February 15, 2018
Mie University
BrightPath Biotherapeutics Co., Ltd.

Mie University and BrightPath Launch New Program for
Neoantigen-based Personalized Cancer Immunotherapy

Tokyo, February 15, 2018 – Mie University and BrightPath Biotherapeutics Co., Ltd.
(“BrightPath”) have decided to launch a “Personalized Cancer Immunotherapy” Program(the “Program”) as an academia-industry collaboration. The Program is aimed atdeveloping fully-personalized cancer immunotherapy that targets neoantigens. Under theframework of the Program, Mie University and BrightPath will commence collaborative
research to establish a technology platform for detecting and identifying neoantigens andthen developing appropriate modalities targeting them.*1, *2
Remarkable clinical outcomes using immune checkpoint inhibitors have recently opened a
new paradigm in cancer treatment and have demonstrated two important aspects. First, Tcells, one of the various types of immune cells in the patient’s body, play a primary role inattacking cancer cells and demonstrate strong functionality to efficiently kill them. Second,
neoantigens derived from gene mutations in the patient’s tumor serve as landmarks for Tcells to lock onto cancer cells. State-of-the-art technology in genome sequencing andanalysis technologies spurred by the advent of next-generation DNA sequencers is making
it possible to analyze cancer-specific genetic mutations and neoantigens that arecompletely unique to each patient.
The Program is intended to utilize such unique neoantigens from each patient as a tailored
cancer immunotherapy. In this way, the conventional “one-size-fits-all” drugs that are
currently used to treat millions of patients will evolve into a next-generation, fully“personalized” therapy that uses the patient’s own T-cells to recognize mutations that areunique to his/her cancer cells and that can adapt to individuality and variety.
Under the Program, we will establish methods for precise detection of gene mutations frompatient tumor tissue and identification of epitopes (neoantigens) that strongly induce T-cell
immune responses. Based on the technology platform for neoantigen identification, we willdevelop optimum forms of modalities for a new generation of cancer immunotherapies.
The Program is led by Dr. Hiroshi Shiku at Mie University Graduate School of Medicine. For
many years, he has been engaged in the research and development of cancer
immunotherapy, including cancer peptide vaccines and antigen receptor transduced T-celltherapy (TCR-T), ranging from exploratory through translational research to first-in-humanclinical trials. With regard to fully-personalized cancer immunotherapy, which is the subjectof the Program, Dr. Shiku has already been advancing exploratory research for over fiveyears. In the last year of a four-year research program, a project organized by Ministry ofHealth, Labour and Welfare was implemented to formulate the series, “Guidance forClinical Development of Cancer Immunotherapy,” with the participation of more than 50
academician cancer immunotherapy researchers and government officials in Japan. Thisguidance covers the entire field of the cancer immunotherapy and development process,from non-clinical to clinical trials. In this project, Dr. Shiku served as a project leader andplayed a key role in organizing and compiling the guidance. As the Program leader, Dr.
Shiku will fully leverage his vast knowledge, technical expertise and experimental systems
in pursuit of the Project’s successful conclusion.
Mie University and BrightPath are set to create new immunotherapies to enable1personalized cancer care to be developed in Japan and disseminated around the world.

*1. A neoantigen is defined as a tumor antigen generated from gene mutations present incancer cells. The human immune system recognizes antigens, which induce immuneresponses. While the immune system does not strongly respond to the body’s normal“self” antigens, a strong immune response is generated against “non-self” neoantigens
since they are present only on tumor cells.
*2. Modality: A category of physical therapeutic agents such as small-moleculecompounds, peptide vaccines, antibody drugs, nucleic acid therapy, and cell therapy

BrightPath
BrightPath is a clinical stage biopharmaceutical company focused on the development ofnovel cancer immunotherapies to transform cancer treatment for progressive or refractory
cancers that cannot be treated using conventional standard therapies. In addition to thecancer peptide vaccines currently under clinical trials in Japan and the United States,
BrightPath is actively involved in developing cell therapies, immunomodulatory antibodies
and new drugs targeted toward cancer-specific neoantigens.

Contacts
Mie University[About Collaborative Research]
Department of Immuno-gene Therapy
Center for Comprehensive Cancer Immunotherapy
Tel: +81-59-231-5187
http://www.shikuken.jp/en/[About Personalized Cancer Immunotherapy Program]Mie University Academic Affairs and Information Department Social Cooperation
Management OfficeTel: +81-59-231-9006
http://www.opri.mie-u.ac.jp/cooperation/collaboration/riyouhouhou.pdf
BrightPath Biotherapeutics Co., Ltd.
Business Administration
Tel: +81-3-5840-7697
https://www.brightpathbio.com/english/index.html

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