Idera Pharmaceuticals announces initiation of ILLUMINATE-206 trial
Idera Pharmaceuticals announced the initiation of a phase 2 trial, ILLUMINATE-206 which will evaluate tilsotolimod, a toll-like receptor 9 agonist, in combination with nivolumab, a programmed death receptor-1 blocking antibody, and ipilimumab, a human cytotoxic T-lymphocyte antigen 4 blocking antibody for the treatment of solid tumors. The primary objective of this phase 2, open-label, global, study is to demonstrate efficacy. Secondary and exploratory objectives include safety, tolerability, immunogenicity and translational data evaluations. The initial cohort of the trial will be patients with immunotherapy-naive Microsatellite Stable Colorectal Cancer. The second planned cohort of ILLUMINATE-206 will focus on treating patients with anti-PD-1 refractory Squamous Cell Carcinoma of the Head and Neck, which will initiate in the fourth quarter of this year. The basis for this trial is supported by data generated from the ILLUMINATE-101 trial, which studied intratumoral tilsotolimod monotherapy in 45 evaluable patients with a variety of solid tumor types in which 33% achieved stable disease. Translational research in ILLUMINATE-101, demonstrated that tilsotolimod increased dendritic cell activation and upregulated MHC class II and IFN-alpha signaling which suggests improved antigen presentation. These findings are consistent with those observed in the ILLUMINATE-204 trial in anti-PD-1 refractory metastatic melanoma patients. Therefore, the mechanism of action for tilsotolimod may be tumor-type agnostic and potentially beneficial in combination with checkpoint modulation in a variety of tumor types.