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Ono Pharmaceutical, BMS and Kyowa Hakko Kirin Announce Collaboration

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Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb Company and Kyowa Hakko Kirin Co., Ltd. have announced the companies have entered into a clinical trial collaboration agreement to conduct a Phase 1 combination study with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, and mogamulizumab, an anti-CCR4 antibody.

The study, which will be conducted in Japan, will focus on evaluating the safety, tolerability and anti-tumor activity of combining Opdivo and mogamulizumab as a potential treatment option for patients with advanced or metastatic solid tumors.

Opdivo, launched in Japan in September 2014 for the treatment of patients with unresectable melanoma, is being developed in multiple tumor types in more than 50 clinical trials worldwide. Mogamulizumab was launched in Japan in May 2012 for the treatment of relapsed or refractory CCR4-positive Adult T-cell Leukemia-Lymphoma (ATL), and granted the indication expansion in March 2014 for relapsed or refractory CCR4-positive Peripheral T-Cell Lymphoma (PTCL) and Cutaneous T-Cell Lymphoma (CTCL). Clinical trials with mogamulizumab in ATL, PTCL, and CTCL are ongoing in the US, EU and other countries.

Opdivo and mogamulizumab are part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Opdivo binds to the checkpoint receptor PD-1 expressed on activated T-cells, blocking this pathway and enabling the immune system to attack tumors, while mogamulizumab can suppress some of the immune cells that shield the tumor from the immune system. Pre-clinical evidence for each therapy suggests the combination of Opdivo and mogamulizumab may lead to an enhanced anti-tumor immune response compared to either agent alone.

“Studying combination regimens of immunotherapies offers the opportunity to explore the potential of enhanced efficacy compared to current standards of care in treating cancer,” said Hiroshi Awata, Member of the Board of Directors, Vice President Executive Officer/ Executive Director, Clinical Development & Clinical Development Planning, ONO. “We are delighted to be able to pursue the possibility of immunotherapies through this collaboration with Kyowa Hakko Kirin. We believe that there is a strong rationale to explore the combination of Opdivo and mogamulizumab with the goal of identifying a new treatment option for these cancer patients.”

“Our collaboration with Kyowa Hakko Kirin further complements the broad clinical development program for Opdivo, will advance our understanding of the combination of Opdivo and mogamulizumab, and is an example of our commitment to develop combination immuno-oncology regimens for patients with metastatic cancer,” stated Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb.

“It is exciting for us to build a partnership with ONO and BMS in immuno-oncology,” said Yoichi Sato, Managing Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin. “The planned combination study will help determine whether the combination of these two immunotherapies can deliver better outcomes in patients with advanced cancers.”