On September 30, 2019 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) reported the initiation of a phase 2 trial, ILLUMINATE-206 which will evaluate tilsotolimod, a toll-like receptor 9 (TLR9) agonist, in combination with nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and ipilimumab, a human cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody for the treatment of solid tumors (Press release, Idera Pharmaceuticals, SEP 30, 2019, View Source [SID1234539939]).
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The primary objective of this phase 2, open-label, global, study is to demonstrate efficacy (measured by overall response rate [ORR] based on RECIST v.1.1). 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 (MSS-CRC). The second planned cohort of ILLUMINATE-206 will focus on treating patients with anti-PD(L)-1 refractory Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN), which will initiate in the fourth quarter of this year.
"Initiation of this Phase 2 study is an important step toward understanding the broader applications of tilsotolimod," stated Elizabeth A. Tarka, M.D., F.A.C.C., Idera’s Chief Medical Officer. "Demonstrating the potential benefit of tilsotolimod in patients with specific solid tumors where the disease setting under investigation have no approved immunotherapies, would be a significant contribution to the treatment paradigm."
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% (n=15) achieved stable disease. Translational research in ILLUMINATE-101, demonstrated that tilsotolimod increased dendritic cell activation and upregulated MHC class II and IFN-α 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.
A poster presentation from ILLUMINATE-101 is being presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain today and can be found in the Key Publications section of Idera’s Corporate website, www.iderapharma.com.
On March 11, 2019, Idera and Bristol-Myers Squibb (BMS) entered into a clinical trial collaboration and supply agreement in which BMS has agreed to supply YERVOY* (ipilimumab) and OPDIVO (nivolumab) for no charge for use in ILLUMINATE-206.