The partners will conduct a Phase Ib clinical trial to assess the use of combinations of ABBV-368, tilsotolimod, nab-paclitaxel chemotherapy and/or ABBV-181 in triggering anti-tumour responses.
ABBV-368 is an OX40 agonist and ABBV-181 is an anti-programmed cell death 1 (PD-1) antagonist, while tilsotolimod has been designed as an agonist of toll-like receptor 9 (TLR-9).
Idera designed tilsotolimod for intratumoral administration to induce an immune response within the tumour microenvironment. The therapeutic is expected to boost the anti-tumour activity of checkpoint inhibitors such as anti-PD-1.
The multi-centre, open-label Phase Ib trial will investigate the safety, tolerability, preliminary efficacy and pharmacokinetics of ABBV-368 plus tilsotolimod in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) patients.
During the study, patients will be treated with either ABBV-368 plus tilsotolimod, a combination of ABBV-368, tilsotolimod and nab-paclitaxel, or ABBV-368 plus tilsotolimod along with nab-paclitaxel and ABBV-181.
As part of the alliance, Idera will supply tilsotolimod to AbbVie, which will conduct the trial.
Idera Pharmaceuticals chief medical officer Elizabeth Tarka said: “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.”
In February this year, Idera completed patient enrolment in a Phase II expansion of the ILLUMINATE-204 trial, which is evaluating tilsotolimod in combination with Bristol‑Myers Squibb’s ipilimumab (Yervoy).
The ILLUMINATE-204 study involves patients with unresectable or metastatic melanoma.