Momotaro-Gene: Phase 2 Clinical Trial of MTG201

Momotaro-Gene is a clinical-stage biotherapeutics company that develops novel gene therapies for treating cancer. Today, it announced that it dosed the first patient who was in a Phase 2 clinical trial by combining MTG201, which is the lead therapeutic candidate of the company, with the PD-1 inhibitor nivolumab (Opdivo®) in patients who have relapsed malignant pleural mesothelioma. This combination has illustrated an anti-tumor effect which is robust synergistic in a preclinical model of malignant mesothelioma.

MTG201 is basically a novel investigational gene therapy that has unique dual mechanisms of action and has the capability of addressing a variety of cancers. The drug candidate actually leverages the proprietary adenoviral vector technology platform of the company for delivering the Reduced Expression in Immortalized Cells/Dickkopf-3 gene (REIC/Dkk-3 gene) into cancer cells, where the gene’s expression is down-regulated. The subsequent increase in REIC/Dkk-3 gene expression in the cancer cells activates the death of immunogenic cells selectively in cancer cells. Simultaneously, the elevated expression of REIC/Dkk-3 gene in normal cell components that are in tumor tissue, supports anti-tumor immunity by the activation of dendritic cells and natural killer (NK) cells in the meantime suppressing immune-suppressive regulatory T cells (Tregs) and myeloid-derived suppressor cells (MDSC). On the basis of these novel dual mechanisms, it is believed that MTG201 is well-positioned for working synergistically with the checkpoint inhibitors like nivolumab.

The Phase 2 trial (NCT04013334) is being held at the Baylor College of Medicine in Houston, Texas. It is a single-arm, open-label study that is designed for assessing the efficacy, tolerability, and safety of intratumoral administration of MTG201, in combination with nivolumab. The trial tends to enroll up to 12 patients with malignant mesothelioma with failed front-line systemic platin-based chemotherapy. The most important objective of the study is the assessment of the efficacy of treatment combined with the primary endpoint being an objective response rate (ORR). Secondary efficacy endpoints are to include stabilization of disease, progression-free survival, duration of response, and overall survival. Investigators will also be evaluating exploratory biomarkers of activity, traditional safety measures and the immunogenicity of MTG201.