On September 4, 2019 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) reported that they have entered into an immuno-oncology clinical research collaboration with AbbVie, a global, research-based biopharmaceutical company (Press release, Idera Pharmaceuticals, SEP 4, 2019, View Source [SID1234539270]). The purpose of the collaboration is to conduct a clinical study evaluating whether combinations of an OX40 agonist (ABBV-368), a TLR-9 agonist (tilsotolimod), chemotherapy (nab-paclitaxel) and/or an anti-programmed cell death 1 (PD-1) antagonist (ABBV-181) stimulate the immune system resulting in anti-tumor responses.
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This Phase 1b, multi-center, open-label study is designed to determine the safety, tolerability, pharmacokinetics and preliminary efficacy of combinations of ABBV-368 plus tilsotolimod in subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The study will test three separate treatment arms:
ABBV-368 plus tilsotolimod;
ABBV-368 plus tilsotolimod and nab-paclitaxel; and
ABBV-368 plus tilsotolimod, nab-paclitaxel and ABBV-181.
Under the terms of the agreement, Idera will provide clinical trial supply of tilsotolimod to AbbVie and AbbVie will be responsible for conduct of the study.
"We are excited to be entering into this additional clinical collaboration, which continues to advance our strategy of exploring the possibilities to further improve patient outcomes harnessing the immune system against difficult to treat cancers, which historically have not generated significant objective response rates through checkpoint inhibition alone," stated Elizabeth A. Tarka, M.D., F.A.C.C., Idera’s Chief Medical Officer. "We look forward to working together with AbbVie to advance our understanding of the combination effect of ABBV-368 and tilsotolimod for these patients."