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FDA Clears MT-125 for First Human Trials in Treatment-Resistant Glioblastoma

It has been licensed to Myosin Therapeutics, which plans to begin human studies within the year.

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Overview

  • The FDA approved MT-125 to enter first-in-human trials after mouse studies demonstrated its ability to overcome glioblastoma resistance to radiation and chemotherapy.
  • MT-125 targets non-muscle myosin II to sensitize previously resistant tumor cells to radiation and kinase inhibitors while blocking their invasive behavior.
  • Mechanistic research showed the inhibitor disrupts mitochondrial fission, causing reactive oxygen species buildup, DNA damage and ferroptosis in glioblastoma cells.
  • In preclinical mouse models, MT-125 exhibited strong brain penetrance, minimal toxicity and durable tumor remissions when combined with kinase inhibitors such as sunitinib.
  • Myosin Therapeutics licensed MT-125 for imminent clinical development and is also advancing a related compound, MT-110, toward trials for methamphetamine use disorder.