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news.Idera Pharmaceuticals has established a strategic clinical research collaboration with The University of Texas MD Anderson Cancer Center to enhance clinical development of intratumoral TLR9 agonist in combination with checkpoint inhibitors.
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IMO-2125 is a TLR9 agonist that was assessed subcutaneously in around 80 human subjects. It was well tolerated and demonstrated to induce immune responses.
Idera Pharmaceuticals CEO Vincent Milano said: "Being chosen as a strategic research alliance partner by MD Anderson, a world-leading cancer research center to advance the clinical development of intratumoral TLR9 agonists in combination with check-point inhibitors is an important step forward for Idera’s oncology program."
Under the research alliance, the company plans to start the Phase I/II study to evaluate the safety and efficacy of Intratumoral IMO-2125 in combination with ipilimumab (a CTLA4 antibody) in patients with metastatic melanoma.
In the study, escalating doses of IMO-2125 will be administered intratumorally into a lesion, with a standard dosing regimen of ipilimumab.
According to the firm, the primary objectives of the study will be to determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLTs) of IMO-2125 when administered intratumorally in combination with ipilimumab.
The trial will also determine the efficacy of the combination utilizing the immune-related response criteria (irRC).
Idera plans to begin the clinical study in the second half of this year and will enroll around 45 patients, while the company is expecting the data from the trial in 2016.