Immunomic Therapeutics, a U.S. subsidiary of HLB, received approval for phase 1 clinical trial plan from the U.S. FDA for “ITI-3000”, a Merkel cell carcinoma treatment

Merkel cell cancer is one of the rare and aggressive skin cancers caused by malignant changes in Merkel cells located near peripheral nerves in the upper part of the skin. Merkel cancer cells are known to be growing fast and metastasizing well, making it a very difficult disease to treat. Polyomavirus infection is pointed out as the main cause of the onset of Merkel cell cancer.

ITI-3000 is an anti-cancer vaccine made fusing a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV) with LAMP1 (lysosomal-associated membrane protein) based on Immune's cell therapy vaccine platform "UNITE." Antigens to which LAMP1 is applied are more efficiently presented to immune cells (CD4+T Cells) through antigen-presenting cells such as dendritic cells, leading to effective movement and strong immune responses of killer T cells and promoting cytokines such as interferon gamma (IFN)) to improve tumor microenvironment.

As Immunomic has obtained clinical approval from the FDA, it plans to quickly recruit patients and proceed with the medication process. Through phase 1 clinical trials conducted at the Fred Hutchison Cancer Research Center in Seattle, USA, they will evaluate the safety, tolerability, and immunogenicity of ITI-3000 in patients that have undergone surgery.

“Following the glioblastoma treatment "ITI-1000", "ITI-3000" was also approved by the FDA for clinical trials. This proves the outstanding performance of the UNITE platform" said an HLB official.
 
Immunomic is a biotechnology company established in Maryland, USA in 2006, and developed proprietary investigational lysosomal targeting technology “UNITE” in collaboration with Johns Hopkins University and Duke University. In 2018, it was selected as the best company at the World Vaccine Congress, which is recognized as the most prestigious company in the vaccine field.