HLB US Subsidiary Immunomic Initiates Phase 1 Clinical Trial for Glioblastoma Treatment Vaccine

HLB's U.S. subsidiary Immunomic Therapeutics announced on the 25th that it has begun patient dosing in Phase 1 clinical trials of its self-developed therapeutic vaccine ‘ITI-1001’ for newly diagnosed glioblastoma patients.

ITI-1001 is a pDNA vaccine developed for glioblastoma treatment based on Immunomic’s UNITE platform technology. It targets the PP65 protein of cytomegalovirus (CMV), a major cause of glioblastoma, activating dendritic cells, one of the key immune cells, to induce an effective and robust immune response.

The ongoing clinical trial at the Dana-Farber Cancer Institute in Boston, Massachusetts, aims to determine the optimal dose (8mg) of ITI-1001 as well as assess the drug’s safety and immunogenicity.

Glioblastoma is a representative malignant rare disease with an average 5-year survival rate of less than 7%. It is known that approximately 12,000 new patients are diagnosed annually in the United States alone. Since the U.S. Food and Drug Administration (FDA) approved Temodal and Avastin as treatments, no new drugs have been developed for nearly 14 years, making it a typical intractable disease.

Terry Hyland, Chief Scientific Officer of Immunomic, stated, “The dosing of the first patient is proceeding smoothly, marking a new milestone in our drug development journey dedicated to glioblastoma treatment. Through this clinical trial, we will do our utmost to provide patients with effective and safe therapies in the glioblastoma field, where treatment alternatives are extremely limited.”

Donggeon Kim, Head of HLB USA, also said, “While Immunomic’s other cell vaccine ITI-3000 is entering the final stages of Phase 1 for Merkel cell carcinoma, a malignant skin cancer, the initiation of Phase 1 dosing for newly diagnosed glioblastoma further enhances the value of the UNITE platform technology. As HLB’s U.S. subsidiaries continue to achieve steady results across various indications such as liver cancer, glioblastoma, and hematologic cancers, HLB’s corporate value will continue to grow in the long term.”

Meanwhile, ITI-1000, which has completed Phase 2 targeting GBM and is currently undergoing data analysis, is a cell therapy that extracts immune cells from the patient’s body, loads target antigens, and reinfuses them back into the patient. In contrast, ITI-1001, for which Phase 1 patient dosing has now begun, is a therapeutic vaccine that directly injects antigens to activate immune cells.

Immunomic, having confirmed the technological capabilities of UNITE through the university-led ITI-1000, is now conducting full-scale clinical trials aimed at commercialization with more advanced therapeutic vaccines ITI-1001 and ITI-3000.