March 10, 2015

Announcement of the commencement of T cell receptor (TCR) analysis business
OncoTherapy

Science,Inc.

(President&CEO:Masaharu

Mori;hereinafter,“OncoTherapy”) announces that OncoTherapy has decided at the Board meeting tointroduce a T cell receptors (TCR) method using the next-generation sequencer (*1) thatwas developed by Professor Yusuke Nakamura’s laboratory at Department of Medicine,the University of Chicago,

for applying it to OncoTherapy’s vaccine development

program. We will also start a TCR analysis services business to customers including
pharmaceutical companies and academic institutions.
Cancer immunotherapy has been developed as the fourth cancer therapy in addition tosurgery, radiotherapy, and chemotherapy. For example, immune checkpoint antibody
therapies (*2) developed by domestic and foreign pharmaceutical companies wereapproved in the United States and Japan. Furthermore, a cancer vaccine therapy
against prostate cancer developed by a U.S. pharmaceutical company was approved intheUnitedStates.

However,

detailed

molecular

mechanismsofactionof

immunotherapy, including how cancer cells are attacked and eliminated, have not been
fully clarified yet. In addition, since these treatments are extremely expensive, it isimportant to select patients who are likely to respond well to

the treatment or tomonitor immune responses in patients for the decision making process

to or not tocontinue the therapy.
The high-throughput TCR analysis method that OncoTherapy introduces can monitorchanges in T cells in blood, cancer tissues, ascites and pleural effusion, and rapidly
provide the information of TCRs from a few to more than ten million T cells. Themethod is also applicable to B cell receptors (BCR) analysis (*1) and to various disease
conditions including autoimmune diseases, drug hypersensitivity, food allergies andinfections.
OncoTherapy, in collaboration with the University of Chicago, will develop world’s mostadvanced TCR analysis techniques to apply them to selecting patients for vaccine
therapies and monitoring the course of treatment. OncoTherapy will thus conduct theresearch and development of the TCR analysis and its commercialization to contributeto medicine.

(*1) Methods for studying characteristics of T cells (or B cells) by determining DNA
sequences of T cell receptors (or B cell receptors) that recognize antigens.
(*2) Therapies that activate T cells to attack cancer cells by inhibiting the functions ofimmune checkpoint molecules that play roles of suppressing immune responses toprotect cancer cells.
References(1) H. Fang, R. Yamaguchi, X. Liu, Y. Daigo, P.Y. Yew, C. Tanikawa, K. Matsuda, S. Imoto, S. Miyano,and Y. Nakamura: Quantitative T Cell Repertoire Analysis by Deep cDNA Sequencing of T Cell Receptor
 and  Chains using Next-Generation Sequencing (NGS). OncoImmunology, :DOI:
10.4161/21624011.2014.968467, 2014
(2) X. Liu, G. Venkataraman, J. Lin, K. Kiyotani, S. Smith, M. Montoya, Y. Nakamura, and J. Kline:
Highly clonal T cell receptor repertoire among regulatory T cells in follicular lymphoma tissues –correlation with the CD8+ T cell receptor repertoire. OncoImmunology, DOI:10.1080/2162402X.2014.
1002728, 2015