Date: 2015-12-04
Type of information: Initiation of the trial
phase: 1b
Announcement: initiation of the trial
Company: Acetylon Pharmaceuticals (USA - MA)
Product: citarinostat (ACY-241) and nivolumab
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor/histone deacetylase inhibitor/HDAC inhibitor. Citarinostat, also known as ACY-241, is a elective and orally available histone deacetylase (HDAC) inhibitor, with potential antineoplastic activity. 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.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This phase 1b study is to determine the safety, tolerability, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD) of ACY 241 in combination with nivolumab. (NCT02635061)
Latest
news: * On December 4, 2015, a Phase 1b trial sponsored by Acetylon Pharmaceuticals was published on the NIH website ClinicalTrials.gov for ACY-241 and nivolumab and is currently recruiting participants.
