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January 15, 2014

Addition of Japanese Sites for Pivotal Phase 3 Trial of Mogamulizumab (KW-0761) in Patients with Cutaneous T-Cell Lymphoma

Tokyo, Japan, January 15, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced the addition of Japanese sites for an ongoing phase 3 clinical trial in the United States and Europe to evaluate the efficacy and safety of mogamulizumab (generic name / code name: KW-0761) in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL).

Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including CTCL cells. Engineered by Kyowa Hakko Kirin's unique POTELLIGENT® Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC).
Mogamulizumab was approved in Japan in March 2012 for the treatment of patients with relapsed or refractory CCR4-positive Adult T-Cell Leukemia-Lymphoma (ATL).

Kyowa Hakko Kirin is committed to developing treatments for a wide range of diseases with unmet medical needs, including orphan diseases such as CTCL. Kyowa Hakko Kirin strives to contribute to the improvement of patients' quality of life (QOL) through the development of innovative therapeutics.

Outline of the Phase 3 Trial of Mogamulizumab in Patients with CTCL Identifier NCT01728805
Condition Relapsed/refractory CTCL
Trial Design Multi-center, open-label, randomized trial of mogamulizumab or vorinostat
1.0 mg/kg weekly x 4 in cycle 1 then every other week in subsequent cycles until progression in 28-day treatment cycles
400 mg orally daily until progression
Trial Location the United States, Europe and Japan
Primary Objective Progression-free survival

About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a rare, low grade type of non-Hodgkin's lymphoma. CTCL is one of the most common forms of T-cell lymphoma. The two most common types of CTCL are mycosis fungoides (MF) and Sézary syndrome (SS). MF does not look the same in all patients and may present as skin patches, plaques, and tumors. SS in an advanced form of MF and includes the presence of malignant lymphocytes in the blood.

POTELLIGENT® is Kyowa Hakko Kirin's unique technology for the production of antibodies with enhanced ADCC activity. This technique enables production of antibodies with a reduced amount of fucose in their carbohydrate structure. Non-clinical studies have demonstrated that antibodies produced using this technology killed target cells more efficiently than conventional antibodies and exhibited stronger antitumor effects. For more information, please visit

About CC chemokine receptor 4 (CCR4)
CCR4 is one of the chemokine receptors involved in leukocyte migration, selectively expressed in type 2 helper T (Th2) cells and regulatory T (Treg) cells. CCR4 is also shown to be over-expressed in certain hematological malignancies.

About antibody-dependent cellular cytotoxicity (ADCC)
ADCC is an immune reaction of the body, initiated by the binding of an antibody to its antigen on target cells, followed by lysis of the antibody-bound target cells by effector cells such as natural killer cells. ADCC is known to be one of the modes of action of therapeutic antibodies.

About Adult T-cell leukemia-lymphoma (ATL)
ATL is a rare and aggressive form of T-cell non-Hodgkin's lymphoma that is caused by human T-lymphotropic virus-1 infection. This virus selectively infects T-cells. The incidence of ATL is highest in geographic areas where HTLV-1 infection is endemic, including areas of southern Japan, South and Central America, West Africa, the southeastern US, and the Caribbean basin. ATL is a rare disease with no established standard of care.

About Vorinostat
Vorinostat (ZOLINZA®) is a histone deacetylase inhibitor. It was approved by the U.S. Food and Drug Administration on October 6, 2006, and by Japan's Ministry of Health, Labour and Welfare on June 14, 2011 for the treatment of CTCL.


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