Date: 2015-07-29
Type of information: Clinical research agreement
Compound: mogamulizumab and Opdivo® (nivolumab)
Company: BMS (USA - NY) Kyowa Hakko Kirin (Japan)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody/immune checkpoint inhibitor Mogamulizumab is a novel, humanized mAb directed against CC chemokine receptor 4 (CCR4). Engineered by Kyowa Hakko Kirin\'s unique 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 adult T-cell leukemia-lymphoma (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 T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014, and with chemotherapy-native CCR4-positive ATL in December 2014. Clinical trials with mogamulizumab are ongoing in the US, EU and other countries. Opdivo® (Nivolumab) is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. PD-1, a receptor expressed on the surface of lymphocytes, plays a role in a regulatory pathway that suppresses activated lymphocytes in the body. Available evidence suggests that cancer cells exploit this pathway to escape from immune responses. Opdivo® is thought to provide benefit by blocking PD-1-mediated negative regulation of lymphocytes (i.e., the interaction of PD-1 with its ligands PD-L1 and PD-L2), thereby enhancing the ability of the immune system to recognize cancer cells as foreign and eliminate them. Opdivo® is the world’s first approved drug targeting PD-1. 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. In December 2014, the FDA approved Opdivo® (nivolumab) injection, for intravenous use for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Disease: advanced or metastatic solid tumors
Details: * On July 29, 2015, Kyowa Hakko Kirin and BMS announced that the companies have entered into a clinical trial collaboration agreement to conduct a Phase 1/2 combination study with mogamulizumab, an anti-CCR4 antibody and Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor. The study, which will be conducted in the U.S., will focus on evaluating the safety, tolerability and anti-tumor activity of combining mogamulizumab and Opdivo as a potential treatment option for patients with advanced or metastatic solid tumors. Prior to this agreement, Kyowa Hakko Kirin, Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. (Tokyo: 4528) entered into a clinical trial collaboration agreement to study the combination of mogamulizumab and Opdivo in Japan. “Today’s agreement builds on our initial collaboration with Kyowa Hakko Kirin in Japan, which includes our partner Ono Pharmaceutical Co., Ltd., and is the latest example of our continued commitment to evaluating the potential of combination immuno-oncology regimens for patients with metastatic cancer,” stated Michael Giordano, senior vice president, Head of Development, Oncology, BMS. The study will be conducted by Kyowa Hakko Kirin. Additional details of the collaboration were not disclosed.
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