Idera Pharmaceuticals Announces Initiation of the ILLUMINATE-206 Trial Evaluating Tilsotolimod in Combination with Nivolumab and Ipilimumab for the Treatment of Solid Tumors
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
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
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Harnessing the approach of the earliest researchers in immunotherapy and the Company’s vast experience in developing proprietary immunology platforms, Idera’s lead development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy.
Idera Forward Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws including statements regarding our expectations for the ILLUMINATE-206 Trial. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, clinical trials, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
*Yervoy (ipilimumab) and Opdivo (nivolimumab) are registered trademarks of Bristol-Myers Squibb.
Idera Pharmaceuticals Contact:
SVP, Investor Relations
Phone (484) 348-1677
rdoody@iderapharma.com
Source: Idera Pharmaceuticals, Inc.