Monte Rosa Shares Rise As FDA Announced Clearance To MYC-Driven Cancer Study

The U.S. Food and Drug Administration (FDA) has announced clearance to Monte Rosa Therapeutics’ GLUE investigational new drug application (IND) for its drug candidate MRT-2359 in patients with MYC-driven solid tumors.

The Phase 1/2 clinical trial will evaluate MRT-2359 in patients with MYC-driven solid tumors, including lung cancer.

MRT-2359 is a potent, selective and orally bioavailable GSPT1-directed molecular glue degrader (MGD).

Markus Warmuth, Chief executive officer, said, "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. 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.”

The company is  planning to initiate patient dosing in the fourth quarter of 2022.

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.

Price Action : Monte Rosa shares are trading around 3 percent higher at $8.33 on Tuesday at the time of publication.