The U.S. Food and Drug Administration (FDA) has cleared Immunomic Therapeutics’ Investigational New Drug (IND) application for an RNA vaccine in patients with triple-negative breast cancer, the company shared in a recent press release.
The clearance permits Immunomic Therapeutics to begin its first clinical trial of ITI-5000 on its own and combined with pembrolizumab. The study will include individuals with Stage II and Stage III triple-negative breast cancer.
The trial will evaluate the safety and tolerability of ITI-5000, as well as analyze how the immune system reacts to the drug. Up to eight sites across the United States will participate in the study.
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When administered, ITI-5000 tells the body to produce tumor-associated proteins, helping the immune system to better recognize and destroy cancer cells. Pembrolizumab is a monoclonal antibody that inhibits the PD-1 protein, which also helps to activate immune responses.
The vaccine is part of Immunomic’s UNITE® technology, which uses molecular biology to retrain immune responses for a variety of conditions. Currently, the company is studying cancer, allergies, animal health and infections.
Previous studies in animal models have demonstrated the safety and efficacy of ITI-5000.
“Our preclinical findings provide strong scientific rationale for advancing ITI-5000 into human studies, particularly in a disease area where new therapeutic approaches are urgently needed,” explained chief scientific officer Teri Heiland.
Immunomic Therapeutics plans to begin recruiting participants during the second quarter of 2026.
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