Phase 1/2 clinical trial of MRT-2359 in MYC-driven solid tumors on track; recommended Phase 2 dose (RP2D) expected in Q2 2024
Received US FDA Fast Track Designation for MRT-2359 for previously treated, metastatic small cell lung cancer with L- or N-MYC expression
MRT-6160, a VAV1-directed MGD, anticipated to initiate Phase 1 study in mid-2024, supporting potential future Phase 2 proof-of-concept studies in multiple autoimmune diseases
Strong cash position expected to fund operations into H1 2026 and enable advancement of pipeline programs through significant early clinical milestones
Company to present at J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024, at 3:00 p.m. PT
BOSTON, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics (NASDAQ:GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today outlined anticipated 2024 milestones ahead of its participation in the 42nd Annual J.P. Morgan Healthcare Conference. The company's presentation, taking place on Wednesday, January 10, 2024, at 3:00 p.m. PT, will focus on strategic priorities for 2024, including anticipated progress with the ongoing Phase 1/2 clinical trial of MRT-2359 in MYC-driven solid tumors as well as future development plans for MRT-2359 and MRT-6160, its VAV1-directed MGD for autoimmune diseases.
"2023 was an exciting and highlight-filled year for Monte Rosa Therapeutics, including encouraging interim Phase 1/2 MRT-2359 clinical results, advancement of our VAV1-targeted MGD into IND enabling studies, and initiation of a strategic collaboration with Roche," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "Building on last year's successes, this year we look forward to announcing the RP2D for our MRT-2359 program and initiating multiple Phase 2 expansion cohorts in tumors characterized by high L- and N-MYC expression, with the potential to consider indication expansion into c-MYC-driven tumor types such as ER+ breast cancer and castration-resistant prostate cancer. Our highly selective VAV1-directed MGD MRT-6160 is anticipated to enter a Phase 1 healthy volunteer study this year with the aim to move efficiently into early proof-of-concept studies in patients across multiple autoimmune indications. Lastly, we also expect to nominate additional development candidates in 2024 for programs in both oncology and inflammation/immunology. Our strong balance sheet and cash runway into 1H 2026 positions us to advance our programs through important clinical milestones."
Recap of 2023 Achievements
- Presented interim data from the Phase 1/2 clinical trial of MRT-2359 demonstrating tumor reductions in patients with biomarker-positive cancers and favorable pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles.
- Announced development candidate MRT-6160, a VAV1-directed MGD, for the treatment of autoimmune diseases, and presented preclinical data demonstrating that MRT-6160 attenuates autoimmune disease progression.
- Entered into a strategic collaboration and licensing agreement with Roche to discover and develop novel molecular glue degraders targeting cancer and neurological diseases, with a $50 million upfront payment and eligibility to receive future preclinical, clinical, commercial and sales milestone payments exceeding $2 billion, as well as tiered royalties.
Corporate Updates and Key Anticipated Milestones
- Monte Rosa announced today that it has received U.S. Food & Drug Administration Fast Track Designation for MRT-2359 for the treatment of patients with previously treated, metastatic small cell lung cancer (SCLC) with L-MYC or N-MYC expression.
- Monte Rosa expects to announce the RP2D for the MRT-2359 Phase 1/2 clinical trial in MYC-driven solid tumors in ...