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ONO PHARMACEUTICAL : Fully Human Anti-PD-1 Antibody "ONO-4538/BMS-936558" Results from Phase 1 Study in Cancer Patients Published in New England Journal of Medicine (NEJM) and Presented at Annual Meeting of the American Society of Clinical Oncology (ASCO) (94.2KB)

06/03/2012 | 10:15pm US/Eastern
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June 4th, 2012

ONO PHARMACEUTICAL CO., LTD. Corporate Communications Phone: +81-6-6263-5670 Fully Human Anti-PD-1 Antibody "ONO-4538/BMS-936558" Results from Phase 1 Study in Cancer Patients Published in New England Journal of Medicine (NEJM) and Presented at Annual Meeting of the American Society of Clinical Oncology (ASCO)

Bristol-Myers Squibb Company (hereinafter referred to as "BMS") announced the results from Phase 1 study in patients with non-small-cell lung cancer (NSCLC), metastatic melanoma and renal cell carcinoma (RCC) to be published in New England Journal of Medicine (NEJM) and presented at 48th

Annual Meeting of the American Society of Clinical Oncology (ASCO), on June 2nd (US time).

ONO-4538/BMS-936558, a fully human anti-PD-1 antibody, is an investigational cancer immunotherapy generated under a research collaboration entered into in May 2005 between Ono Pharmaceutical Co., Ltd. (hereinafter referred to as "Ono") and Medarex, Inc. When Medarex, Inc. was acquired by BMS in

2009, it also granted BMS its rights to develop and commercialize the anti-PD-1 antibody in North America. Through the collaboration agreement entered into in September 2011 between Ono and BMS, Ono granted BMS exclusive rights to develop and commercialize ONO-4538/BMS-936558 in the rest of the world, except in Japan, Korea and Taiwan where Ono has retained all rights to develop and commercialize the compound.

BMS is conducting a Phase 2 study in RCC in North America and Europe, and plans to initiate registrational studies for anti-PD-1 this year in NSCLC and RCC, and late 2012, early 2013 for metastatic melanoma. On the other hand, Ono is conducting a Phase 2 study in metastatic melanoma in Japan, and plans to initiate clinical studies in RCC and NSCLC, taking account of the development status in United States and Europe.

Attached from the following page is the press release made by BMS for your information.

Investigational Anti-PD-1 Immunotherapy BMS-936558 Showed Clinical Activity in Phase 1

Trial of Patients with Previously-Treated Non-Small-Cell Lung Cancer, Metastatic Melanoma and Renal Cell Cancer

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