Focused on Proving Solutions for Significant Unmet Needs

Our lead product candidate, tilsotolimod, has demonstrated activity in a large array of pre-clinical models and is now demonstrating proof of concept in patients through both clinical and translational outcomes in PD-1 refractory melanoma patients.

Our Pipeline

Program
Mechanism Indication Partner/ Collaborator Discovery Phase 1 Phase 2 Pivotal
IMMUNO-ONCOLOGY
TLR9 Agonist ILLUMINATE 204 - IPI Combo Phase 2
ILLUMINATE 204 - PD1 Combo Phase 1
ILLUMINATE 101 Phase 1
ILLUMINATE 301 Pivotal
PARTNERED PROGRAMS
TLR9 Agonist ILLUMINATE-206 (SCCHN/MSS-CRC) Phase 2
3GA 3GA Renal Diseases Discovery
PARTNERING OPPORTUNITIES
TLR 7,8,9 Antagonist IMO-8400 Phase 1
TLR 7,8,9 Antagonist IMO-9200 Phase 1
IMMUNO-ONCOLOGY
PARTNERED PROGRAMS
TLR9 Agonist
3GA
Discovery
PARTNERING OPPORTUNITIES
TLR 7,8,9 Antagonist
Phase 1
TLR 7,8,9 Antagonist
Phase 1

ILLUMINATE CLINICAL DEVELOPMENT PROGRAM

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 ILLUMINATE-301, 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 tilsotolimod with an Ipilimumab (anti-CTLA4 antibody) in patients with PD-1 refractory metastatic melanoma.   We have recently completed enrollment in a second multi-center Phase two trial (ILLUMINATE-204) 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 completing Phase 1 dose escalation.

We’re also actively conducting a clinical trial (ILLUMINATE-101) of tilsotolimod monotherapy in other solid tumor types, including melanoma.  This trial is currently recruiting patients at approximately 8 locations in the United States.

The company is planning to soon initiate the ILLUMINATE-206 trial which will test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab in treating patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Microsatellite Stable Colorectal Cancer (MSS-CRC).

Tilsotolimod (IMO-2125) has been granted both Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).

  • Clinical Programs

    Read about our ongoing and planned clinical trials for treating rare cancers and other rare diseases such as metastatic melanoma and dermatomyositis.