Immunomic Therapeutics, HLB’s U.S. subsidiary, wins FDA clearance for Phase 1 trial of triple-negative breast 바카라사이트 기가 vaccine

[by Kang, In Hyo] Immunomic Therapeutics (hereinafter referred to as Immunomic), a U.S. subsidiary of HLB, announced on January 19 that the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for the Phase 1 clinical trial of ITI-5000 (development code). ITI-5000 is a self-amplifying RNA (saRNA)-based anticancer vaccine candidate developed using Immunomic’s proprietary immunotherapy vaccine platform, UNITE.

ITI-5000 is an anti바카라사이트 기가 vaccine candidate engineered to facilitate efficient antigen presentation to CD4+ T cells through the MHC class II pathway by fusing with lysosome-associated membrane protein 1 (LAMP-1), a protein located in the lysosomal membrane, which directs the antigen to lysosomes via LAMP-1-mediated lysosomal targeting signals. Through this process, the vaccine is designed to effectively induce CD4+ T cell-driven immune activation and subsequent antibody production. According to the company, activated CD4+ T cells simultaneously support B cell-mediated antibody responses while promoting CD8+ cytotoxic T cell responses, thereby generating a multi-layered antitumor immune response.

The U.S. Phase 1 clinical trial (VITALITI) is a multicenter, open-label, Phase 2, first-in-human clinical trial designed to assess the safety, tolerability, and preliminary immunological activity of ITI-5000 administered as monotherapy and in combination with pembrolizumab in patients with Stage II-III triple-negative breast 바카라사이트 기가 (TNBC). Immunomic plans to initiate patient enrollment in the second quarter, with participation expected from up to eight clinical trial sites across the United States.

Breast 바카라사이트 기가 ranks as the fifth leading cause of 바카라사이트 기가-related mortality worldwide. Among its subtypes, triple-negative breast 바카라사이트 기가 (TNBC) accounts for approximately 15-20% of all breast 바카라사이트 기가 cases and is associated with substantial unmet medical need, owing to the scarcity of effective treatment options and its generally poor prognosis.

ITI-5000 activates a CD4+ T cell-centered immune response that serves as a foundational driver of antitumor immunity, while pembrolizumab enhances and sustains immune activity by restoring the function of previously activated immune cells through PD-1 inhibition. Accordingly, the combination therapy of ITI-5000 and pembrolizumab is anticipated to generate synergistic effects in inducing and maintaining antitumor immune responses.

Previously, Immunomic demonstrated the safety and immune-activating properties of ITI-5000 through non-clinical studies, establishing a robust scientific basis for entering human clinical trials. "ITI-5000 exemplifies the technological advancement of the UNITE platform through LAMP-1-mediated antigen presentation. This achievement reflects the sustained efforts and long-term research conducted by our internal R&D team to advance the program into clinical trials, and we expect it to introduce a novel therapeutic approach for patients with triple-negative breast cancer," said Kim Dong-gun, CEO of Immunomic Therapeutics.

On the other hand, the UNITE platform is a proprietary technology engineered to rapidly and efficiently activate immune cells by binding tumor-specific antigens to lysosomal-associated membrane proteins (LAMPs). In contrast to conventional immunotherapies, whose clinical efficacy is often constrained by the expression levels of ‘immune checkpoint proteins,’ the UNITE platform is regarded as an innovative and highly extensible technology, as it directly induces ‘antigen-based immune responses’ and can be broadly applied to various cancer types.