Immunomic Therapeutics, the U.S. subsidiary of HLB, received U.S. Food and Drug Administration (FDA) approval to begin clinical trials for its cancer vaccine candidate.
Immunomic said on the 19th that the FDA approved the investigational new drug (IND) application for a phase 1 trial of ITI-5000, a self-amplifying RNA (saRNA) cancer vaccine candidate based on its proprietary immunotherapy vaccine platform "UNITE." With this approval, ITI-5000 will enter its first clinical trial in humans.
ITI-5000 is a cancer vaccine designed to help immune cells better recognize tumors. It precisely delivers tumor antigens into a structure inside the cell called a "lysosome," inducing an immune response. Lysosomes enable immune cells to process external substances and present them to other immune cells.
The candidate is designed to move tumor antigens into lysosomes by binding them to a protein called LAMP-1. In this process, the tumor antigens are effectively delivered to CD4+ T cells, which are key cells that act as the "conductor" of the immune response. When CD4+ T cells are activated, B cells that produce antibodies and CD8+ T cells that directly attack cancer cells are also activated, inducing a more multi-layered anticancer immune response.
The phase 1 trial will proceed under the name "VITALITI." In patients with stage 2–3 triple-negative breast cancer, it will compare ITI-5000 monotherapy with combination therapy with the immunotherapy pembrolizumab to evaluate safety, tolerability and initial immune responses. Triple-negative breast cancer is known to have limited treatment options and a high risk of recurrence.
In the combination regimen, the two drugs play different roles. ITI-5000 triggers the starting point of the immune response, while pembrolizumab blocks the PD-1 pathway that suppresses immune cell function to help maintain the immune response once activated. The approach aims to induce and sustain the immune response at the same time.
The trial will be a multicenter, open-label study at up to eight medical institutions in the United States, and Immunomic plans to begin enrolling patients in the second quarter of this year.
Kim Dong-gun, head of Immunomic, said, "This clinical approval builds on years of accumulated research results moving into the clinical stage," adding, "We will work to verify whether this can become a new approach in treating triple-negative breast cancer."
Meanwhile, the UNITE platform is a technology designed to enable immune cells to recognize specific antigens that appear in cancer quickly and efficiently by binding them to LAMP-family proteins. While existing immunotherapies can be limited depending on the expression level of immune checkpoint proteins, this platform directly induces an immune response based on the antigens themselves, and is evaluated as a technology with potential to expand to various cancer types.