Okayama, Japan (GLOBE NEWSWIRE) — Momotaro-Gene, a clinical-stage biotherapeutics company that develops novel gene therapies for cancer treatment, today announced the first patient dosage in a Phase 2 clinical trial combining MTG201, the company’s leading therapeutic candidate, with PD-1 inhibitor nivolumab (Opdivo ®) in patients with relapsed pleural mesothelioma. In a preclinical model of malignant mesothelioma, the mixture of MTG201 and a PD-1 inhibitor proved a strong anti-tumor synergistic impact.
MTG201 is a novel gene therapy with distinctive dual action systems that can address a variety of cancers. The drug candidate leverages the company’s proprietary adenoviral vector technology platform to produce reduced activity in the Immortalized Cells / Dickkopf-3 gene (REIC /Dkk-3 gene) to cancer cells where gene expression has been demonstrated to be significantly down-regulated. The subsequent rise in gene expression of REIC /Dkk-3 in cancer cells selectively causes immunogenic cell death in cancer cells. At the same moment, enhanced REIC /Dkk-3 gene production in ordinary tumor tissue cell components encourages anti-tumor immunity by activating dendritic cells and natural killer (NK) neurons while suppressing intrinsic suppressive maternal T neurons (Tregs) and myeloid-derived suppressor cells (MDSC). It is thought that MTG201 is well placed to operate synergistically with checkpoint inhibitors such as nivolumab based on these novel dual processes.
The Phase 2 trial (NCT04013334), conducted at the Baylor College of Medicine in Houston, Texas, is an open-label, single-arm study designed to evaluate the effectiveness, safety and tolerability of MTG201 intratumoral administration in combination with nivolumab. The trial will register up to twelve malignant mesothelioma patients who have failed systemic front-line platinum-based chemotherapy. The study’s primary objective is to evaluate the effectiveness of the mixture of therapy with objective response rate (ORR) being the main endpoint. Secondary efficacy endpoints will include stability of disease, reaction length, progression-free survival, and general survival. Researchers will also assess traditional safety interventions, activity exploratory biomarkers, and MTG201 immunogenicity.