|Partnering Opportunities – Idera-Sponsored Clinical Development Suspended||
Intratumoral Tilsotolimod (IMO-2125) for Metastatic Melanoma and Beyond
We are conducting several clinical trials with intratumoral delivery of our TLR9 agonist, tilsotolimod, in combination with checkpoint inhibitors—the currently approved treatment for several solid tumor types. Our most advanced clinical trial is currently in Phase 3 and enrolling patients with anti-PD-1 refractory metastatic melanoma at approximately 80 global sites. This trial is testing the efficacy of the combination of intratumoral IMO-2125 with an Ipilimumab (anti-CTLA4 antibody) in patients with PD-1 refractory metastatic melanoma. We also have a second multi-center Phase two trial running in parallel combining tilsotolimod in combination with ipilimumab in anti-PD-1 refractory melanoma. This trial also has a separate arm testing the combination of IMO-2125 with pembrolizumab (PD-1-blocking antibody). The pembrolizumab arm is currently in Phase 1 dose escalation.
We’re also actively conducting a clinical trial of IMO-2125 monotherapy in other solid tumor types, including melanoma. This trial is currently recruiting patients at approximately 8 locations in the United States.
Tilsotolimod (IMO-2125) has been granted both Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).
IMO-8400 for Rare Diseases
Idera is also advancing the development of IMO-8400 in a rare disease with high unmet clinical need where over-activation of TLRs has been implicated in the disease pathogenesis. We have prioritized near-term development in dermatomyositis, an inflammatory muscle disease with skin involvement. We are currently enrolling in a multi-national, multi-center, double-blind placebo-controlled Phase 2 clinical trial with completion of enrollment expected in the second half of 2017 and data available in the first half of 2018.
Third Generation Antisense (3GA) Technology Platform
Based on our leadership and scientific expertise in nucleic acid therapeutics, Idera has developed a third-generation antisense platform using gene silencing oligonucleotides (GSOs). This novel technology has been rationally designed to overcome limitations of current antisense platforms, and we have differentiated GSOs from other antisense approaches in pre-clinical models. To date we have generated 22 unique compounds for specific gene targets across a large array of disease indications, which enables an engine for development growth for our own internal aspirations as well as a pipeline of opportunities for partnerships. We have selected an undisclosed liver target as our first clinical development focus and expecting to complete comparative animal testing in the 1st quarter of 2018 with a strategic advancement decision based upon those results in the 2nd quarter of 2018. In parallel we also have a licensing collaboration with GSK for an undisclosed renal target, with an expected goal of clinical candidate selection in the first quarter of 2018.