Monte Rosa Therapeutics Announces FDA Clearance of Investigational New Drug Application for MRT-2359, a GSPT1-directed Molecular Glue Degrader

– Phase 1/2 Clinical Trial in Patients with MYC-driven Solid Tumors Expected to Dose in Q4 2022 –

BOSTON, MA, USA I September 06, 2022 I Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for MRT-2359, a potent and selective GSPT1-directed MGD. The company is on track with initiating a Phase 1/2 clinical trial of MRT-2359 in patients with MYC-driven solid tumors, including lung cancer, and expects to dose the first patient in the fourth quarter of 2022.

“The FDA’s clearance of our first IND serves as a critical milestone for Monte Rosa and continues to validate our differentiated approach to protein degradation,” said Markus Warmuth, M.D., CEO of Monte Rosa. “Molecular glue degraders hold tremendous promise in tackling the universe of previously undruggable proteins and fostering a new generation of precision medicine therapeutics. After reporting compelling preclinical data, we are excited to advance MRT-2359 into a Phase 1/2 study for patients with MYC-driven solid tumors who otherwise have limited treatment options.”

About MRT-2359
MRT-2359 is a potent, selective and orally bioavailable molecular glue degrader (MGD) that induces the interaction between the E3 ubiquitin ligase component cereblon (CRBN) and the translation termination factor GSPT1, leading to the targeted degradation of GSPT1 protein. The MYC transcription factors (c‑MYC, L-MYC and N-MYC) are well-established drivers of human cancers that maintain high levels of protein translation, which is critical for uncontrolled cell proliferation and tumor growth. Our preclinical studies have shown that this addiction to MYC-induced protein translation creates a dependency on GSPT1. MRT-2359 exploits this vulnerability by inducing degradation of GSPT1, disrupting protein synthesis preferentially in MYC-driven cell lines and leading to anti-tumor activity in MYC-driven tumor models. A Phase 1/2 clinical study aims to evaluate the safety, tolerability and anti-tumor activity of MRT-2359.

About Monte Rosa
Monte Rosa Therapeutics is a biotechnology company developing a portfolio of novel molecular glue degrader (MGD) medicines. These medicines are designed to employ the body’s natural mechanisms to selectively eliminate therapeutically relevant proteins. The company has developed a proprietary protein degradation platform, called QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates), that enables it to rapidly identify protein targets and MGD product candidates that are designed to eliminate therapeutically relevant proteins in a highly selective manner. The company’s drug discovery platform combines diverse and proprietary chemical libraries of small molecule protein degraders with in-house proteomics, structural biology, AI/machine learning-based target selection, and computational chemistry capabilities to predict and obtain protein degradation profiles. For more information, visit www.monterosatx.com

SOURCE: Monte Rosa Therapeutics

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