IGN002 is an investigational immunotherapy being developed by ImmunGene, in collaboration with the Leukemia and Lymphoma Society (LLS), to treat patients with non-Hodgkin’s lymphoma (NHL) who have run out of treatment options. It combines a monoclonal antibody with interferon (IFN), a protein that plays an important role in regulating the immune system.
How IGN002 works
IGN002 combines a monoclonal antibody targeted against CD20, a protein found on the surface of most B-cell blood cancers, with IFN. Interferon is a cytokine, a protein that acts as a chemical messenger among immune cells to coordinate immune responses. IFN can also be used on its own to treat cancers.
Due to its CD20-binding capacity, IGN002 is designed to carry IFN directly to cancer cells, where it binds to the IFN receptor and sets off several different anti-cancer effects that work to both slow tumor progression and cause cancer cell death.
IGN002 in clinical trials
An ongoing open-label, two-part Phase 1 clinical trial (NCT02519270) is testing the safety and tolerability of IGN002 in NHL patients. Dosing in a first patient began in June 2016.
In the dose-escalation first part of this study, patients are grouped in cohorts, with each cohort receiving a higher dose if the previous dose was well-tolerated. All will receive multiple intravenous (IV) doses of IGN002 once a week, for a total of up to 26 doses. The purpose is to find the safest highest dose, or the maximum tolerated dose (MTD), of the drug.
In part two, the expansion part of the study, patients will receive up to 24 injections of IGN002 at the safe dose established in the trial’s first part.
The trial, which expects to enroll 62 people, will continue through 2018 and is now recruiting at its three U.S. test sites. Patients included in the study must have laboratory-confirmed CD20-positive lymphoma, meaning the protein CD20 is expressed on the surface of the cancer cells.
A Phase 2 trial (NCT02847949) is set to include participants from the Phase 1 trial who were seen to ably tolerate and benefit from IGN002. This study also plans to enroll 62 patients at the same three test sites — in California, Florida and Texas — as the Phase 1 study, but it is not yet open for enrollment.
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