Osaka University
Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
August 21, 2018

Osaka University and Otsuka Pharmaceutical to Enter into an Executive Licensing
Agreement on Novel "CAR-T Cell Therapy" for Multiple Myeloma

Osaka University and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that Osaka University and Otsuka entered into an exclusive, worldwide license of patents associated with MMG49 CAR-T cell therapy. MMG49 CAR-T cell therapy specifically targets the active conformer of integrin β7 identified in Osaka University.

MMG49 CAR-T cell based therapy is a novel treatment of multiple myeloma, which has been developed by a research group comprising Associate Professor Naoki Hosen, Department of Cancer Stem Cell Biology, Osaka University Graduate School of Medicine; Professor Atsushi Kumanogoh, Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine; Professor Haruo Sugiyama, a specially appointed professor at Osaka University Graduate School of Medicine who hosts a collaborative seminar on cancer immunology research co-sponsored by Otsuka.

In November last year, Osaka University announced that CAR-T cells incorporating MMG49 demonstrated a remarkable anti-tumor effect against multiple myeloma tumor cells in non-clinical studies. (Press Release, Osaka University, November 2017)

With this agreement consummated, Otsuka will make an up-front payment to Osaka University, as well as development milestone payments and sales royalties. Osaka University and Otsuka will collaborate in basic research on all indications including its diagnostic applications. Otsuka will exclusively pursue development, manufacturing and commercialization.

Dr. Toshiki Sudo, board member for Research at Otsuka Pharmaceutical mentioned, "We are continuing to challenge creating innovative products by our original ideas and technologies to contribute to the health of people worldwide. We hope this agreement will lead to the development of new gene therapies for multiple myeloma. We are going to move forward the research & development in the biologics field including gene therapy and cell therapy for unmet medical needs."

Associate Professor Naoki Hosen, Graduate School of Medicine, Osaka University (Department of Cancer Stem Cell Biology) gave, "Although the recent progress for the treatments of multiple myeloma is remarkable, it is still extremely difficult to cure. Therefore, the development of new therapeutic drugs is required. In non-clinical studies, MMG49 CAR-T cell therapy has been shown to be a promising novel immunotherapy for multiple myeloma. I'm convinced that the development can be promoted efficiently by partnering with Otsuka Pharmaceutical which develops hematology cancer drugs actively and globally."

MMG49

The research group in Osaka University focused on integrin β7, which is necessary for cell-cell adhesion, on the cell surface of cancerous myeloma, and then identified antibody MMG49 which bound to the activated conformer of integrin β7. It was shown that CAR-T cells with the antigen recognition site of MMG49 eliminate only cancerous myeloma cells specially without damaging normal cells in non-clinical studies. For details, please refer to the following Osaka University Press Release (November 2017).

http://www.med.osaka-u.ac.jp/eng/activities/results/2017year/17-11-27

Multiple myeloma

Multiple myeloma is a hematology cancer in which plasma cells producing antibodies in the bone marrow become malignant, and then randomly increased and accumulated. In recent years, treatment options have increased and the survival period has been prolonged. However, this is still a difficult disease to treat.

CAR-T cell therapy

CAR- (chimeric antigen receptor) T cell therapy is a type of treatment in which a patient's T cells (a type of white blood cell with key role in immune defenses) are altered so they will attack cancer cells. A gene for a special receptor that binds to a certain protein on the patient's cancer cells is introduced to the T cells. The special receptor is called a chimeric antigen receptor.