- MRT-2359 received Fast Track designation from the FDA for the treatment of patients with previously treated, metastatic non-small cell lung cancer (NSCLC) with L-MYC or N-MYC expression
- Disclosure of initial data from Phase 1 arm of ongoing Phase 1/2 clinical trial evaluating MRT-2359 expected in second half of 2023
- Nomination of multiple additional development candidates anticipated in 2023
- Company to present pipeline and corporate updates at 41st Annual
J.P. Morgan Healthcare Conference onWednesday, Jan. 11, 2023 , at11:15 a.m. PT
“In 2022, we made significant progress across our portfolio of highly selective molecular glue degraders, culminating in the initiation of our Phase 1/2 trial of MRT-2359 in MYC-driven tumors,” said
2023 Key Milestones and Catalysts
- The
U.S. Food and Drug Administration (FDA) has granted Fast Track designation to MRT-2359 for the treatment of patients with previously treated, metastatic NSCLC with L-MYC or N-MYC expression - The company anticipates disclosing initial data from the Phase 1 arm of the ongoing Phase 1/2 clinical trial evaluating MRT-2359 in the second half of 2023
- The company anticipates the nomination of multiple development candidates in 2023 for its programs oncology, autoimmune and inflammatory diseases
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 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. By inducing degradation of GSPT1, MRT-2359 exploits this vulnerability, disrupting the protein synthesis machinery and leading to anti-tumor activity in MYC-driven tumors.
About the MRT-2359 Phase 1/2 study
Our ongoing Phase 1/2, open-label, multicenter study (Identifier: NCT05546268) will primarily assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary clinical activity of MRT-2359 in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL) and solid tumors with L-MYC or N-MYC amplification. In the Phase 1 portion of the study, patients will receive escalating doses of MRT-2359 to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Once the MTD and/or RP2D are determined, the anti-tumor activity of MRT-2359 will be assessed as part of the Phase 2 portion of the study, which includes L-MYC or N-MYC expression for stratification and selection.
About Monte Rosa
Forward-Looking Statements
This communication includes express and implied “forward-looking statements,” including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained in herein include, but are not limited to, statements about our product development activities, including our expectations around MRT-2359 and the potential significance of obtaining Fast Track Designation from the FDA, the ongoing development of our QuEEN™ platform and the advancement of our pipeline and the various products therein, our expectations regarding and the timing of our clinical trial for MRT-2359, our ability to initiate and the timing of initiation of additional lead optimization programs, and our expectations regarding our ability to nominate and the timing of our nominations of additional development candidates, as well as our expectations of success for our programs and the strength of our financial position, among others. By their nature, these statements are subject to numerous risks and uncertainties, including the impact that the ongoing COVID-19 pandemic will have on our development activities and operations, as well as those risks and uncertainties set forth in our most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K for the year ended
Contacts:
Investors
ir@monterosatx.com
Media
dan@1abmedia.com
![](https://ml.globenewswire.com/media/ZTgwYjczMGMtN2VkMi00NGFmLWJlOTQtMjc0NGYzNDZiZTQxLTEyMjEwOTg=/tiny/Monte-Rosa-Therapeutics-Inc-.png)
2023 GlobeNewswire, Inc., source