Pipeline & Programs

Our Pipeline

Program	Mechanism Indication Commercial Rights Discovery Phase 1 Phase 2 Pivotal
IMMUNO-ONCOLOGY	TLR9 Agonist IMO-2125 Refractory PD-1 Metastatic Melanoma / IPI Comb. Phase 2 IMO-2125 Refractory PD-1 Metastatic Melanoma / PD-1 Comb. Phase 1 IMO-2125 Monotherapy Additional Tumor Types Phase 1 IMO-2125 Combo Additional Tumor Types – CPI Comb. Discovery
RARE DISEASES	TLR 7,8,9 Antagonist IMO-8400 Dermatomyositis Phase 2 3GA - Undisclosed Target Undisclosed Rare Liver Condition Discovery 3GA- NLRP3 3GA Undisclosed Indication Discovery 3GA- DUX4 3GA Undisclosed Indication Discovery
PARTNERED PROGRAMS	3GA 3GA Renal Diseases Discovery TLR 7,8,9 Antagonist IMO-9200 Autoimmune Diseases Phase 1
Partnering Opportunities – Idera-Sponsored Clinical Development Suspended	TLR 7,8,9 Antagonist IMO-8400 B-Cell Lymphoma Phase 1

Intratumoral IMO-2125 for Metastatic Melanoma and Beyond

We are conducting the first of several clinical trials with intratumoral delivery of our TLR9 agonist, IMO-2125, in combination with checkpoint inhibitors—the currently approved treatment for several solid tumor types.  Our most advanced clinical trial is currently in Phase 2 and enrolling patients with metastatic melanoma at five 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.  This trial also has a separate arm testing the combination of IMO-2125 with pembrolizumab (PD-1-blocking antibody).  This 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.

We are also in the planning stages of additional studies in other tumor types and with other checkpoint inhibitors.

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 are expecting to enter the clinic in the first 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.