Biotherapeutics company Momotaro-Gene has announced the beginning of a Phase 2 clinical trial on their innovative treatment for malignant mesothelioma. The study will analyze the efficacy of the company’s novel gene therapy called MTG201 combined with the PD-1 inhibitor nivolumab (Opdivo) on patients whose cancer has returned.
Treatment being tested on patients who have relapsed
The study’s first patient received the combination after a relapse of their malignant pleural mesothelioma after having already failed front-line platinum-based chemotherapy. The drug’s manufacturer plans to test the protocol on a total of 12 patients with similarly limited treatment options. Laboratory testing has already shown that the combination of MTG201 and the PD-1 inhibitor stop the growth of mesothelioma cells.
The mechanism that makes MTG201 effective in the treatment of malignant mesothelioma and other cancers works in two ways. It first delivers the REIC/Dkk-3 gene into cancer cells via the company’s proprietary adenoidal vector technology platform, raising the gene expression in cells in which it has been reduced and triggering cell death, while at the same time increasing the gene’s expression in healthy cells within the tumor. This activates natural killer cells within the body’s immune system. The two actions together work particularly well when combined with the checkpoint inhibitor nivolumab.
Phase 2 study follows successful safety testing
Baylor College of Medicine in Houston, Texas has been instrumental in many innovations and studies into malignant mesothelioma, and is the site of the Phase 2 trial. After having established MTG201’s safety, this second phase will assess the effectiveness, safety and tolerability of the combination of the drug with nivolumab. Patients will be followed to determine their response rate, disease stabilization, period of progression-free survival, duration of response and overall survival.
Speaking of their hopes for the mesothelioma study, Momotaro-Gene Inc.’s chief executive officer Hitoshi Shiomi said, “The initiation of this Phase 2 clinical trial represents a key milestone in the ongoing development program for MTG201 as it will allow us to build upon the promising results achieved in our two Phase 1 trials of the treatment. Importantly, this study will provide us the very first human data highlighting the therapeutic potential of combining MTG201 with a checkpoint inhibitor, a combination which we believe has significant promise based on preclinical studies. We look forward to working with our collaborators at the Baylor College of Medicine on this important study and continuing to advance MTG201 as a potential treatment for patients suffering with a range of cancers.”
Bryan Burt, M.D., associate professor of surgery at Baylor College of Medicine and the principal investigator for the study said, “Mesothelioma represents an aggressive cancer for which new treatment options are desperately needed. This is especially true for relapsed forms of the disease, for which there are currently no approved therapies. Based on preclinical research that my team has conducted on the combination of MTG201 and an anti-PD-1 checkpoint inhibitor, we believe that the synergistic combination of these two therapies may hold promise in this patient population. We are pleased to have the opportunity to conduct this exciting study at the Baylor College of Medicine and look forward to the results of the trial.”
For more information on this and other clinical trials on malignant mesothelioma treatments, contact the Patient Advocates at Mesothelioma.net at 1-800-692-8608.