Novartis Partner Monte Rosa Therapeutics Touts Positive Data From Early-Stage Study Of Investigational Drug Candidate For Immune-Mediated Disorders

Monte Rosa Therapeutics Inc. GLUE on Thursday revealed clinical results from its MRT-6160 Phase 1 single ascending dose/multiple ascending dose (SAD/MAD) study.

The study objectives were to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics, including VAV1 degradation and its impact on T and B cell function following ex vivo stimulation.

Results demonstrated sustained, dose-dependent VAV1 degradation of greater than 90% in peripheral blood T cells after single and multiple dose administration. Similar results were observed in peripheral blood B cells.

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Sustained suppression of TCR-mediated T and B cell activation measured by CD69 was observed following single and multiple dose administration and ex vivo activation of whole blood.

• MRT-6160 also inhibited the secretion of inflammatory cytokines by up to 99% from whole blood-derived T cells following ex vivo activation of TCR. It demonstrated significant and sustained attenuation of IL-6 production across dose levels following B cell stimulation.
• The administration of MRT-6160 was generally well-tolerated, and no serious adverse effects were observed.
• The current Phase 1 data and chronic toxicology package support a clear path into anticipated Phase 2 studies and broad potential applications in multiple immune-mediated diseases.

Further development of MRT-6160 toward Phase 2 studies is ongoing in collaboration with Novartis AG NVS.

In October 2024, Monte Rosa Therapeutics announced a global exclusive development and commercialization license agreement with Novartis to advance VAV1 MGDs, including MRT-6160.

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.

The company says cash, cash equivalents, restricted cash and marketable securities as of Dec. 31, 2024, of $377 million is expected to provide a cash runway into 2028.

GLUE Price Action: Monte Rosa Therapeutics stock is up 5.11% at $7.04 at publication Thursday.

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