After Roche and Takeda, Novartis steps into the molecular glue space

Roche first entered into an agreement with Orionis Biosciences in 2023 and paid the company up to $2 billion to access its investigational glues targeting challenging goals in neurodegeneration and cancer. This was followed by Takeda’s deal with China’s Degron Therapeutics worth $1.2 billion, which was signed in May of this year for the latter’s molecular glues for inflammatory disease, cancer, and neuroscience targets.

Now, Novartis has stepped into the field with its collaboration with Monte Rosa, according to which the company will gain rights to Rosa’s VAV1-targeting molecular glue degraders for an upfront payment of $150 million.

The exclusive development and commercialization agreement includes an early-stage candidate, MRT-6160, the target protein for which is VAV1. VAV1 has been highlighted as a significant signaling protein involved in T- and B-cell cascades, and if deactivated, clinical studies have shown it can result in a major reduction of cytokines in the body. Without cytokines, the immune response in a person is severely compromised. The successful development of MRT-6160 means there is therapeutic potential for autoimmune and immune-mediated conditions.

Currently, MRT-6160 is going through Phase I single-ascending and multiple-ascending dose studies in healthy volunteers, and Novartis is only expected to take responsibility for it after Phase II. The candidate’s Phase III clinical development is expected to be co-funded by Monte Rosa as well.

Apart from the upfront payment, under the agreement, Monte Rosa is also entitled to up to $2.1 billion in regulatory and sale milestones as well as development. These payments are expected to start in Phase II of development. Within the context of the U.S., profits and losses associated with the manufacturing and sale of the candidate will be split between the two companies, and in the case of sales outside the U.S., Monte Rosa will be eligible for tiered royalties too.

Since the news of the collaboration has been made public, shares of Monte Rosa surged 32% to $6.46 in premarket trade. Given the fact that next year Novartis is expected to lose its patent protection for Entresto and Promacta, meant to treat a lack of blood platelets, access to MRT-6160 is meant to mitigate the impact of losing exclusivity on key medications and strengthen its drug pipeline. By focusing on fewer therapeutic areas and geographic markets, Novartis is trying to streamline its operations as much as possible.

President of Biomedical Research at Novartis, Fiona Marshall, has expressed great excitement over the Monte Rosa partnership and said, “We look forward to advancing MRT-6160 and learning more about its potential to provide a new therapeutic option for people living with a range of immune-mediated conditions.”

Molecular glues work by either binding to enzymes called ubiquitin ligase or by binding directly to the target protein. In the case of the former, it helps to tag specific proteins for degradation, while in the latter case, the ligase, with the help of its internal machinery, can destroy the specific disease-causing proteins after they are brought together by the actions of the molecular glue.

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