Immunomic Begins Dosing First Patient in U.S. Phase 1 Trial of Cancer Vaccine "ITI-5000"

Immunomic Therapeutics, the U.S. subsidiary of HLB, has begun dosing the first patient in the United States in a Phase 1 clinical trial (VITALITI) of its triple-negative breast cancer (TNBC) therapeutic vaccine candidate, "ITI-5000."

According to Immunomic on July 20, the first patient was dosed in the Phase 1 trial of ITI-5000 at a clinical institution in the U.S. on July 16, local time. Since receiving Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) in January, Immunomic has prepared the clinical site and conducted patient screening and enrollment procedures, leading up to the actual dosing stage.

This Phase 1 clinical trial is a first-in-human, multicenter, open-label study to evaluate the safety, tolerability, and initial immunological activity of ITI-5000 in patients with stage 2–3 triple-negative breast cancer. The study will assess ITI-5000 both as a monotherapy and in combination with the current standard adjuvant therapies.

ITI-5000 is an anti-cancer vaccine candidate developed independently by Immunomic, based on its proprietary immunotherapy vaccine platform "UNITE" and utilizing self-amplifying RNA (saRNA) technology. It is designed to induce a T-cell-based anti-cancer immune response by targeting CT83 and HERV-K, tumor antigens expressed in triple-negative breast cancer.

The UNITE platform is a technology that efficiently delivers tumor antigens to immune cells, activates CD4+ T cells, and thereby stimulates multiple anti-cancer immune responses, including activating CD8+ T cells that attack cancer cells and inducing antibody production.

Dong Gun Kim, CEO of Immunomic Therapeutics, stated, "The administration of ITI-5000 to the first patient marks a significant milestone, signaling the full-scale launch of the clinical development for ITI-5000." He added, "Through these trials, we aim to confirm the safety and immune response of ITI-5000 and demonstrate its potential as a next-generation therapeutic cancer vaccine."

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