Date: 2017-01-05
Type of information: Clinical research agreement
Compound: Opdivo® (nivolumab) and Darzalex®(daratumumab)
Company: BMS (USA - NY) Janssen Biotech, a J&J company (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody/immune checkpoint inhibitor. Nivolumab is a fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. Opdivo® is thought to provide benefit by blocking PD-1-mediated negative regulation of lymphocytes, thereby enhancing the ability of the immune system to recognize cancer cells as foreign and eliminate them. This monoclonal antibody has been generated under a research collaboration entered into in May 2005 between Ono and Medarex. When Medarex was acquired by BMS in 2009, it also granted BMS its rights to develop and commercialize the anti-human PD-1 monoclonal 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 Opdivo® in the rest of the world, except in Japan, Korea and Taiwan where Ono has retained all rights to develop and commercialize the compound. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. In August 2012, Genmab granted Janssen Biotech, an exclusive worldwide license to develop, manufacture and commercialize daratumumab. This cytolytic antibody is believed to induce tumor cell death through multiple immune-mediated mechanisms of action and also demonstrates immunomodulatory activities by targeting immuno-suppressive cells in the tumor microenvironment. The combination of these agents may enhance immune-mediated killing of tumors.
Disease: multiple myeloma and solid tumors including non-small cell lung cancer, pancreatic cancer, colorectal cancer, triple negative breast cancer and head and neck cancer
Details: * On January 5, 2017, BMS announced a new clinical research collaboration with Janssen Biotech to evaluate the combination of Opdivo® and Janssen’s CD38-directed cytolytic antibody Darzalex® in Phase 1b/2 clinical studies in multiple myeloma and solid tumors including non-small cell lung cancer, pancreatic cancer, colorectal cancer (CRC), triple negative breast cancer and head and neck cancer. In 2016 an existing Bristol-Myers Squibb Phase I study was expanded to include the combination of Opdivo® and Darzalex® in multiple myeloma; this study is ongoing. Additional studies will start in 2017. This agreement builds off BMS and Janssen’s previous clinical research collaboration announced in July, 2016 to evaluate Opdivo® and Janssen’s Live Attenuated Double–Deleted (LADD) Listeria monocytogenes cancer immunotherapy, expressing mesothelin and EGFRvIII (JNJ-64041757), in patients with non-small cell lung cancer.
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