The molecular glue degrader medicines furthest along in development are potential cancer treatments, but Monte Rosa Therapeutics is also researching how this therapeutic modality can treat immunological disorders. Novartis sees promise in a Monte Rosa drug candidate designed to degrade a protein associated with autoimmune disease and the pharmaceutical giant is paying $150 million for global rights to the program.
The sum is an upfront payment for the molecule, named MRT-6160. Boston-based Monte Rosa is still responsible for completing the Phase 1 test underway. Under terms of the deal announced Monday, Novartis will take over development at Phase 2.
Monte Rosa’s R&D is part of a growing field that leverages a cellular system for disposing of old or damaged proteins as a way to eliminate disease-causing proteins. This targeted protein degradation relies on a molecular tag to mark a protein for disposal. For proteins that do not have a defined binding pocket for the molecular tag, a molecular glue can foster the interaction between the tag and the target protein. Monte Rosa addresses such difficult-to-target proteins with drugs called molecular glue degraders.
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MRT-6160 is a molecular glue degrader designed to target VAV1, a protein whose roles include the activation of two types of immune cells, T cells and B cells. Many autoimmune disorders are driven by excessive activity from these cells. By degrading VAV1, the Monte Rosa drug is intended to reduce the aberrant activity of those immune cells. At medical conferences this year, Monte Rosa has presented encouraging preclinical data for the drug in inflammatory bowel disease and rheumatoid arthritis. In August, Monte Rosa began a Phase 1 test of MRT-6160 in healthy volunteers. The company said preliminary data are expected in the first quarter of 2025.
Novartis already has a presence in targeted protein degradation in cancer from an earlier deal. In April, the Swiss pharma giant paid $150 million up front for an Arvinas degrader on track to Phase 3 testing in prostate cancer. Monte Rosa’s drug candidate gives Novartis a way to expand its protein degradation scope to autoimmune disease.
“Novartis has had a long-standing interest in molecular glue degraders, which offer the potential to tackle challenging biological targets,” Fiona Marshall, president of biomedical research at Novartis, said in a prepared statement. “We are excited about their application in immunology and the early progress we have seen by Monte Rosa in this space and with MRT-6160.”
Under the terms of the agreement with Novartis, Monte Rosa is eligible to receive up to $2.1 billion in milestone payments tied to the progress of MRT-6160. The deal also calls for the biotech to co-fund Phase 3 testing and share in the profits (or losses) associated with the manufacturing and commercialization of MRT-6160 in the U.S. The biotech would also receive royalties from Novartis’s sales of an approved product outside of the U.S.
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Monte Rosa’s most advanced program is MRT-2359, a molecular glue degrader in Phase 1/2 testing for cancers driven by MYC, a protein associated with cell proliferation and tumor growth. In Monday’s announcement, Monte Rosa CEO Markus Warmuth said the Novartis agreement provides the financial resources to extend the company’s cash runway and advance its pipeline to potential value-creating milestones and proof-of-concept readouts. More specific details will be provided in the company’s upcoming announcement of third quarter 2024 financial results.
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