BMS, Ono, Kyowa Hakko Kirin Form Immunotherapy Pact

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

Opdivo is being studied across multiple tumor types in more than 50 trials, as a monotherapy or in combination with other therapies, in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma, and non-Hodgkin lymphoma (NHL). In 2011, through a collaboration agreement with Ono, Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea, and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies, as single agents and combination regimens, for patients with cancer in Japan, South Korea, and Taiwan.

In 2012, the US Food and Drug Administration (FDA) granted fast track designation for Opdivo in NSCLC, melanoma, and RCC. In April 2014, Bristol-Myers Squibb initiated a rolling submission with the FDA for Opdivo in third-line pretreated squamous cell NSCLC and expects to complete the submission by year-end. The FDA granted Opdivo Breakthrough Therapy Designation in May 2014 for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. On July 4, 2014, Ono Pharmaceutical announced that Opdivo received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma and launched the drug on September 2, making Opdivo the first PD-1 immune checkpoint inhibitor approved and launched anywhere in the world. On September 26, 2014, Bristol-Myers Squibb announced that the FDA accepted for priority review the biologics license application for previously treated advanced melanoma, and the Prescription Drug User Fee Act goal date for a decision is March 30, 2015. The FDA also granted Opdivo Breakthrough Therapy status for this indication. In the EU, the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for Opdivo in advanced melanoma. The application has also been granted accelerated assessment by the EMA's Committee for Medicinal Products for Human Use. The EMA also validated for review the MAA for Opdivo in NSCLC.

Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor type 4 (CCR4). Engineered by Kyowa Hakko Kirin’s Potelligent technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity. Mogamulizumab was launched in Japan in May 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL. The drug was approved for indication expansion and was granted marketing authorization in Japan for the treatment of patients with relapsed or refractory CCR4-positive, peripheral PTCL, and CTCL in March 2014. Clinical trials with mogamulizumab in ATL, PTCL, and CTCL are ongoing in the US, EU, and other countries.

Source: Bristol-Myers Squibb

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