MedPath

Monte Rosa Therapeutics

🇺🇸United States
Ownership
Public
Employees
133
Market Cap
$415.4M
Website
http://www.monterosatx.com

Clinical Trials

2

Active:0
Completed:0

Trial Phases

1 Phases

Phase 1:2

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (2 trials with phase data)• Click on a phase to view related trials

Phase 1
2 (100.0%)

First-in-human Study of MRT-6160 in Healthy Subjects

Phase 1
Recruiting
Conditions
Healthy Volunteers
Interventions
Drug: Placebo
First Posted Date
2024-09-19
Last Posted Date
2024-09-19
Lead Sponsor
Monte Rosa Therapeutics, Inc
Target Recruit Count
76
Registration Number
NCT06597799
Locations
🇺🇸

Celerion, Lincoln, Nebraska, United States

Study of Oral MRT-2359 in Selected Cancer Patients

Phase 1
Recruiting
Conditions
NSCLC
Prostate Cancer
HR-positive, HER2-negative Breast Cancer
DLBCL
L-MYC and N-MYC Amplified Solid Tumors
SCLC
High Grade Neuroendocrine Cancer
NSCLC With High or Low L-MYC or N-MYC Expression
Interventions
First Posted Date
2022-09-19
Last Posted Date
2025-02-17
Lead Sponsor
Monte Rosa Therapeutics, Inc
Target Recruit Count
174
Registration Number
NCT05546268
Locations
🇺🇸

Honor Health Research Institute, Scottsdale, Arizona, United States

🇺🇸

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States

🇺🇸

University of California San Diego, San Diego, California, United States

and more 16 locations

News

Monte Rosa's AI-Powered Discovery Engine Expands Molecular Glue Degrader Target Space in Science Publication

Monte Rosa Therapeutics published groundbreaking research on the cover of Science magazine, demonstrating how their AI and machine learning technologies have dramatically expanded the targetable protein space for molecular glue degraders.

Monte Rosa Therapeutics Receives FDA Clearance for MRT-8102, First NEK7-Targeted Molecular Glue Degrader for Inflammatory Diseases

Monte Rosa Therapeutics received FDA clearance for its Investigational New Drug application for MRT-8102, a NEK7-directed molecular glue degrader targeting inflammatory diseases driven by NLRP3 inflammasome and IL-1β dysregulation.

Monte Rosa Presents Promising Preclinical Data for CDK2 Molecular Glue Degrader in HR-Positive Breast Cancer at AACR 2025

Monte Rosa Therapeutics presented preclinical data at AACR 2025 showing their CDK2-directed molecular glue degrader MRT-51443 achieved superior tumor regression compared to standard care in HR-positive/HER2-negative breast cancer models.

Roche Expands Molecular Glue Portfolio with $2 Billion Monte Rosa Partnership

Roche has signed a $2 billion partnership with Monte Rosa Therapeutics, including a $50 million upfront payment, to develop molecular glue therapies targeting previously "undruggable" proteins in cancer and neurological diseases.

Monte Rosa Therapeutics Announces Key Milestones for Molecular Glue Degraders in 2025

• Monte Rosa Therapeutics anticipates Q1 2025 clinical data from its Phase 1 study of MRT-6160, a VAV1-directed molecular glue degrader for immune-mediated conditions. • The company expects to share additional Phase 1/2 results for MRT-2359 in Q1 2025, which targets MYC-driven solid tumors and has shown a favorable safety profile. • An IND application for MRT-8102, a NEK7-directed molecular glue degrader for inflammatory diseases, is on track for submission in the first half of 2025. • Monte Rosa's strong cash position, with $377 million expected as of December 31, 2024, is projected to fund operations into 2028.

NLRP3 Inhibitors Show Promise Across Autoimmune, Neurodegenerative, and Metabolic Diseases

• The NLRP3 protein inhibitors pipeline is robust, with over 20 companies developing more than 25 inhibitors targeting various inflammatory conditions. • NLRP3 inhibitors are being explored for treating neurodegenerative diseases like Alzheimer’s and Parkinson’s, as well as metabolic conditions such as NASH. • Clinical trials are underway, with companies like Novo Nordisk and NodThera reporting positive data on their NLRP3 inhibitor candidates. • Collaborations, such as the one between Halia Therapeutics and Biolexis Therapeutics, are advancing the development of brain-penetrant NLRP3 inhibitors for neuroinflammation.

Monte Rosa and Novartis Partner to Advance VAV1 Molecular Glue Degrader MRT-6160

• Monte Rosa Therapeutics and Novartis have entered an exclusive agreement to develop and commercialize VAV1 molecular glue degraders, including MRT-6160. • Novartis will gain worldwide rights for MRT-6160 development, manufacturing, and commercialization, commencing with Phase 2 studies, while Monte Rosa completes Phase 1. • MRT-6160, an orally bioavailable VAV1 degrader, has shown promise in preclinical models for various immune-mediated conditions by decreasing linked cytokines. • The agreement includes a $150 million upfront payment to Monte Rosa, with potential milestones reaching $2.1 billion, plus royalties on ex-U.S. sales.

Novartis and Monte Rosa Therapeutics Partner to Advance VAV1 Molecular Glue Degrader

• Novartis and Monte Rosa Therapeutics have entered into a global agreement to develop and commercialize VAV1 molecular glue degraders, including MRT-6160. • Monte Rosa will receive $150 million upfront and is eligible for up to $2.1 billion in milestone payments, plus royalties on ex-U.S. net sales. • MRT-6160, an orally bioavailable VAV1 degrader, is currently in Phase I trials for immune-mediated conditions and will transition to Novartis for Phase II development. • The collaboration aims to leverage molecular glue degraders to target proteins previously considered undruggable, offering new therapeutic options.

Novartis and Monte Rosa Therapeutics Partner to Advance VAV1 Degrader for Immune-Mediated Conditions

Novartis and Monte Rosa Therapeutics have entered into a global licensing agreement worth up to $2.1 billion to develop VAV1-directed molecular glue degraders.

Monte Rosa and Novartis Partner to Develop VAV1 Molecular Glue Degraders in $2.1B Deal

• Monte Rosa Therapeutics and Novartis AG have entered into a collaboration to develop molecular glue degraders (MGDs) targeting VAV1. • The deal includes MRT-6160, a phase I asset being studied in healthy volunteers for immune-mediated conditions, and is valued at $2.1 billion. • This collaboration aims to advance VAV1 MGDs for immune-mediated diseases, leveraging Monte Rosa's QuEEN platform and Novartis' expertise.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.