Monte Rosa Therapeutics Inc (NASDAQ:GLUE) stock is trading higher on Monday after the company announced a global exclusive development and commercialization license agreement with Novartis AG (NYSE:NVS) to advance VAV1 MGDs, including MRT-6160.
MRT-6160 is currently in an ongoing Phase 1, single ascending dose (SAD)/multiple ascending dose (MAD) healthy volunteer study for immune-mediated conditions.
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 studies.
Novartis has agreed to pay Monte Rosa $150 million upfront. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies, and tiered royalties on ex-U.S. net sales.
Monte Rosa will co-fund any Phase 3 clinical development and share any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S.
Monte Rosa remains responsible for completing the ongoing Phase 1 clinical study of MRT-6160.
In August, Monte Rosa Therapeutics dosed the first patient in the Phase 1 SAD/MAD study of MRT-6160. The company expects to obtain initial data from the Phase 1 study in the first quarter of 2025.
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 activity in preclinical models of multiple immune-mediated conditions.
Monte Rosa plans to provide further information regarding its updated cash position and runway in its third quarter 2024 earnings update.
Price Action: GLUE stock is up 30.1% at $6.35 during the premarket session at last check Monday.
Photo via Shutterstock
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