The study is being conducted at The University of Texas MD Anderson Cancer Center and is being led by Adi Diab, MD, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, MD Anderson.
In this clinical trial, escalating doses of IMO-2125 ranging from 4 mg/kg through 32 mg/kg will be administered intra-tumorally into one of two selected tumor lesions, with a standard dosing regimen of ipilimumab.
The primary objectives of the phase 1 portion of the trial will be to determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLTs) of IMO-2125 when administered intra-tumorally in combination with ipilimumab. The primary objective of the phase 2 portion will be to determine the efficacy of the combination utilizing the immune-related response criteria (irRC) in additional to traditional RECIST criteria.
Serial biopsies will be taken of selected injected and non-injected tumor lesions to assess immune changes and response assessments. The trial will enroll approximately 45 patients. The company expects initial data from the ongoing trial to be available in 2016.
Preclinical evidence shows that IMO-2125 delivered intra-tumorally in combination with anti-CTLA-4 mAb demonstrates improved inhibition of tumor growth, regression of metastases and infiltration of the number and nature of tumor specific immune cells in injected and non-injected tumor lesions versus monotherapy with either agent.
Additional pre-clinical evidence suggests that intra-tumoral IMO-2125 modulates checkpoint gene expression, including IDO1, PDL1, TIM3, LAG3 and CTLA4, in both treated and distant tumor nodules. The company is currently considering additional clinical studies to evaluate IMO-2125 in combination with other select checkpoint inhibitors.
Idera chief medical officer Joanna Horobin said: "We are eager to demonstrate translation of the compelling preclinical data into the clinical setting with this novel approach to cancer immunotherapy with intra-tumoral IMO-2125.
"The momentum and enthusiasm among our team along with our research alliance partner, MD Anderson is very strong. This is a beginning step in a broad strategy to demonstrate a major advancement in efficacy and safety over existing treatment regimens."
"We are anxious to understand whether the local immune changes observed in the injected tumor will be transferred to non-injected tumor lesions and that both will correlate with improved clinical efficacy for our patients," stated Dr. Diab.