Clinical Trials

Date: 2017-12-13

Type of information: Recruitment of the first patient

phase: 1

Announcement: recruitment of the first patient

Company: Iovance Biotherapeutics (USA - CA) tumor-infiltrating lymphocyte (TIL)

Product: nivolumab and tumor-infiltrating lymphocyte (TIL)

Action mechanism:

tumor-infiltrating lymphocyte (TIL)/cell therapy/immunotherapy product/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. 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.

Disease: advanced non-small cell lung cancer (NSCLC)

Therapeutic area: Cancer - Oncology

Country:

Trial details:

The Phase 1 TIL and nivolumab combination study is being conducted in collaboration with the Moffitt Cancer Center, Stand Up To Cancer, as well as support from Bristol-Myers Squibb and Prometheus Laboratories, and speaks to the potential application of TIL technology in lung cancer. The istudy is designed to enroll up to 18 patients. (NCT03215810)

Latest news:

• On December 13, 2017, Iovance Biotherapeutics announced that patient enrollment has begun in a study combining TIL and nivolumab in advanced non-small cell lung cancer (NSCLC) patients in collaboration with researchers at H. Lee Moffitt Cancer Center and Research Institute (Moffitt), Stand Up to Cancer and other partners.