MT-125 / Myosin Therap - LARVOL DELTA

NOVA-GBM: A Phase 1/2 Study of Safety and Tolerability of MT-125 With Chemoradiation in Patients With Newly Diagnosed MGMT Methylated Glioblastoma (clinicaltrials.gov) - P1/2 | N=36 | Not yet recruiting | Sponsor: Myosin Therapeutics Inc.

First-in-human • Monotherapy • New P1/2 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

Myosin Therapeutics Initiates Phase 1/2 STAR-GBM Trial of MT-125 Targeting Non-muscle Myosin II in Newly Diagnosed Glioblastoma (PRNewswire) - "The STAR-GBM trial is supported by the National Cancer Institute and by a syndicate of life sciences investors and philanthropic organizations."

Trial status • Glioblastoma

STAR-GBM: A Phase 1/2 Study of the Safety and Tolerability of MT-125 in GBM Patients (clinicaltrials.gov) - P1/2 | N=36 | Recruiting | Sponsor: Myosin Therapeutics Inc. | Not yet recruiting ➔ Recruiting | Phase classification: P1 ➔ P1/2 | Trial completion date: Jun 2027 ➔ Feb 2032 | Initiation date: Nov 2025 ➔ Apr 2026

Enrollment open • First-in-human • Monotherapy • Phase classification • Trial completion date • Trial initiation date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

Myosin Therapeutics Receives FDA Fast Track Designation for MT-125 in Glioblastoma (PRNewswire) - "A Phase 1/2 trial evaluating safety, pharmacokinetics, and preliminary activity is cleared to proceed (ClinicalTrials.gov: NCT07185880)."

Fast track • Trial status • Glioblastoma

STAR-GBM: A Phase 1 Study of the Safety and Tolerability of MT-125 in GBM Patients (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Myosin Therapeutics Inc.

Monotherapy • New P1 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Myosin Therapeutics Receives FDA Clearance to Initiate First-in-Human Trial of MT-125 in Glioblastoma (PRNewswire) - "Myosin Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for MT-125. The active IND allows the company to initiate a Phase 1 study to evaluate MT-125 in combination with standard of care radiation in patients with newly diagnosed IDH wild type, MGMT unmethylated glioblastoma.....MT-125 has been granted Orphan Drug Designation by the FDA for the treatment of malignant gliomas, including glioblastoma, recognizing the potential of MT-125 in this rare and devastating disease and providing additional regulatory and financial support for the drug's development."

IND • New P1 trial • Orphan drug • Glioblastoma • Glioma

Myosin Therapeutics Closes Second Seed Round to Advance Clinical Trials for Innovative Cancer and Neuroscience Therapies (PRNewswire) - "Myosin Therapeutics...has closed its second seed funding round, raising over $3 million to supplement significant investment from the National Institutes of Health...The latest funding, combined with NIH support, will allow MT-110 to enter Phase 1 clinical trials....'This funding is pivotal as it will allow us to initiate multiple clinical trials this year, including a Phase 1b trial for MT-125 in glioblastoma patients.'"

Financing • New P1 trial • CNS Disorders • Glioblastoma

MT-125 Inhibits Non-Muscle Myosin IIA and IIB, Synergizes with Oncogenic Kinase Inhibitors, and Prolongs Survival in Glioblastoma (SNO 2024) - "Combining MT-125 with sunitinib, a PDGFR inhibitor, or paxalisib, a combined PI3 Kinase/mTOR inhibitor, in vivo doubles median survival in a highly aggressive murine orthotopic GBM model. Furthermore, combining MT-125 with sunitinib produces tumor free remissions of >100 days--2.5-fold greater than median survival of either drug alone—in approximately 40% of mice. Our results provide a powerful rationale for developing NMII targeting strategies to treat cancer and demonstrate that MT-125 has strong clinical potential for the treatment of GBM."

Brain Cancer • CNS Disorders • CNS Tumor • Glioblastoma • Hematological Disorders • Oncology • Psychiatry • Solid Tumor

[PREPRINT] MT-125 Inhibits Non-Muscle Myosin IIA and IIB, Synergizes with Oncogenic Kinase Inhibitors, and Prolongs Survival in Glioblastoma (bioRxiv) - "Combining MT-125 with sunitinib, a PDGFR inhibitor, or paxalisib, a combined PI3 Kinase/mTOR inhibitor significantly improves survival in orthotopic GBM models over either drug alone, and in the case of sunitinib, markedly prolongs survival in ∼40% of mice. Our results provide a powerful rationale for developing NMII targeting strategies to treat cancer and demonstrate that MT-125 has strong clinical potential for the treatment of GBM."

Preclinical • Preprint • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Myosin Therapeutics Closes Seed Round to Continue Development of Innovative Therapies for Glioblastoma and Stimulant Use Disorder (PRNewswire) - “Myosin Therapeutics Inc…announced today that it supplemented its National Institutes of Health (NIH) funding with a seed funding round to advance the company's lead programs on glioblastoma and stimulant use disorder. Myosin Therapeutics…is developing its lead compound, MT-125, to treat glioblastoma, which is a highly aggressive form of brain cancer with a 95% fatality rate and limited treatment options available. In early models, MT-125 has shown that it can simultaneously arrest cancer cell division and migration, and therefore could be a first-in-class therapy. The Company believes that this funding should allow it to reach IND filing for MT-125.”

Financing • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor