Shares of Monte Rosa Therapeutics Inc. (NASDAQ: GLUE) surged over 30% in premarket trading on Monday after the company announced a significant global partnership with pharmaceutical giant Novartis AG (NYSE: NVS). The deal involves the exclusive development and commercialization of Monte Rosa’s VAV1 MGDs, including its lead drug candidate MRT-6160.
This agreement grants Novartis worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1 MGDs. The Swiss pharmaceutical giant will be responsible for all clinical development and commercialization, starting with Phase 2 studies. To secure these rights, Novartis has committed to pay Monte Rosa an upfront payment of $150 million.
The deal also includes potential milestone payments for Monte Rosa, totaling up to $2.1 billion, upon the achievement of various development, regulatory, and sales milestones. These payments will begin with the initiation of Phase 2 studies. Monte Rosa will also receive tiered royalties on ex-U.S. net sales of MRT-6160.
While Novartis takes the lead on global development and commercialization, Monte Rosa will co-fund any Phase 3 clinical development in the U.S. and share any profits or losses associated with the manufacturing and commercialization of MRT-6160 within the U.S. Monte Rosa retains responsibility for completing the ongoing Phase 1 clinical study of MRT-6160, which is currently evaluating the drug in healthy volunteers for its potential to treat immune-mediated conditions.
The company expects to receive initial data from this Phase 1 study in the first quarter of 2025.
Targeting a Key Immune Signaling Protein
MRT-6160 is a highly selective, orally bioavailable investigational degrader of VAV1. VAV1 is a crucial signaling protein that plays a role downstream of both T- and B-cell receptors, which are essential components of the immune system. Preclinical studies have demonstrated that MRT-6160 effectively degrades VAV1, leading to a significant decrease in cytokines associated with immune-mediated conditions. Importantly, these preclinical studies have shown that MRT-6160 exhibits no detectable effects on other proteins. This targeted action suggests a potential for MRT-6160 to treat a range of immune-mediated conditions with minimal side effects.
A Promising Future in Immune-Mediated Diseases
MRT-6160 has shown promising activity in preclinical models of multiple immune-mediated conditions, highlighting its potential for treating a wide range of diseases. This deal with Novartis underscores the significant potential of MRT-6160 and Monte Rosa’s novel approach to targeting VAV1.
The substantial upfront payment from Novartis and the potential for significant milestone payments and royalties indicate confidence in the drug’s potential. With Novartis’ expertise in global pharmaceutical development and commercialization, this partnership could pave the way for MRT-6160 to reach patients who may benefit from its targeted approach to treating immune-mediated conditions.
Monte Rosa Therapeutics plans to provide further details regarding its updated cash position and projected runway in its third quarter 2024 earnings update.
