Saitama Medical University has been granted a patent (Japan Patent No. 7781419) for its patent application relating to our core technology, entitled “Immunological biomarkers for predicting the clinical efficacy of cancer immunotherapy.”

The patent granted in Japan is the result of collaborative research with Professor Hiroshi Kagamu of Saitama Medical University and relates to a cell therapy agent containing CD62Llow CD4+ T cells administered in combination with an immune checkpoint inhibitor such as a PD-1 inhibitor. Our company has received an exclusive ordinary license from Saitama Medical University for this patent.

Immune checkpoint inhibitors such as Opdivo® and Keytruda® have demonstrated breakthrough therapeutic effects in many types of cancer. However, more than a half of the patients do not respond to those pharmaceuticals and some of them even show early disease exacerbation after starting treatment. Therefore, we are working hard to commercialize our methods of predicting the outcome of treatment with immune checkpoint inhibitors of PD-1 or PD-L1 inhibitors by measuring the number of specific immune cells of CD62Llow CD4 T cells and CCR4- CCR6+ CD4 T cells in the peripheral blood of cancer patients.

In addition to business of developing biomarkers for predicting the outcome, we will develop how to treat patients who do not respond to immune checkpoint inhibitors. One of the solutions is a cell therapy agent containing CD62Llow CD4+ T cells, which is the invention covered by the newly granted patent.

Administration of our cell therapy agent in combination with an immune checkpoint inhibitor may be successful even in patients who are shown to have possibilities not to respond to immune checkpoint inhibitors by our prediction method. In fact, in tumor model mouse experiments, compared to the group administered with anti-PD-1 antibody alone, the survival rate of the mice administered with a combination of anti-PD-1 antibody and our cell therapy agent was improved. With this patent granted, we aim to commercialize the companion diagnostic business as well as to conduct research and development of cell therapy agents.