Immunomic Therapeutics, the U.S. subsidiary of HLB, announced on January 19 that it has received U.S. Food and Drug Administration (FDA) approval to begin clinical trials for its novel cancer vaccine candidate, ITI-5000.
The FDA has cleared the investigational new drug (IND) application for a phase 1 study of ITI-5000, a self-amplifying RNA (saRNA) cancer vaccine developed using Immunomic’s proprietary UNITE immunotherapy platform. With this approval, ITI-5000 will now enter its first clinical trial in humans.
Designed to enhance the immune system’s ability to recognize tumors, ITI-5000 delivers tumor antigens directly into lysosomes—cellular structures responsible for processing substances and presenting them to immune cells. By binding tumor antigens to the LAMP-1 protein, the vaccine effectively targets CD4+ T cells, which coordinate a broader immune response. Activated CD4+ T cells stimulate B cells to produce antibodies and CD8+ T cells to attack cancer cells, creating a multi-layered anticancer response.
The phase 1 study, named VITALITI, will focus on patients with stage 2–3 triple-negative breast cancer, a form of the disease known for limited treatment options and high recurrence risk. The trial will evaluate ITI-5000 as a monotherapy and in combination with the immunotherapy pembrolizumab, assessing safety, tolerability, and early immune responses.
In the combination regimen, ITI-5000 initiates the immune response, while pembrolizumab blocks the PD-1 pathway, preventing immune suppression and sustaining the response. The open-label, multicenter study will take place across up to eight U.S. medical institutions, with patient enrollment expected to begin in the second quarter of 2026.
Kim Dong-gun, head of Immunomic, said, “This clinical approval builds on years of accumulated research and brings us into the clinical stage. We aim to determine whether ITI-5000 can offer a new treatment approach for triple-negative breast cancer.”
The UNITE platform underpins ITI-5000, enabling immune cells to efficiently recognize specific cancer antigens via LAMP-family proteins. Unlike conventional immunotherapies that rely on immune checkpoint protein expression, UNITE directly activates the immune system against tumor antigens, showing potential for application across multiple cancer types.
