The examiner’s assessment in Japan has been issued to the patent application for “Immunological biomarker for predicting clinical effect of cancer immunotherapy” filed by Saitama Medical University.

ImmunniT Research Inc. would like to announce that notice of allowance for the patent application entitled, “Immunological biomarker for predicting clinical outcome of cancer immunotherapy”, filed by Saitama Medical University has been issued. This company has obtained the exclusive normal license of this patent application from Saitama Medical University, which is related to our core technology.

Every possible effort shall be made so that patent rights would be granted to all the foreign patent applications as well as divisional applications of the Japanese patent application.

This patent application has been derived from the results of research by Professor Hiroshi Kagamu at Saitama Medical University, the Scientific Advisor to ImmuniT Research Inc. He invented a method for predicting the outcome of treatment with an immune checkpoint inhibitor of a PD-1 or PD-L1 inhibitor by counting the number of specific immune cells in the blood of cancer patients. This patent application also covers a reagent kit using this method for predicting the efficacy of immune checkpoint inhibitors and immune checkpoint inhibitors to be administered with patients who have been predicted by this method not to be ineffective of an immune checkpoint inhibitor.

ImmuniT Research Inc. recognizes this patent application as one of the fundamental and the most important patents relating to our business. We are confident that decision to grant this patent enables us to secure the exclusivity of the companion diagnostics business for immune checkpoint inhibitors in Japan. The companion diagnostics which will be developed with this method is characterized by its high sensitivity and specificity, and low invasiveness due to the use of peripheral blood.

Immune checkpoint inhibitors such as Opdivo^® and Keytruda^® have shown epoch-making therapeutic effects on many types of cancer. It has been proven that long-term control of cancer for several years can be achieved for effective cases, and that the efficacy of those inhibitors continues for some patients even after the treatment has been discontinued. On the other hand, about a half of the ineffective cases are known to show exacerbation of the disease early after the beginning of this treatment. It is considered that since these medications are expensive, this treatment may have a negative impact on the healthcare economy. Therefore, it is urgently required to develop a technology that can predict the outcome of the treatment before or early after administration with those inhibitors and help selection of an appropriate immune checkpoint inhibitor for appropriate cases.

ImmunniT Research’s joint effort with Saitama Medical University at our laboratory in the Research Park at the University under a collaborative research agreement between the two would make it possible to commercialize the patent application so that we would be a part of the team who contributes to rationalize the national healthcare budget and healthcare environment as a whole.

There are various types of immune checkpoint inhibitors, and most of those on the current market are PD-1 or PD-L1 inhibitors.