Clinical Trials

Date: 2017-02-24

Type of information: Presentation of results at a congress

phase: 1-2

Announcement: presentation of results at the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium

Company: Idera Pharmaceuticals (USA - CA)

Product: IMO-2125 in combination with ipilimumab or pembrolizumab

Action mechanism:

monoclonal antibody/immune checkpoint inhibitor/TLR9 agonist. Idera's TLR9 agonist, IMO-2125 has been shown to activate dendritic cells and induce interferon. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this immunological profile.

Disease: patients with metastatic melanoma with disease that is refractory to PD-1 inhibitors.

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

The goal of this clinical research study is to find the highest tolerated dose of the study drug IMO-2125 that can be given in combination with ipilimumab or in combination with pembrolizumab to patients with metastatic melanoma. Researchers also want to learn if the study drug combination can help to control the disease. The safety of the drug combination will also be studied. This is an open-label Phase 1/2 study to determine the maximum tolerated dose (MTD) and assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of IMO-2125 when administered in combination with ipilimumab or pembrolizumab. The study will be conducted in 2 parts; a dose-escalation portion (Phase 1) to evaluate safety and tolerability of multiple dose levels and a Phase 2 portion to assess efficacy. (NCT02644967)

Latest news:

• On February 24, 2017, Idera Pharmaceuticals reported data from the dose-escalation phase of its ongoing Phase 1/2 clinical trial of intratumoral IMO-2125 in combination with ipilimumab or pembrolizumab for treatment of patients with metastatic melanoma with disease that is refractory to PD-1 inhibitors. In the poster presentation at the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium, entitled, "Intratumoral (i.t.) IMO-2125, a TLR9 agonist is active in combination with ipilimumab (ipi) in PD-(L)1 refractory melanoma (RM)," Marc Uemura , M.D. from the University of Texas , MD Anderson Cancer Center , presented an update on the clinical and translational findings from the ongoing trial. Data showed that combination of IMO-2125 and ipilimumab has clinical activity in PD-1 refractory melanoma. There is evidence for immune activation in both the injected and distant tumor biopsies that correlates with clinical outcome. The planned Phase 2 expansion will begin soon and dose escalation of IMO-2125 + pembrolizumab is also ongoing.