Date: 2016-12-20
Type of information: Clinical research agreement
Compound: nivolumab and TIL (tumor infiltrating lymphocyte) therapy
Company: Lion Biotechnologies (USA - CA) H. Lee Moffitt Cancer Center and Research Institute (USA - Fl)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism:
- cell therapy/immunotherapy product/monoclonal antibody/immune chekcpoint 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. 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. Nivolumab 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. This 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.
- Tumor infiltrating lymphocytes (TIL) have the capacity to recognize and attack the tumor traffic and infiltrate into the tumor. However, the anti-tumor effect of these cells is usually short-lived because cancer cells adapt and suppress the anti-tumor immune response through the release of various anti-inflammatory factors into the local environment. Here, TIL are first extracted from the patient and expanded in tissue culture with IL-2. Then the amplification process eliminates the immune-suppressive environment created by the tumor which is so effective at neutralizing the natural anti-tumor immune response. Third, this same culture environment optimizes the replication and activation of aggressive anti-tumor TIL. Once sufficient numbers of cells with the appropriate anti-tumor potential have been cultured, they are then re-administered back into the donor patient where they have been shown to mediate impressive anti-tumor responses.
Disease: metastatic melanoma
Details:
- • On December 20, 2016, Lion Biotechnologies announced that it has entered into a new three-year sponsored research agreement with the H. Lee Moffitt Cancer Center and Research Institute. At the same time, Lion Biotechnologies also announced that it has entered into a clinical grant agreement with the H. Lee Moffitt Cancer Center and Research Institute Hospital to support an ongoing clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with metastatic melanoma.
- The Sponsored Research Agreement will have a three-year term. Areas of research will include an evaluation of the role of individual effector cells in the expansion of TIL from primary solid tumors; the use of toll-like receptor (TLR) ligands in the expansion of TIL from solid tumors; optimal expansion of TIL from various solid tumors and phenotype and function analysis of patient blood and tumor samples from clinical trials.
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