Date: 2016-07-26
Type of information: Clinical research agreement
Compound: Opdivo® (nivolumab) and JNJ-64041757
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/immunotherapy product/cell therapy. 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. JNJ-64041757 is an antigen-presentation therapeutic, based on Live Attenuated Double-Deleted (LADD) Listeria monocytogenes strains engineered to induce an immune response against NSCLC tumors. Janssen licensed JNJ-64041757 (previously referred to as ADU-214) and another compound, JNJ-64041809 (previously referred to as ADU-741), from Aduro Biotech in 2014. Both are currently in Phase 1 clinical development: JNJ-64041757 in lung cancer and JNJ-64041809 in prostate cancer.
Disease: non-small cell lung cancer (NSCLC)
Details: * On July 26, 2016, Janssen Biotech announced it has entered into a clinical study collaboration agreement with BMS to evaluate the combination of two immuno-oncology compounds in patients with non-small cell lung cancer (NSCLC). The Phase 2 clinical trial will evaluate the tolerability and clinical activity of the combination of Janssen’s investigational immunotherapy JNJ-64041757 and BMS’ Opdivo® (nivolumab), in NSCLC patients. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
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