Immunomic Therapeutics, a subsidiary of HLB, said it has received U.S. Food and Drug Administration’s approval to conduct the phase 1 clinical trial of ITI-3000, a Merkel cell carcinoma treatment.

ITI-3000 is an anticancer vaccine made by combining LAMP1 (lysosomal-associated membrane protein) with the large T antigen of polyomavirus based on Immunomic's cell therapy vaccine platform UNITE. The treatment allows more efficient delivery of antigens applied with LAMP1 to immune cells through antigen-presenting cells such as dendritic cells, leading to effective migration of killer T cells and strong immune response.

It also improves the tumor microenvironment by promoting the secretion of cytokines such as interferon-gamma (IFNγ).

Merkel cell carcinoma is one of the rare and aggressive skin cancers caused by the malignant change of Merkel cells located near the peripheral nerves in the upper layer of the skin. In most cases, polyomavirus infection is the main cause of the development of Merkel cell carcinoma.

With the approval, Immunomic will accelerate patient recruitment and medication procedures to conduct a trial to confirm the treatment's safety, immunogenicity, and tolerability in Merkel cell cancer patients who have undergone surgery at the Fred Hutchison Cancer Research Center in Seattle, U.S.

"The U.S. phase 2 clinical trial of ITI-1000, a glioblastoma treatment developed based on UNITE platform, is progressing smoothly, and we could increase the scalability of the UNITE platform by receiving additional investigational new drug (IND) approval for ITI-3000," a company official said.

The official added that HLB would actively support Immunomics to rapidly develop various cell therapy anticancer drugs with excellent efficacy in various cancer types.