of Biomedical Research at Novartis, underscored Novartis' long-standing interest in MGDs and their potential to address difficult biological targets, particularly in the field of immunology. Marshall expressed optimism about MRT-6160's early progress and potential as a new therapeutic option for patients with immune-mediated conditions. Novartis is committed to advancing MRT-6160 to meet unmet medical needs and explore new treatment possibilities for affected patients.

MRT-6160 is designed as a potent, selective, and orally bioavailable investigational degrader of VAV1, a crucial signaling protein in T- and B-cell receptors. Preclinical studies have shown that MRT-6160 effectively degrades VAV1, significantly reducing cytokines associated with immune-mediated disorders without impacting other proteins. The preclinical models indicate promising activity in treating various immune-mediated conditions.

The agreement between Monte Rosa and Novartis is subject to standard closing conditions, including regulatory approval. Monte Rosa anticipates providing further updates on its financial status and operational runway in its third-quarter earnings report for 2024.

Monte Rosa Therapeutics focuses on developing molecular glue degrader medicines. Their QuEEN™ discovery engine, which combines advanced technologies, allows for the identification and design of MGDs with high selectivity. Monte Rosa’s robust pipeline includes treatments for oncology, autoimmune, and inflammatory diseases. The company maintains a strategic collaboration with Roche for developing MGDs against cancer and neurological diseases.