2026.03.12
Phase I Clinical Trial Initiated for an Innovative Therapy for Autoimmune Diseases
A Major Step Toward the Clinical Application of Research Developed at FBRI
- Pressrelease
For more detail information
The Institute of Biomedical Research and Innovation (IBRI), which is the institute of Foundation for Biomedical Research and Innovation at Kobe (FBRI) and has four research groups, carries out fundamental research in the research areas of immunotherapy, brain and neurodegenerative disease and infectious disease toward overcoming diseases confronting many people. FBRI advances practical application of innovative therapeutics by promoting joint activities with industry partners.
Today FBRI announces that the Phase I clinical trial of “ME3241," an anti-PD-1 agonist antibody, a drug candidate discovered through drug discovery research targeting autoimmune diseases, has been initiated in Australia. This milestone represents the outcome of collaborative research conducted since 2016 by the Department of Immunology (Professor Akio Ohta) at IBRI and Meiji Seika Pharma Co., Ltd. It is our honor to announce that FBRI marks a significant step toward clinical application.
Press Release
Meiji Seika Pharma initiates Phase I clinical trial in Australia evaluating
ME3241, an anti-PD-1 agonist antibody discovered through collaborative research with FBRI
Message from Tasuku Honjo, Program Director, Honorary President, FBRI
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The initiation of the Phase I clinical trial of an autoimmune disease therapy by a PD-1 agonist antibody is highly significant, as our finding marks a major milestone in taking a step toward potential therapeutic application for human disease.
This therapeutic approach, which is completely opposite of the widely used cancer therapy employing a PD-1 antagonist antibody, originated from basic research initiated shortly after my appointment as director. After achieving robust results in animal models, we have now reached this clinical stage.
Should safety be confirmed in Phase I, there is strong expectation that the program will progress to Phase II to evaluate efficacy, and subsequently to Phase III with the aim of practical implementation. I am truly delighted by this advancement toward the practical realization of the vision of Kobe Biomedical Innovation Cluster.
＊＊＊＊＊＊＊＊＊＊＊＊＊＊＊＊＊
Institute of Biomedical Research and Innovation Website
Today FBRI announces that the Phase I clinical trial of “ME3241," an anti-PD-1 agonist antibody, a drug candidate discovered through drug discovery research targeting autoimmune diseases, has been initiated in Australia. This milestone represents the outcome of collaborative research conducted since 2016 by the Department of Immunology (Professor Akio Ohta) at IBRI and Meiji Seika Pharma Co., Ltd. It is our honor to announce that FBRI marks a significant step toward clinical application.
Foundation for Biomedical Research and Innovation at Kobe
President Shu Narumiya
Press Release
Meiji Seika Pharma initiates Phase I clinical trial in Australia evaluating
ME3241, an anti-PD-1 agonist antibody discovered through collaborative research with FBRI
Message from Tasuku Honjo, Program Director, Honorary President, FBRI
＊＊＊＊＊＊＊＊＊＊＊＊＊＊＊＊＊
The initiation of the Phase I clinical trial of an autoimmune disease therapy by a PD-1 agonist antibody is highly significant, as our finding marks a major milestone in taking a step toward potential therapeutic application for human disease.
This therapeutic approach, which is completely opposite of the widely used cancer therapy employing a PD-1 antagonist antibody, originated from basic research initiated shortly after my appointment as director. After achieving robust results in animal models, we have now reached this clinical stage.
Should safety be confirmed in Phase I, there is strong expectation that the program will progress to Phase II to evaluate efficacy, and subsequently to Phase III with the aim of practical implementation. I am truly delighted by this advancement toward the practical realization of the vision of Kobe Biomedical Innovation Cluster.
＊＊＊＊＊＊＊＊＊＊＊＊＊＊＊＊＊
Institute of Biomedical Research and Innovation Website
Contact Us
Foundation for Biomedical Research and Innovation at Kobe
kbic-pr@fbri-kobe.org
Date
2026年03月12日
Editor
神戸医療産業都市推進機構