• The Phase 2 study will register approx. twelve patients diagnosed with malignant mesothelioma that have failed systemic platin-based front-line chemotherapy.
   
• The key objective of the trial is to evaluate efficacy of MTG201- Nivolumab treatment combination with objective response rate being the primary endpoint.

Momotaro-Gene, a Okayama, Japan based clinical-stage biotherapeutics firm developing new gene therapies for cancer treatment, reportedly announced that it has dosed the first patient in Phase 2 clinical trial that combines MTG201, the lead therapeutic candidate of company, with nivolumab (Opdivo®), PD-1 inhibitor, in patients with malignant pleural mesothelioma that has relapsed. 

The treatment combination of the company’s MTG201 with PD-1 inhibitor has showcased a strong synergistic anti-tumor effect on malignant mesothelioma’s preclinical model.

The Phase 2 clinical trial would be enrolling approx. twelve patients diagnosed with malignant mesothelioma that have failed systemic platin-based front-line chemotherapy. The key objective of the trial is to evaluate efficacy of MTG201- Nivolumab treatment combination with objective response rate (ORR) being the initial endpoint.

Chief Executive Officer of Momotaro-Gene Inc., Hitoshi Shiomi stated that the Phase 2 clinical trial’s initiation demonstrates a vital milestone in the presently active MTG201 development program as it would enable the company to further build upon the positive results that were achieved in the company’s two Phase 1 clinical trials that assessed the treatment. 

Hitoshi also stated that this trial would provide the company with the first human data emphasizing the overall therapeutic potential of integrating MTG201 with a single checkpoint inhibitor, an therapeutic combination the company believes has significant potential based upon preclinical studies.

Hitoshi further added that the company looks forward to work with its collaborators at Baylor College of Medicine for this study and to continue MTG201 advancement as potential treatment option for individuals suffering from an array of cancers.

The Phase 2 clinical trial, being conducted in the Houston, Texas based Baylor College of Medicine, comes after two Phase 1 MTG201 clinical trials showcased encouraging tolerability and safety in patients.

Source credit: https://markets.businessinsider.com/news/stocks/momotaro-gene-announces-first-patient-dosed-in-phase-2-clinical-trial-of-mtg201-in-combination-with-nivolumab-in-patients-with-relapsed-malignant-pleural-mesothelioma-1028515931