HLB Successfully Completes Phase 1 Clinical Trial of Rare Skin Cancer Treatment Vaccine 'ITI-3000'

HLB announced on the 26th that its U.S. subsidiary Immunomic Therapeutics has confirmed both the safety and efficacy of the anticancer vaccine 'ITI-3000' in a Phase 1 clinical trial conducted in the United States targeting patients with Merkel cell carcinoma (MCC), a rare skin cancer.

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Photo by Immunomic Therapeutics

Clinical results showed that ITI-3000 has no dose-dependent toxicity and no adverse reactions during treatment, confirming its high safety profile. This Phase 1 trial was conducted by administering 4 mg of the ITI-3000 vaccine once a month for four months to evaluate the safety, tolerability, and immunological response of ITI-3000.

ITI-3000 is an anticancer vaccine developed by combining the mutated nucleotide sequence of the large T antigen of the polyomavirus that causes Merkel cell carcinoma with the nucleotide sequence of the ‘LAMP (lysosomal-associated membrane protein) 1’ gene, based on Immunomic’s cell therapy vaccine platform ‘UNITE’. It was designated as a fast track drug by the U.S. Food and Drug Administration (FDA) in November last year.

In preclinical studies conducted earlier, ITI-3000 was confirmed to induce a strong anticancer immune response by acting on helper T cells (CD4+ T cells), which activate and direct other immune cells. The company explained that it notably increased the numbers of powerful immune cells such as CD8+ T cells and natural killer (NK) cells, and also effectively improved the tumor microenvironment (TME) that inhibits immune cell activity.

Donggeon Kim, CEO of Immunomic and head of HLB USA, said, “The results of this Phase 1 clinical trial are a very important achievement for the Immunomic research team who have been striving to develop treatment solutions for rare cancers. Since the high therapeutic efficacy and safety of the UNITE platform have been confirmed through the ITI-3000 trial, we will accelerate subsequent clinical trials of ITI-3000 by utilizing the fast track system.”

This content was produced with the assistance of AI translation services.